2018 Site Solutions Summit Faculty

Greg Adams
Director Clinical Site Management
Greg has more than 25 year of experience in the pharmaceutical industry. He has extensive site-facing experience, including CRUs and currently leads a site-facing team responsible for operational oversight of clinical trials and identification and management of strategic site/investigator partnerships and relationships – an area he had been engaged in for over 15 years. He has broad expertise in all phases of clinical trials, and starting in the industry as a Research Pharmacist, has extended experience in disciplines in Discovery Research, Pharmaceutical Science, and Pharmacology. Greg is the business Lead for the Pfizer Investigator Training Program – a program for new investigators/staff.
Gail Adinamis
CEO and Founder
GlobalCare Clinical Trials
Gail Adinamis is the CEO and Founder of GlobalCare Clinical Trials. She has over 35 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She founded the business model for centrally managed homecare services for clinical trials in 1992.
Roberto Aguirre, MD, CPI, CCRP
VP/Global Research Director
AGA Clinical Trials
Roberto is a foreign physician with 13 years of experience in clinical research. He is the VP and owner of AGA Clinical Trials (operating in the USA and Ecuador), which has conducted more than 150 trials since 2004.
Gail Akiyama Hanley, RN, BSN
Director, Clinical Operations, Head of Site Account Manager
Gail Akiyama Hanley earned her BS in Nursing from the University of Washington. She worked as a hospital staff nurse for five years in Burn/Reconstructive Surgery, Neonatal Intensive Care, and Operating Room, then entered the pharmaceutical industry as a professional representative with Roche Laboratories. Gail began her career at Merck in 1988 as a Professional Hospital Representative, followed by positions as a Urology Health Sciences Liaison Associate, Medical Research Associate, Clinical Research Operations US Regional Manager and Clinical Research Manager assigned to vaccine and cardiology trials, before leading the Site Account Manager Team established in 2017. She is currently a member of the TransCelerate Shared Investigator Platform External Engagement-SMO sub-team.
Moe Alsumidaie, MBA, MSF
Head of Research
Moe Alsumidaie is a business strategist, who specializes in data analysis and predictive modeling in clinical trials. Currently, Moe heads up CliniBiz, which is a research enterprise that partners with investigators to expand new and existing research initiatives in the clinical trials industry. Moe holds extensive experience in Phase I-IV, IDE and 510(K) clinical research and healthcare business operations, having worked in-house for Stanford Medical Center, Abbott Vascular, Genentech and Roche. Moe merges technical methods from the world of business and investment finance into clinical operations, and has demonstrated successful results in improving clinical trial and healthcare business outcomes via breakthrough strategies. 
CAPT Richardae Araojo, PharmD, MS
Associate Commissioner for Minority Health/ Director, Office of Minority Health
U.S. Food and Drug Administration
CAPT Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health at the U.S. Food and Drug Administration (FDA). In this role,she provides leadership, oversight, and direction on minority health and health disparity matters for the Agency. CAPT Araojo previously served as the Director of the Office of Medical Policy Initiatives in FDA’s Center for Drug Evaluation and Research (CDER), where she led a variety of broad-based medical and clinical policy initiatives to improve the science and efficiency of clinical trials and enhance professional and patient labeling. CAPT Araojo joined FDA in 2003, where she held several positions in CDER’s Office of New Drugs. CAPT Araojo received her Doctor of Pharmacy Degree from Virginia Commonwealth University, completed a Pharmacy Practice Residency at University of Maryland, and earned a Master’s degree in Pharmacy Regulation and Policy from the University of Florida.
Rick Arlow, MS
Founder & CEO
Complion founder Rick Arlow was immersed in clinical research during a NIH-funded MD/PhD medical scientist training program at Case Western Reserve University, which resulted in publications with several leading journals including Neuroscience. Although he loved the work, he was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Inspired by his experience and drawing on his engineering background, Rick put together a world-class team experienced in clinical research and enterprise content management to build Complion, the first and only eRegulatory platform built specifically around the needs of clinical research sites. Rick is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS. He was involved with a biotech business resulting in several patents and was recognized in Business Week’s “Top 25 Under 25 Entrepreneurs”.

Sarah Attwood
Director of Client Services
IntegReview IRB
Sarah has over 20 years of experience in Operations and Business Development in Clinical Research. Prior to joining IntegReview in 2014, Sarah was the Vice President for MetaClin Research. She was responsible for the clinical operations of their multiple Phase I – IV clinical research sites and developing the CRO business to provide project management and monitoring services. Prior to management, Sarah has held various positions including Clinical Research Coordinator, CRA, Project Manager and Consultant for CROs and Sponsors and has a background in hospital research, pharma, medical devices, nutraceuticals and biotech.

Wayne Baker
Chief Commercial Officer
As Greenphire’s Chief Commercial Officer, Wayne is responsible for the global commercial strategy of the rapidly growing organization, including the execution of sales and marketing programs. Wayne is a proven strategic sales executive with more than 25 years of commercial experience in technology and life science industries. Prior to joining Greenphire in 2016, Wayne served in numerous senior leadership roles at Advanced Health Media (AHM), a leading global provider of SaaS-based solutions designed to manage compliant interactions with healthcare professionals and organizations. During his tenure, Wayne helped establish AHM as the market leader, playing an integral role in the organization’s 1500 percent revenue growth during a four-year period. Earlier in his career, Wayne gained sales leadership and industry experience at Parametric Technology Corporation (PTC) and Brent International. He earned his bachelor’s degree in Chemical Engineering from Drexel University. Wayne resides in the Philadelphia area with his wife and four children.
Gretchen Bakhshai
Vice President
Clinical Trial Solutions at Axiom
Gretchen Bakhshai has nearly 20 years of life science / pharmaceutical industry experience at TAP Pharmaceuticals, Takeda, Novo Nordisk, and IQIVA, where she demonstrated expertise and leadership in biopharmaceutical sales for a broad number of therapeutic areas, market access and managed care contracting and execution, numerous product launches, sales operations, and commercial outsourcing consulting. She joined Axiom 9 months ago as VP, Clinical Trial Solutions at Axiom, and has since implemented a successful go-to-market strategy, built strong relationships with CROs, Sponsors, and Sites, and is continuing to drive adoption of industry-wide disruptive innovative solutions for clinical trial contracting by leading the commercial function for Axiom’s CTA product. Gretchen has a bachelor’s degree in Industrial Engineering from Rutgers University and an MBA in Finance from St. Joseph’s University in Philadelphia.
Lauren Ballina Chang, MS, CCRP
National Program Director
Clinical Research Fastrack
Lauren is a Pittsburgh native who graduated with a degree in Psychology and Latin from the University of South Carolina. She later earned her Masters of Biomedical Science from Midwestern University. She has several years experience as a study coordinator, working on both clinical trials as well as longitudinal observational studies. She has worked on both academic and industry-sponsored studies and has experience with study design, protocol development, study start-up, data collection and analysis, and publication. She served as a SoCRA certified Clinical Research Coordinator at The Mayo Clinic in Phoenix, AZ before taking the position of National Program Director at Clinical Research Fastrack. She is passionate about educating a new generation of entry-level clinical research professionals.
Brian Barnes
Director, Clinical Development Services, Adaptive and Intelligent Monitoring (RBM)
Brian is responsible for the implementation and oversight of the Adaptive and Intelligent Monitoring (AIM) and assists with the general implementation of the Risk Based Monitoring (RBM) strategy. Brian had a role in the early development of PPD's AIM strategy over 7 years ago as a CRA. He moved into a full-time role with the AIM group 5 years ago and has progressed into a Director role. Brian holds a Master of Arts in Exercise Physiology from the University of Texas at Austin and a Bachelor of Science in Kinesiology from San Diego State University. Brian lives in Madison, WI with his wife and trusted office assistant tripod boxer dog Bella. When not in the office Brian can be found outdoors with some of his favorite activities being mountain biking, skiing, and trail running.
Anne-Marie Baughn
Director, Business Development
Rx Trials, Inc.
Anne-Marie Baughn has been with Rx Trials for over 21 years. Anne-Marie has been Director of Business Development for Rx Trials for the past 19 years. She is primarily responsible for developing and identifying clinical research opportunities and marketing RxTrial's clinical research sites to pharmaceutical and biotech companies, and clinical research organizations. Previously, Anne-Marie was the Director of The Congestive Heart Failure Clinic at Georgetown University Medical Center for seven years where she was responsible for all administrative, clinical, and research related activities related to the department. Anne-Marie is a former cardiac critical care nurse. She holds both a Bachelors of Nursing degree and a Masters of Nursing in Administration degree from Georgetown University. She is also a member of the Association of Clinical Research Professionals. Anne-Marie is a frequent speaker at several industry conferences including ACRP, DIA, and MAGI.

David Blume
Managing Director
Edgemont Capital Partners
Mr. Blume is a co-founder and Managing Director of Edgemont Capital Partners and has over 30 years of investment banking experience, including more than 25 years representing healthcare companies in M&A and capital raising transactions. He has completed over 125 transactions, representing more than $35 billion in value. He has provided strategic advice and raised capital for pharmaceutical research and development services companies such as CROs, clinical sites and networks, and other pharma services companies. David has closed over 25 M&A transactions for clinical research site companies. He graduated from Haverford College with a Bachelor of Arts in Philosophy in 1988.
Reg Blynn
Global Head of Business Development, Qcare
Reg Blynn started his medical career selling EHR’s and Billing systems back in 2001. Since then, Reg has played several key roles at various medical companies in the business development and sales arenas. After selling EHR’s and developing Clinically Integrated Networks for research at the eCast Corporation for 5 years, Reg joined PrimaryRx as their VP of Sales in 2006. This company provided family practice, urgent care centers and self-insured company doctors the ability to dispense medications directly to their patients at the point of service. In 2011, Reg decided to go back into clinical research and went on to form Medical Research Alliance, a 34-site network that spans across the US. MRA is still in existence today as one of the preeminent performing networks with partnerships across all the major Sponsors and CROs. While there, Reg created and developed a revolutionary software for business development in Clinical Research called Devana Solutions. Devana is also still running today with great success. In 2016, Reg decided to go over to the CRO side of the business and went to IQVIA (then Quintiles) as their Vice President of Client Services. His job there was to build and create a SMO under the business line called Qcare. In the first 3 years there, they have had tremendous success with a current active network of over 1,000 physicians at 8 large multi-specialty sites across the US. The expansion of Qcare will continue at IQVIA under Reg’s direction. In addition, Reg also runs the sales division of the Qcare CRC Network of Excellence, a division which places Clinical Research Coordinators across the globe to help with various protocols that need additional resources.

Angie Botto-van Bemden, PhD, ATC, CSCS
Director, OA Programs
Arthritis Foundation
Dr. Angie Botto-van Bemden, Director of Osteoarthritis Programs at the Arthritis Foundation, leads implementation of a virtual Osteoarthritis/OA Center of Excellence integrating mobile technology in clinical research. She has been directly involved in industry and academic research for over 20 years and conducted more than 20 clinical trials, with a focus on musculoskeletal disease.

Deena Bernstein, MHS
VP Site Services
Deena is directly responsible for leading the site operations of the Qcare affiliated sites. Qcare, an IQVIA company, is a site services provider that partners with sites to deliver operational efficiencies and site management services which provides their clients with full-service site support. Qcare sites are multi-therapeutic and conduct pharmaceutical sponsored and device studies (Phase II-IV). Deena has served on the Leadership Council of SCRS since its inception. Through her activity with SCRS she is on the Site Advisory Group (SAG) for TransCelerate’s Investigator Global Platform.
Deena graduated from Seton Hall University and also received a Certificate in Clinical Research Administration and a Master in Health Sciences in Clinical Research Administration from George Washington University.
Lisa Bjornestad
Director of Site Alliance
Lisa Bjornestad has over 20 years of clinical research experience. She has extensive experience in site operations, having directed both early and late phase research centers for the better part of her career. She has also worked in Project Management and Business Development. Currently, she is the Director for the PAREXEL Site Alliance program in the Americas.
Michael Bonavilla
Senior Sales Executive
Michael Bonavilla is a Senior Sales executive with Bio-Optronics and has been working with the industry leading CTMS, Clinical Conductor for over 10 years helping research sites, CROs, hospitals and site networks streamline their overall research efficiencies. Michael and Bio-Optronics have been supporting the Site Solution Summit for the last 9 years continuing to help deliver best practices to technology to research organizations. More personally, Michael enjoys spending time with his wife and four children.
Susan Booth
Director mHealth Client Services
Medidata Solutions
Susan is a member of Medidata’s Professional Services team, managing a team of Mobile Health experts to analyze, design, and deploy eConsent and Virtual Trial solutions for clinical trials. She is an accomplished technology leader with over 25 years of experience in software design, development and implementation. Susan has a celebrated career in managing diverse teams to deliver technology products in research, business-to-business, and government environments. She was the Director of Development for Hoover’s Online, managing the development of the B2B website used by businesses worldwide to gain competitive market knowledge and stayed with Hoover’s through their acquisition by Dunn & Bradstreet. Susan also has an extensive background in pre-clinical and clinical systems development and implementation for leading pharmaceutical, biotech, and medical device companies. Susan holds a Bachelor of Business Administration degree in Computer Information Systems from the University of Texas at Austin and resides in Austin, Texas
Lisa Bozza Archer
Customer Success Manager
Complion, Inc.
As a former Clinical Research Associate with one of the largest CROs, Lisa obtained a strong foundation in clinical research. She also gained additional exposure to site operations while working in the Compliance Office of an Academic Medical Center, where she helped support investigators with regulatory and research tasks. These experiences provide her keen insight, both to the needs and the daily experiences of Complion’s clients. As an Account Manager of Complion’s Customer Success Team, Lisa regularly engages with clients to promote successful adoption and utilization of the Complion System. She actively educates and promotes awareness of Complion’s solution to clients and the research community. She also enthusiastically advocates for sites by leading Complion’s initiative to provide free educational webinars to the research community. Lisa shares the Complion team’s intrinsic motivation to reduce the burden on research sites, while increasing efficiency and compliance throughout the industry.
Christina Brennan, MD
DVP Clinical Research
Northwell Health
Dr. Christina Brennan is a physician who has devoted her career to clinical research. She is committed to the advancement of science and medicine. She is currently the Vice President for Clinical Research for Northwell Health in NY. She has over 18 years of extensive clinical research experience, including over 14 years in clinical research management roles. She is the President of the NY Chapter of the Association of Clinical Research Professionals. She works on many projects including one on qualifying investigators in clinical research in collaboration with Duke, the FDA, the NIH and other key stakeholders. Dr. Brennan has authored chapters in textbooks, co-authored many manuscripts and abstracts and has presented at numerous scientific meetings. She is also one of the 2015 and 2016 honorees of the Irish America Healthcare and Life Sciences 50, which recognizes the work of Irish-American and Irish-born medical professionals. Dr. Brennan earned her M.D. from the West Indies, her M.B.A. with distinction from Hofstra University and her B.S. from St. John’s University.  
Brian Bromberek
VP Clinical Operations
Cardiovascular Research Consortium, LLC
Brian Bromberek is the Vice President of Clinical Operations at CRC, assisting sites with CV Research opportunity and handling participation in monetizing their data for Real World Evidence. He has 20+ yrs. in Life Sciences and Cardiology EHR Sales.
Christian Burns
Christian’s passion for clinical research began when he first participated in a clinical trial at a young age. Since then, his fascination with the industry and entrepreneurial spirit has continually pushed him to find ways to transform and improve upon existing processes, from site operations and management to digital marketing and technology. Through his leadership of three companies, GuideStar Research, BTC Network and ClinEdge, Christian continues to expand much needed services and offer more innovative solutions within the clinical research space. 
Jennifer Bush
Director, Life Sciences Product Strategy
Jennifer is a life sciences professional with over 19 years of industry experience in both business and IT environments.  Jennifer has worked in large pharma, large CRO and IT, working in both business and IT departments managing data transformation and loading, eClinical implementations including implementation of EDC, clinical trial management and other clinical systems.   Jennifer now works as a Life Sciences Product Strategist at Oracle focusing on clinical trial planning, management and monitoring offerings and risk-based monitoring.  

Dustin Caldwell
Director of Strategic Development
Optimed Research
Dustin studied Developmental Health at the University of Hawaii. His clinical background is primarily in emergency medicine where he worked in Honolulu at Straub Hospital and Queens Medical Center. He also spent a year in the surgery department at Stanford University Medical Center. Dustin became involved in research in 2011, when he began working in research on pediatric pulmonary disease. He joined Optimed Research in 2013. Dustin enjoys reading and the outdoors; he plays rugby for a local Columbus team.
Miaesha Campbell, BA
Associate Director of Patient Recruitment
Miaesha oversees the global patient recruitment department at Medpace, a Clinical Research Organization based in Cincinnati,OH. She joined Medpace in October 2016 to develop the patient recruitment department at the company. Since joining Medpace, the department has successfully grown under her leadership. Miaesha leads her team, consisting of senior managers and coordinators, to drive patient recruitment processes and provide alternative solutions and guidance to clinical trial teams especially for those clinical studies that are more difficult to enroll.
Miaesha graduated from California State University at Dominquez Hills in May 2002, earning a Bachelor of Arts degree in English and minor in Communications. Her early career was spent in Public Relations, developing campaigns focused on community relations, consumer and travel products. She was recruited to support the marketing of clinical trial programs in 2007 geared toward educating patients and caregivers about the opportunities to join clinical research studies. This includes execution of large scale project strategies for the recruitment and retention of subjects in clinical trials through paid media, community, and site relations for global clinical trial recruitment and retention campaigns. Miaesha is a proud member of Delta Sigma Theta sorority and enjoys spending her spare time with her three children, Levon, Javon and Hannah.

Leslie Carney
Marketing & Recruitment Director
Bioclinica Research
Leslie Carney is the Marketing and Recruitment Director for Bioclinica Research. In her role, she centrally manages recruitment for the company’s four sites in Florida as well as the Patient Recruitment and Retention company (formerly known as Medici) who provide end-to-end global marketing and recruitment services to sponsors. Prior to clinical research, Leslie worked in the non-profit sector in the arts, higher education, and independent schools as a fundraising professional. Leslie received her BA and MBA at Rollins College and serves on the boards of United Arts of Central Florida, the Parkinson’s Association of Central Florida, and the Alzheimer’s and Dementia Resource Center.
Cary Carrion, BS
Regional Director
Clinical Site Partners, LLC
Cary Carrion, BS, is the Regional Director of Clinical Site Partners, LLC which is a network of research sites in the USA. From the institutional level, Cary has over 12 years of experience coordinating protocols, building and training teams, auditing trials for quality assurance, contract and budget negotiation, business development and creating site processes/procedures. Additionally, Cary has expertise in conducting Phase I - IV clinical trials in the following indications such as cardiology, family medicine, gastroenterology, respiratory, sleep, and CNS trials. Cary is passionate about increasing site efficiency and providing industry guidance and resources so all research staff is trained accordingly. Cary holds a Bachelor’s of Science in Interdisciplinary Study with a minor in Leadership studies from University of Central Florida. 
Jenine Caulkins
Vice President, Head Oncology Clinical Project Management
Bayer Healthcare Pharmaceuticals
I have 27 years of pharmaceutical industry knowledge specializing in clinical development research trials ranging from phase I-IV studies. My primary focus in the last 18 years has been in the Oncology therapeutic area. My pharma knowledge includes 15 years of working at Pfizer in Clinical Development and Development Operations focusing on Central Nervous System, Cardiovascular and Oncology. For the past 12 years at Bayer, I have been working in Oncology, Cardiovascular, and NOHI (Neurology, Ophthalmology, Hematology and Immunology) in Clinical Development and Clinical Project Management.
Janet Christoff, BA, RN, CCRA
Manager, Regional Field CRAs
Seattle Genetics
Janet Christoff is a registered nurse who has been in the field of clinical research for over 20 years. She has worked for both CRO and sponsor companies in various therapeutic areas, beginning her career as a study coordinator, moving to the role of CRA and then into clinical trial management. She is currently a manager of regional CRAs with Seattle Genetics, a bio-tech company focused on the development of innovative treatments for patients with cancer. Throughout her career she has worked closely to improve communication with site staff, collecting feedback on protocol design and operational aspects of clinical trials. She recently took a leadership role in developing the Quality Control program for CRA staff, to ensure quality oversight at each clinical site.
Jae Chung, MBA, CPA
Founding Visionary
Jae Chung is the founding visionary of goBalto. Jae previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical company and was a strategy consultant with McKinsey & Company. In 2013 he was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. A startup evangelist, Jae has also mentored healthcare technology startups through Rock Health. Jae has an MBA from New York University and holds a CPA.
Ivor Clarke
Ivor Clarke is the CEO of SubjectWell, the first risk-free clinical trials marketplace for patient recruitment. SubjectWell engages the 96% of Americans who have never participated in a clinical trial and only charges for patients who randomize. Ivor has over 12 years of C-suite experience in online marketing and specializes in the creation and operation of enterprise-class SaaS solutions. Before SubjectWell, Ivor served as President of Brightfire, an internet marketing and call center operation that helps more than one million people a month find better jobs by providing job matching and career support. Ivor has also held positions at Datran Media, where he delivered a 150% increase in revenue while improving customer satisfaction, and Microsoft, where he oversaw the user interface for Mac Office. Ivor graduated from Carnegie Mellon University, earning degrees in Human Computer Interaction and Information and Decision Systems.
Steve Clemons, MSN, FNP-BC, NP-C
VP of Operations
VitaLink Research
Founding Principal of VitaLink Research – a wholly owned and fully integrated private equity-backed site management organization. He currently serves as Vice President of Operations and board member. Steve has 19 years of clinical research experience in all phases and types of clinical trials. VitaLink Research has 11 locations in NC, SC and GA and is currently reviewing acquisitions to grow 4x in the next 4 years.

Nicole Cohen, MA
Global Head, Site Partnerships
Nicole Cohen is the Global Head of Site Partnerships at Covance, where she brings extensive experience working cross-departmentally and leading global teams, including 12+ years within clinical roles at IQVIA, and another 4+ years within various research site settings (private practice, university hospital, and research-only centers). Nicole’s past roles have included Head of Global Site Identification, Director of CNS Project Management, Partner Site Relationship Management, Clinical Research Associate, and Clinical Research Coordinator. Nicole received her B.A. Degree in Psychology from the University of Richmond and her M.A. in Clinical Psychology from the University of Delaware.
Kathy Cole, RD, LDN
Associate Director of Feasibility
PMG Research, Inc.
Kathy joined PMG Research in 1997 and is currently responsible for the network feasibility team at PMG Research. She has served in various roles within PMG inclusive of Clinical Trial Coordination, Site Management, Quality Assurance, Information Technology, and Business Development. Kathy has spent the last 14 years dedicated to PMG trial feasibility and precision trial placement. “Securing the right trials and enrolling patients are critical components to uphold PMG’s mission of bringing clinical research to as many lives as possible. I am very dedicated to using technology and data analytics in selecting appropriately matched trials for the patient communities we serve. I am equally as passionate about using data analysis to predict performance, reduce cost, and ultimately drive successful outcomes for our industry partners.” 
Matt Cooper, BSc, PhD, Cert IOD
Business Development & Marketing Director
NIHR Clinical Research Network 
The National Institute for Health Research Clinical Research Network is the research delivery arm of the NHS. It invests some £300m each year into an infrastructure of specially-trained clinical research professionals across England, to support rapid study set-up and patient identification/recruitment into clinical research studies, academic and commercial. In 2017/18, the NIHR CRN supported the recruitment of over 725,000 participants into clinical research studies - 50,112 of these were recruited into commercial contract clinical trials. As the Business Development & Marketing Director at the Coordinating Centre since 2014, and recently also taking on Research Delivery Director role, Matt brings a wealth of experience to the post, having been part of the Network structure for many years. In a previous role, he was a member of the leadership team for the Cancer Specialty, and before that worked in the Clinical Research Group of AstraZeneca for a number of years. 
MarieElena Cordisco, MA, APRN, NP-C, CCRC
Director of Clinical Trials
Western Connecticut Health Network 
MarieElena Cordisco, MA, APRN, NP-C, CCRC is an experienced family nurse practitioner with a specialty in endocrinology and research since 2006. She earned a Master of Arts in Professorial Nursing, Post Masters Certificate Family Nurse Practitioner and Certificate of Graduate Study in Public Health. In 2015, Ms. Cordisco became Director of the Office of Clinical Trials at Western Connecticut Health Network. She leads a team of professionals managing clinical trials for three hospitals and 70 outpatient offices in more than a dozen therapeutic areas. As a research leader, Ms. Cordisco has special interest in increasing nurse practitioner-led clinical trials. In 2018, she was invited to join the leadership council for the Society for Clinical Research Sites. She sits on the steering committee for the Joseph L. Belsky Research Day and the inaugural Spark Tank Employee Idea Challenge for her organization.
Anthony Costello
Vice President
Mobile Health
Anthony Costello is Vice President of Mobile Health at Medidata. After beginning his clinical research career at Genentech 20 years ago, Anthony Costello has gone on to co-found several clinical trials technology start-up companies including Nextrials (acquired by PRA Health Sciences) and Mytrus (acquired by Medidata). Over his career, he has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites and sponsors. He has been selected as one of the PharmaVoice Top 100 Most Inspiring People in Clinical Research, has served as Chairman of the Board for the Society for Clinical Data Management and is currently a member of the editorial advisory board for Applied Clinical Trials magazine. He is a frequent author and presenter on topics related to the efficient use of technology in clinical research and has a degree in Sociology from UC Berkeley.
Darren Cowan, RPN
Global Site & Study Operations, North America Area Head
Darren has been with Pfizer for over 18 years, and in his current role of North America Area Head within the division of Global Site & Study Operations. He has overall responsibility for and accountability to deliver strategic and operational direction to the area management & staff to ensure deep understanding and execution of strategy, culture, and goals.
Prof. Edward Czerwinski
Krakow Medical Centre
Professor Edward Czerwinski, founder and head of Krakow Medical Centre since 1996 and Professor of Jagiellonian University being the Head of the Department of Bone and Joint Diseases. He has been a practicing medical doctor in orthopaedics for 46 years as well as an active university lecturer, scientist and community benefactor. In Krakow Medical Centre he supervised 124 trials that have been completed in the fields of: cardiology, bone and joint diseases, endocrinology, dermatology, gastroenterology, hematology, kidney, rheumatology, osteoporosis, neurology, nephrology, pain management. Prof. E.Czerwinski is a member of the international Scientific Advisory Boards of: International Foundation of Osteoporosis, EULAR and EFFORT, 10 boards of scientific international magazines, member of 20 societies, organizer of 21 medical congresses in Poland including World Congress on Osteoporosis in 2018. Author of 502 publications, Impact Factor of 191 and Hirsh index 16. 
Ben Daniel
Director of Business Development
Ben has over 15 years of industry experience in accelerating and improving clinical trial start-up through the utilization of innovative technology and process solutions. At goBalto, Ben leads the go-to-market efforts in helping sponsors, CROs and investigative site networks decrease overall cycle times associated with site identification, selection and activation.
Denise D'Aruia, PMP
Project Manager
Denise D'Auria, PMP, joined Medidata after several years with ERT and iQVIA where she developed successful implementation plans and execution strategies for eCOA and EDC implementations for clinical research studies. Denise is currently working for Medidata to refine processes and develop best practices to successfully implement a variety of eCOA studies on Medidata's eCOA/ePRO app in conjunction with the Rave platform.
Glen de Vries
Glen is the President and Co-founder of Medidata Solutions, the leading cloud platform for life sciences research. Glen has been driving Medidata's mission since the company’s inception in 1999: Powering smarter treatments and healthier people. His publications have appeared in Applied Clinical Trials, Cancer, The Journal of Urology, Molecular Diagnostics, STAT, Urologic Clinics of North America and TechCrunch. He is a trustee of Carnegie Mellon University, a Columbia HITLAB Fellow, and a member of the Healthcare Businesswomen’s Association European Advisory Board. Glen received his undergraduate degree in molecular biology and genetics from Carnegie Mellon University, worked as a research scientist at the Columbia Presbyterian Medical Center and studied computer science at New York University's Courant Institute of Mathematics.

Eric Delente MM
President, Patient Solutions
DrugDev, an IQVIA company
Eric has been innovating, designing, and developing clinical education and tracking systems for patients and providers for more than 20 years. Eric co-founded and led the design and development of the SecureConsent, one of the first eICF systems to market, starting in 2005. SecureConsent has been successfully deployed in hundreds of studies across the globe for leading pharma companies, CROs and Hospital networks. In 2016, SecureConsent became part of DrugDev, an IQVIA company. Since then his focus has been on broadening the global adoption of eConsent and making it a standard across the industry.
Theresa R. Devins, DrPH
Senior Associate Director
Boehringer Ingelheim
Dr. Theresa R. Devins has worked for Boehringer Ingelheim Pharmaceuticals, Inc. for nearly 14 years. During this time, she has accumulated expertise in the conduct of international trials with specific focus on retention efforts and minimization of missing data. Theresa has identified, developed and maintained strategic partnerships with external organizations in order to enhance the customer voice in BI’s clinical trials. Theresa has earned a Master’s Degree in Clinical Research Administration and a doctorate in Public Health. She strongly believes in health equity for all and devotes a good deal of effort to increasing representative populations, especially minority patients, in clinical trials. Theresa is a member of BI’s Cross Cultural Leadership Team and oversees an extended working group on clinical trial diversity with the department of Medicine.
William Dirkes, MD, MBA
Sentral Clinical Research Services & SentralBinders
Dr. Dirkes has owned and operated Sentral Clinical Research Services for eight years. During that time, Dr. Dirkes has implemented innovative solutions that allowed the research site to function paper-free. He developed SentralBinders as a user-friendly, validated, regulatory-compliant means of becoming paper-free at the site. The research site has been using SentralBinders now for 1.5 years. Dr. Dirkes achieved front-line experience managing the transition process, staff acceptance, regulatory issues, and resolving sponsor/CRO concerns. His site has experienced significant efficiencies by becoming paper-free, and site staff report greater work satisfaction related to less paper filing. Dr. Dirkes received his MD degree from the University of Cincinnati and his MBA degree from the Kellogg School of Management at Northwestern University. He is a board certified Anesthesiologist and practiced anesthesia for 15 years before moving into the clinical research arena. Prior to starting his site, he was the COO of Goodwyn IRB. 
Robin Douglas, MA, CCRC
Head of Site Operations
Virtual Trials at IQVIA
Robin Douglas has 24 years of clinical research experience, including 12 years as a site manager/administrator.

Since joining IQVIA in 2008, Robin has served in multiple roles designed to enhance investigator site relationships and bring innovative new project delivery models to life. Currently, Robin serves as Sr. Director, Head of Clinical Operations for IQVIA Virtual Trials. Her core responsibility is oversight and delivery of the IQVIA Virtual Trial team and Virtual Trial PI Network. Previously, she served as Director, Site and Patient Networks, and worked to ensure an enhanced site experience including improved site strategies in CNS, and a new strategy for our Prime and Partner Sites in North America. Robin has also served as Site Solutions Director, focused on enhancing communication and engagement with investigator sites globally, and Director of Site Management, responsible for the performance of the IQVIA Prime and Partner Program for multiple regions of North America.

Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Clinical Research Strategy Executive
Molly has over 20 years of healthcare experience with specialization in oncology, research, and health care administration. Molly earned her bachelors of nursing and master of health administration as well as achieved and maintained her nurse executive advanced, oncology nurse, and clinical research coordination certifications. As a former director of a leading phase I clinical trial site, she has proven her ability to streamline processes resulting in improved clinical operation efficiencies, financial gain, and employee and patient satisfaction. Now Molly shares her passion, experience, and expertise with sites as the strategy executive for Medix Clinical Research.
Lisa Dyment BA
Director, Strategic Site
PPD, Inc.
Lisa is a clinical research professional with over 22 years of experience in project management, proposal strategy, feasibility and site network relationship management in the CRO environment. Her strengths are in collaborative strategy development across multiple departments and regions, ability to assess client needs and develop a ‘big picture’ strategy to deliver, ability to interpret data and make recommendations to clients based on this data to meet the ultimate goals of their development plan.
Debbie Elliott PhD
Executive Director, Feasibility and Proposals,Clinical Operations
Debbie Elliott has over 20 years of clinical research experience, including over 4 years in Phase 1 research and over 16 years in Phase 2/3 clinical trials. She holds a PhD in Biological Psychology with a minor in Neurobiology. Debbie’s therapeutic experience includes neuroscience, cardiovascular, endocrine, respiratory, digestive disease, and immunology. Debbie has directly managed over 50 studies ranging from small first in human studies to a large Phase 3 cardiac/stroke prevention trial conducted in 40 countries with over 1200 sites and 18,000 patients enrolled. She has provided senior level oversight for many other studies to ensure that high quality deliverables are consistently provided. Most recently, Debbie directed the global Study Start-Up team within Medpace and currently oversees the Proposal and Feasibilities team.
Mary E. Elmer, MSN, CRNP
Director-Patient, Caregiver and Consumer Experience Org.
Merck and Company, Inc.
Patient Innovation and Engagement Director- in the Office of the Chief Patient Officer Merck & CO, Inc. Mary Elmer is the director of the Patient, Caregiver and Consumer experience at Merck. This group seeks to create an experience that engages consumers and patients in optimizing their health, well-being, and healthcare outcomes. She also leads a team for global patient engagement in the office for the Chief Patient Officer at Merck & Co., Inc. This team is actively involved in bringing the voice of the patient into the drug development process at Merck through strong collaborative partnerships with patients and organizations serving patients. Mary is a board-certified nurse practitioner with over 18 years of experience at Merck, working in all phases of drug development and implementing global strategic initiatives. Mary is a member of the Global Diversity and Inclusion council at Merck and co-leads the diversity in US clinical trials initiative, which seeks to ensure our clinical trials are representative of diverse patient groups. Mary is a member of TransCelerate Biopharma, and leads a work stream on patient engagement. Mary obtained her Master of Science in Nursing degree from the University of Pennsylvania. She is a Six Sigma green belt who has experience in executing organizational change and cross-company initiatives, such as implementing clinical trial data sharing at Merck, in alignment with trade organizations (EFPIA/PHRMA) and regulatory bodies.
Marie Emms,
Head of Patient Engagement
Marie Emms has 20 years of experience in healthcare communications, spanning PR, medical education and patient engagement. She has spent the past 15 years focused solely in patient engagement, supporting pharma, biotech and CRO clients. She specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness, consent through to compliance and adherence. Marie has worked on a wide variety of therapeutic areas across neonatal, pediatric, adult and geriatric studies.
Audrey Escotto, MD
Site Director
Emerson Clinical Research Institute
Dr. Escotto is a trilingual Medical Doctor who has more than 3 years of experience in clinical research including 2+ years serving as a Sub-Investigator focused on adult primary care and women’s health. She is fluent in English, French and Spanish. Dr. Dr. Escotto obtained her M.D degree at the prestigious Francisco Marroquin University, in Guatemala, and she is currently pursuing her Master in Public Health at George Washington University. Dr. Escotto joined Emerson Clinical Research Institute (ECRI) in 2016, where she has shown her hard work and commitment to patients whose needs are unmet by the public and private system. Currently, she is the ECRI Site Director and oversees several clinical sites in Northern Virginia and Washington D.C. Dr. Escotto is passionate about improving health care access for minority populations. During her free time, she enjoys playing guitar, tennis, traveling and spending time with her 5-months son and family.
Zachariah Evangelista
Ser and Associates
Zachariah Evangelista, with Ser & Associates, focuses his practice on corporate and business law. Zachariah regularly represents clients in negotiating clinical trial agreements, service provider agreements, as well as, matters of compliance, corporate structuring and restructuring,and purchase and sale transactions.
Lauren Falcone APRN
Meridian Clinical Research
As chief operating officer, Laura Falcone directs operations at all Meridian sites across North America. An advanced practice registered nurse (APRN), Falcone brings years of firsthand clinical experience to her executive role at Meridian. She established Meridian’s excellence in patient-centric research conduct and remains heavily-involved in day-to-day clinical operations, occasionally serving as sub-investigator for trials. In 2012, Falcone was named Clinical Research Coordinator of the Year at the PharmaTimes U.S. Clinical Researcher of the Year competition. Before joining Meridian, Falcone was an intensive care unit nurse at the Methodist Health Systems. She earned her Bachelor of Arts in Psychology and Biology from the University of Virginia; a Bachelor of Science in Nursing from Creighton University; a Master of Science in Adult Acute Care and a Post-Master's Certificate in Family Practice Nursing from the University of Nebraska Medical Center.
Kristin M. Ferrigno, MLAS, LATg
Director of Site Development and Operations
Care Access Research
Kristin Ferrigno is the Director of Site Development and Operations at Care Access Research where she leads staff hiring, development, and retention. Care Access Research specializes in developing and supporting new clinical research sites across the country and Kristin leads the staffing operations for all company locations. With over 15 years of clinical research management experience, Kristin has worked closely with her team to develop robust recruitment channels, staff development opportunities, and an all-out attractive workplace built on a culture of teamwork. Her efforts have made Care Access Research a leader in clinical research talent acquisition, development, and retention. Throughout these efforts, Kristin has built off of her extensive management experience, including from her time at MIT, Novartis, and Biogen. Her goals are to increase the clinical research talent pool and to enable new and old industry experts to make clinical trials a care option for every patient.
Diana Foster, PhD
Vice President, Strategy & Development
Diana Foster, PhD, is the Vice President of Strategy and Development for the Society for Clinical Research Sites and is responsible for building relationships with industry that help amplify the voice of the clinical research site. She is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing tactics. Diana has designed and facilitated site management and patient recruitment trainings across the globe.
Peter Fredette
Director, Oncology
Peter Fredette has almost 20 years of experience in the drug development industry, including pre-clinical toxicology and all phases of clinical research. He is most experienced in oncology, but has worked across more than a dozen therapeutic areas. Peter’s current responsibilities include supporting CRO-Site alliances and thought leader engagement; site strategies for global and domestic oncology trials; and creating and implementing strategies to improve quality and accessibility of clinical trials for cancer patients around the world. Prior to this, Peter has held a variety of roles at IQVIA over the last 17 years, including trial monitoring, project management, and site & investigator relations.  
Debra Freedholm
Vice President of Client Services, Clinical Trial Solutions
Deb Freedholm is Vice President of Client Services, Clinical Trial Solutions for Axiom, the leading global alternative legal services provider.  In this role, Deb employs her extensive experience managing large operations and clinical contracting teams to support all aspects of client delivery for Axiom’s Clinical Trial Solutions. Prior to joining Axiom, Deb spent 20+ years in the pharmaceutical industry in a variety of leadership roles across Clinical Research, Clinical Operations, Business Operations and Corporate Licensing at Merck and Bristol-Myers Squibb.  She developed and led central Clinical Trial Contracting operations at both Merck and BMS.  Prior to joining Pharma, Deb spent 10 years as an RN at large academic centers as Head Nurse of a Clinical Research Center and as an ICU Nurse.  Deb has a bachelor’s degree in Nursing from Gustavus Adolphus College and an MBA from Wharton.
Nancy Fuller
Director Customer Engagement – Shared Investigator Platform
Nancy has more than 20 years experience in consulting, process reengineering, and technology implementation related to clinical trials. Her pharma experience includes roles in Clinical Development, Clinical Training, as an IT Business Partner, and as an Organization Development Consultant for a Clinical Organization. She also has served as a consultant, advising CROs and Pharma companies in the adoption new technologies and how to gain benefits from technology investments. As the Director of Customer Engagement for the Shared Investigator Platform, she is responsible for partnering with customers and users to establish product priorities, develop the product roadmap, and define requirements. She also oversees product training and communications.
Katie Gaiek
Account Executive
Katie is an Account Executive at Bio-Optronics, where she focuses on Clinical Research Software Applications. In her current role, Katie works with prospective clients within the Life Sciences industry to provide SaaS solutions to accommodate regulatory compliance and enhance clinical research operations. Before starting at Bio-Optronics, Katie was a Technical Account Representative at MediSked, LLC, a SaaS solutions provider to human service agencies, oversight entities and managed care organizations. Katie graduated from the State University of New York at Buffalo with a joint BA degree in Communication and Psychology. 
Steven Geller, MD, FACP, CEI
Medical Director
Rx Trials LLC
Dr. Steven Geller is Medical Director of Centennial Medical Group and of Rx Trials LLC. He graduated from Johns Hopkins Medical School and then did his internal medicine residency at Johns Hopkins Hospital. He has been an investigator in more than 85 clinical trials and is a certified physician investigator. 
Leesa Gentry
Director of Clinical Management
Ms. Gentry’s career spans 23 years within the CRO and pharmaceutical industries, including previous positions within Quintiles, Omnicare, and PPD. While at PPD, Ms. Gentry performed simultaneous roles of both Global Project Manager, and Sr. Research Specialist for Clinical Systems. While at Omnicare, Ms. Gentry was responsible for growth of a novel clinical research site network within long-term care. Her work in this area is featured in the Journal of Good Clinical Practice. Since joining Otsuka in 2005, Ms. Gentry has developed creative methods of trial implementation in clinical operations, data management and vendor management. Her work implementing registration trials within the developing world is featured in both the WHO Bulletin and Life Science Connect. Ms. Gentry received a Master of Arts in Psychology from the University of Mary Hardin-Baylor, and both a Bachelor of Arts in Psychology and Master of Science in Gerontology from the University of Central Missouri. 
Vanessa Gertsen
Manager, Global Site Relations
Acurian, Inc.
In 2012, Vanessa joined the Global Patient Recruitment and Retention company, Acurian Inc. She began her Acurian journey as a field team member. She currently works with the Global Site Relations Department and Global Enrollment Manager Team to effectively engage sites in the patient recruitment campaigns and drive enrollment at the site level. Vanessa has worked in the Pharmaceutical Industry for the last 15 years in multiple capacities.

Melynda Geurts, MS
Senior Vice President, Site & Patient Engagement
Total Clinical Trial Management
Melynda Geurts' career has focused on advancing education within the healthcare industry for the past 23 years. Since 1998, Melynda has shifted her focus on educating the public about participating in clinical trials through global programs. She currently serves as the Senior Vice President of Site & Patient Engagement for Total Clinical Trial Management (TCTM). Melynda will focus on TCTM’s commitment to strengthening relationships with research sites and Investigators as well as maintaining the company’s track record of meeting 100 percent of enrollment targets on all completed studies. Melynda is invited often to present and train worldwide at industry conferences and has contributed to the industry's overall body of literature through her writing contributions. Melynda holds a M.S. in Healthcare Administration and a B.B.A. in Marketing.
Dalvir Gill, PhD
Chief Executive Officer
TransCelerate BioPharma Inc.
Dalvir Gill, PhD, is the Chief Executive Officer of TransCelerate and serves on its Board of Directors.

Dr. Gill has more than 25 years of drug development experience. Prior to his appointment as CEO of TransCelerate in December 2012, Dr. Gill was the President of Phase II-IV Drug Development at PharmaNet-i3, an international contract research organization. In this role, he was responsible for a global business spanning nearly 40 countries and had P&L responsibility for all operational departments and business development.

Dr. Gill earned his BSc in Applied Biology from the University of Hertfordshire and his PhD in Pathobiology from the Royal Free Hospital School of Medicine, University of London. He also holds a diploma in the health economics of pharmaceuticals from the executive program of the Stockholm School of Economics. Dr. Gill has presented his research and spoken at numerous conferences, and has authored more than 30 scientific publications. He also is an elected fellow of the Royal Society of Medicine.
Angela Gill Nelms
Florence Healthcare
Angela has 10+ years experience driving clinical research efficiency and compliance. Her diverse sponsor/site experience includes improving inspection preparedness, activation/enrollment timelines, and implementing successful monitoring techniques. At Florence she drives the team to create easy-to-use resources that are complaint, reduce redundancy and errors, and ultimately lead to faster trial completion times. In her free time she is a mother, 6 time IRONMAN finisher, and student pilot.
Gretchen E. Goller, MSW
Global Head, Patient Recruitment and Retention Solutions
ICON plc
Gretchen has amassed over 20 years of clinical research experience, including work at the site, sponsor and CRO level. Gretchen leads the Patient Recruitment and Retention Solutions group at ICON working with a team of strategists to implement recruitment and retention programs on all pertinent ICON studies. Gretchen has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania.
Claudia Gomes, MS, CCRC
Director, Clinical Research and Scientific Intelligence
Syneos Health
Claudia has worked in the clinical research field for over 10 years. As a research director for a national physician management organization, Envision Healthcare, Claudia’s leadership and experience in research has provided her with a very broad perspective on research operations in over 700 facilities. Her responsibilities include research team building, developing physicians to become Investigators, integrating newly acquired facilities to central research processes, putting patients first, business development with sponsors and CROs, enterprise-wide research billing compliance, and much more. Claudia is currently overseeing over 150 studies from confidentiality to close-out by ensuring feasibility at the site level, legal review of all contracts and budgets, patient recruitment, and ultimately being the point of contact to confirm patient-by-patient billing compliance processes are implemented and followed through communication with Envision’s multiple billing platforms.
Clare Grace, PhD
Vice President Site and Patient Access
Syneos Health
Clare brings nearly two decades of strategic global leadership expertise to her role, including a unique blend of academic, pharmaceutical, biotech and CRO industry experience. She joined INC Research from PPD where she held several senior leadership roles, including most recently Senior Direct and Head of Global Site Intelligence. Clare holds a PhD in Molecular Oncology from the University of Manchester Institute of Science and Technology and a bachelor’s degree in applied biochemistry from Liverpool John Moores University.
Scott Gray
Scott Gray is an innovative leader in the world of corporate meetings and clinical trial performance improvement. Founded in 1994 as a full-service meeting planning company (Gray Consulting, Inc.), Scott changed the direction of the company after a 2013 client meeting to discuss patients’ challenges with logistics for participation in global clinical trials. The Clincierge® concept was born as a means to improve recruitment & retention and contain timelines & budgets in clinical trials through customized patient-centric support services. In addition to his role as CEO of Clincierge, Scott has been Chairman of the World Orphan Drug Congress, sits on the Board of Governors at Valley Youth House in Philadelphia, and represents Clincierge as a Global Impact Partner with SCRS.
Rick Greenfield, BBA-IS
Realtime Software Solutions
Rick Greenfield is the CEO of RealTime Software Solutions, a leading Clinical Trial Management Systems provider. Rick also co-owned and managed one of the largest multi-specialty research sites in the US for nearly thirteen years where RealTime-CTMS was first created and implemented to streamline site operations for all staff and processes. Today, RealTime is the only CTMS vendor that can offer the industry-leading site SOMS (Site Operations Management System) that fully integrates CTMS, TEXT, PAY, eDOCS and eSOURCE into a single platform.
Michael Griffith
Intend Research
Michael Griffith is married to Dr. Lisa Connery Griffith and he acts as the Managing Director of Intend Research. Michael received his undergraduate degree from the University of Denver. To pay for college, Michael worked in Denver as an EMT-Paramedic. He earned a Juris Doctor degree from Pepperdine School of Law. He practiced law for over 25 years specializing in contract negotiation and civil litigation.
Joseph Grosso, BS, MBA
Clinical Development Consultant
Eli Lilly & Company
Clinical operations professional working for Eli Lilly & Company. Over 10 years experience working in clinical research holding various positions such CRA, trial manager, CRA manager prior to my current position as Clinical Development Consultant.
Karin Gulbrandsen
Sr. Director, U.S. Head, Global Clinical Operations
Janssen, The Pharmaceutical Companies of J&J
Karin has worked at Janssen Pharmaceuticals since March 2015 as the U.S. Head for Global Clinical Operations with focus on quality delivery of Late Development and Medical Affairs studies. She has 22 years of experience in the pharmaceutical business which includes experience in training, building capabilities, and leading global initiatives. She oversees the U.S. operational country teams managing programs across multiple therapeutic areas such as Neuroscience, Oncology, Immunology, CV, Metabolism, Infectious Disease and Vaccines. 
Sam Haiden, MA
Executive Director
Sam Haiden graduated from the University of California, Irvine with a master’s degree in European history. After transitioning to the public sector, he has worked actively in marketing, sales, and business strategy. For the last 4 years, Sam has worked on the leadership team at StudyKIK, seeking to help improve the lives of patients and cutdown the timelines of clinical trials. When not working, Sam is typically found outdoors.

Beth Harper, BS, MBA
Workforce Innovation Officer
Beth is the President of Clinical Performance Partners, Inc. a consulting firm specializing in enrollment and site performance optimization. She is also serving as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades.   
Larissa Harrison
Regional Director
Larissa Harrison is an experienced clinical research professional with over 10 years of industry experience. Larissa currently serves as the Regional Director of Qcare, an IQVIA company, where she provides operational oversite of Qcare’s Midwest sites as well as support in the growth and development of Qcare’s site network. Prior to joining IQVIA, Larissa served as the Director of Site Development for the largest, global Site Management Organization where she managed all aspects of establishing new research sites, training and mentoring new staff and establishing strategic partnerships and initiatives. Early in her career, she has also held roles as a Clinical Research Coordinator and Site Manager focusing on multiple therapeutic areas including endocrinology, immunology/vaccine, cardiology, and pain management. In her free time, Larissa is an avid world traveler and outdoor enthusiast enjoying activities such as hiking, sailing and snowboarding. Larissa holds a Bachelor’s Degree in Psychology from Arizona State University.
Seneca Harrison
Quality Clinical Research
Seneca Harrison is CEO of Quality Clinical Research in Omaha, NE, a multi-specialty research site. He is responsible for business development, budget negotiations, overall administration, and sourcing over 300 trials.
Ryan Haynes, MT (ASCP)
Director, Clinical Research
As Director of Clinical Research for CSSi, Ryan is responsible for client consultation, operations development and oversight of the project management activities. Previously, Ryan was the director of CSSi’s Site Management Solutions (SMS) division, assisting with the clinical operations process for sponsors, CROs and sites, in which he was responsible for clinical trial design, site and patient feasibility, study startup, and operations management. Ryan has been involved in over 200 study clinical programs in over 40 therapeutic areas while at CSSi. Ryan brings over 19 years of experience in the pharmaceutical industry with expertise in project management, drug development (discovery through commercialization), outsourcing, investigator relationships, and patient recruitment. Prior to joining CSSi, he ran the regulatory and clinical operations programs for a biotechnology company whose focus was on oncology, inflammatory diseases and women’s health.

Melissa (Missy) Heidelberg,
Principal Realization Project Manager
Product Development Industry Collaborations
Missy represents Genentech and Roche on industry collaborations including TransCelerate BioPharma, Inc., Clinical Trials Transformation Initiative (CTTI), Society for Clinical Research Sites (SCRS), Innovative Medicines Initiative (IMI) and with the Multi-Regional Clinical Trials Bioethics Collaborative. She is currently pursuing a Masters Degree in Bioethics at Columbia University.
Rhonda Henry, BSN
VP of Strategic Site Collaboration and Patient Centricity
PPD, Inc.
As vice president of site collaborations and patient centricity, Rhonda Henry leads PPD’s commitment to building strategic relationships with physicians and patients across the world with the objective to bring more treatment options to more patients. As a breast cancer survivor, Rhonda understands the importance of involving patients in the clinical trial process, while also making potentially life-changing therapies more accessible to patients where they live. Rhonda joined PPD in 1991 as a clinical research associate. During her time with the company, she also held a variety of roles with increasing responsibilities on both the operational, as well as the commercial side of the business. Rhonda has a bachelor’s degree in nursing from the University of North Carolina Wilmington. She completed Lean Six Sigma training from Vanderbilt University and was a member of the first graduating class of PPD’s Global Leadership Program. Rhonda now serves as a mentor for PPD’s Global Leadership Program. Rhonda is a member of the Association of Strategic Alliance Professionals, the Oncology Nursing Society and an alumni of Women in Leadership. She also participates in the AVOCA’s Leadership Advisory Board for Patient Engagement.
Lisa Hoagland, BSN, CCRC
Executive Director
Rapid Medical Research, Inc.
Lisa Hoagland has served as Executive Director of Rapid Medical Research, Inc (RMR) since 2013 and has been on staff since 1998. Lisa is responsible for oversight of the daily operations and clinical research staff at RMR as well as providing strategic direction and leadership for the site. Before entering management with RMR, Lisa developed her skills as a Clinical Research Assistant, Research Coordinator and Site Director throughout her 20 year career in research. Lisa earned a Bachelor of Science in Nursing (BSN) degree from Ursuline College. She also earned certification as a Clinical Research Coordinator (CCRC) from the Association of Clinical Research Professionals.
Robert J. Howal, BS
Site Partnership Manager
Robert has a background in ICU nursing and 21 years of clinical research experience. He has worked at both sponsor and CRO companies in Pharma, Biotech, and Medical Device on industry and government trials as a monitor, safety specialist, trainer, study manager, clinical leader, and now, as a site partnership manager. Robert has a passion for improving the overall life-experience via constant curiosity, learning, and conscientious application.
Chris Hoyle, MBA
Executive Director
Elite Research Network LLC
Mr. Hoyle entered clinical research in 2001 after obtaining his MBA. While working at a dedicated research site, he was involved in all aspects of investigator site management, including patient recruitment, budgets and contracts, and business development. In 2004, he founded Elite Research Network where he manages business development, feasibility, and strategy. He earned his BS in Zoology from NC State University and his MBA from UNC – Wilmington.
Jeannie Inge
Executive Director of Site Commercial Solutions
PRA Health Sciences
Jeannie Inge is Executive Director of Site Commercial Solutions, PRA's business unit dedicated to the commercial relationship with sites.    For more than 18 years she had lead the implementation of key strategic projects in IT, Quality and Process Management, and Compliance.  This includes the creation of PRA's global, to Fair Market Value Budget development, Clinical Trial Agreement negotiation, Grant Payments, Reporting for project management, financial and regulatory compliance,and system design and delivery.   In addition to leading the SCS Business Unit, she also Chairs PRA's Enterprise Data Governance Committee which supported the implementation of EUGDPR compliance and Data Integrity.   Prior to working at PRA, she was at the University of Virginia where she worked on systems management and compliance with the University of Virginia Medical Center,  Procurement, and QA.  She received her BS, MS and MS in Information Systems from the University of Virginia.

Anne Marie L. Inglis, PhD
Head of US Clinical Operations
Anne Marie Inglis began her career over 20 years ago at GSK (formally SmithKline Beecham) as a Clinical Research Scientist, designing protocols and preparing Clinical Trial Reports for Phase I and Phase II Proof of Concept Studies. She moved into GSK Vaccines in 2006, where she became more involved in in-country clinical operations, managing teams of local study managers, local clinical trial supplies specialists, site selection specialists and clinical monitors. She moved into her current position, Head of US Clinical Operations for GSK Pharmaceuticals in 2015, and is accountable for execution of all GSK US studies. As part of her current role she is interested in developing strong working relationships with clinical trial sites to improve study start up and delivery of recruitment to plan. She received her PhD in Pharmacology at the University of Pennsylvania.

Leslie Ives
Associate Director, Patient Recruitment Strategy Group
Leslie has been working for PAREXEL since 2016 in multiple different roles ranging from Proposal Strategist and Project Manager to Associate Director. She has 13 years of clinical trial experience and 15 years of patient recruitment experience. She has provided oversight and supported recruitment and retention for over 250 programs in the last 3 years. She also has extensive experience in patient centricity and new innovations. Some of Leslie's therapeutic experience lies in Onychomycosis, HPV, Type II Diabetes, Lupus Nephritis, Prodromal AD, Uterine Fibroids, PPMS, Hemophilia B, Neuromyelitis Optica and Macular Degeneration.She has managed global, multi-site Phase II/II clinical trials across a broad range of therapeutic areas. This included a multi-site, Phase II rheumatoid arthritis study and Phase III study for depression. Leslie holds a Bachelor;s degree in Biology and English from Meredith College in Raleigh, NC.
Denise Johnson Sura
Senior Engagement, Site Engagement
Eli Lilly and Company
Denise Johnson Sura joined Eli Lilly and Company in 2004 as a Clinical Research Associate and has since held a variety of positions across the organization supporting the global development of medicines. Presently, Denise leads the global organization responsible for the identification, qualification, support and collaboration with clinical trial sites participating in Lilly studies. Denise and her team recognize the value of site and patient feedback in the design of efficient and effective studies, ultimately leading to improved clinical trial experiences.
Len Jokubaitis MD
Clin Ops Head, Americas Med Affairs Ops
Jansssen Research and Development
Leonard (Len) Jokubaitis is a physician with over 29 years’ experience within the Pharmaceutical industry. He is currently Clinical Operations Head, Medical Affairs Operations for the Americas region within the Global Clinical development Operations Group of Janssen R&D. This position oversees the deployment and execution of all research programs sponsored by Johnson & Johnson’s Pharma Medical Affairs organizations throughout North and South America. The group manages a trial portfolio of interventional and non-interventional studies, along with support of Investigator initiated studies and Expanded Access/Compassionate use programs. Previously, Len was Vice President, Data Generation for Ortho McNeil-Janssen Scientific Affairs; Executive Director of the Medical Affairs GI franchise; and Group Director of the Medical Development group within the Janssen Research Foundation. At Sandoz Pharmaceuticals from 1989 - 1996, Len was an Executive Director of Medical Services and previously Director of Clinical Research in the cardiovascular and diabetes therapeutic area.
Ryan Jones, MBA
Ryan is CEO of Florence Healthcare. Florence advances clinical research through software. The Florence eBinder Suite replaces paper investigator site files, trial master files and source binders with a shared platform between trial sites and sponsors. Before joining Florence, Ryan was president of Pubget (acquired by the Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals and research institutions worldwide. Ryan joined Pubget from Microsoft’s enterprise search group, where he helped the web’s largest sites make information understandable and accessible with search technology. Before Microsoft, Ryan analyzed enterprise software investments at Commonwealth Capital Ventures and built technology market strategies at the Yankee Group. A frequent speaker, he has been quoted by the New York Times, Wall Street Journal, and the Harvard Business School Press.

Ryan has an AB from Dartmouth College and an MBA from UC Berkeley, where he was a Price Fellow. He is an avid cyclist, pilot and a terrible golfer.
Brigid Jordan
Senior Manager
PRA Health Services
Brigid Jordan is a Senior Manager of PRA Health Sciences Site Commercial Solutions business unit which is dedicated to the commercial relationship with sites. Brigid is responsible for the creation of global Fair Market Value budgets, in both the proposals and post-award stages, as well as contract management in the Americas.

Sandra Jovanovic
Director of Talent Innovation
Sandra leads the division within Medix responsible for developing, delivering and driving innovative strategies. She uses her previous experience from higher education and international marketing to develop programs and workforce solutions such as Medix Match® and Medix Intelligence℠ to better align the network of talent and clients Medix partners with.
Janusz Kabata, MD, PhD, MBA
Janusz Kabata MD, PhD, MBA is a successful entrepreneurial healthcare professional with 40 years of academic and executive experience in public and private healthcare sectors in Europe, and 30 years of experience in various aspects of clinical trial management, including managing central laboratory services and home-care services for global clinical trials. He is co-founder of GP4research that develops European GP Practice-Based Research Network. Prior to GP4research, he co-founded GlobalCare Clinical Trials Ltd, and developed the network of home care service providers in Europe and Asia. He established Synevo Central Lab. He is a specialist in public health and laboratory medicine. He was Associate Professor at Gdansk Medical University, Poland and Visiting Professor at Hematology Department at Basel University, Switzerland. He has been an invited speaker at several clinical research industry conferences and scientific meetings in laboratory medicine and hematology. With his wife, he manages GP practice in Gdańsk, Poland.
Hassan Kadhim, MS
Senior Associate Director, Head IT Clinical Trial Planning and Management
Boehringer Ingelheim
Hassan Kadhim is presently Senior Associate Director and Head of IT in the Clinical Trial Planning & Management department at Boehringer Ingelheim (Ridgefield, CT, USA). He earned a Bachelor of Sciences degree in bioinformatics and a Master of Science degree in pharmaceutical sciences, majoring in clinical drug development.  Hassan has more than a decade of informatics and digital technology experience in the pharmaceutical/biotechnology industry. He continues to successfully leverage his knowledge of drug discovery, clinical operations, and informatics by driving forward the vision of patient centricity and digital health at Boehringer Ingelheim, promoting the remote clinical trial model, and implementing innovative digital health technologies in clinical trials. Hassan is passionate about transforming the clinical research arena and improving access and experience for patients within a digital world through use of technologies and patient-centric clinical trials. Hassan is also active in the pre-competitive space with contributions on the Transcelerate BioPharma consortium and the Clinical Trials Transformation Initiative (CTTI) Mobile Clinical Trials program.
Nolan K. Kapp, CPA, CGMA, CM&AA, CVA
Managing Director
Allston Advisory Group LLC
Nolan is a Managing Director at Allston Advisory Group, LLC, and is involved in all aspects of the firm’s business; more specifically, he is responsible for executing a variety of M&A advisory, investment banking, consulting, and valuation assignments. Prior to joining the firm, Nolan spent several years as an analyst in the health care industry where he reviewed, negotiated, and optimized contracts on behalf of a hospital network. Previously, he worked at a regional public accounting firm assisting closely-held businesses and professional practices. In 2015, Nolan was selected by the National Association of Certified Valuators and Analysts as a 40 under Forty honoree. Honorees from across the US were vetted against their peers, and must have exhibited excellence, superior quality, and the spirit of pioneering in the performance of valuations and other related advisory services.

Brian Kay
Managing Director
Allston Advisory Group LLC
As Executive Director of Operations at StudyKIK, Brian oversees all aspects of StudyKIK’s central and site operations, working directly with Sponsors, CROs, and sites to create highly effective patient recruitment campaigns that deliver unequivocal results. Utilizing his background and experience in directing and managing multi-faceted campaigns, Brian is dedicated to providing superior results in the pharmaceutical industry.
Victoria Kenny
Business Development Executive
Splash Clinical (Teuteberg Inc.)
Victoria Kenny is a Business Development Executive for Splash Clinical, an innovative patient recruitment firm that has pioneered the use of digital & social media to recruit patients for clinical trials. Ms. Kenny helps develop and foster partnerships with Sponsors, CROs and Research Sites.   Ms. Kenny has been with Splash for more than three years and is involved in encouraging the company’s focus on patient recruitment. Ms. Kenny has a broad range of experience in various therapeutic areas and has the knowledge to assist with any patient recruitment needs.
Jackie Kent
SVP Head of Product
Jackie serves as SVP, head of product at Medidata. She has over 30 years of organizational development experience, including clinical development process, complex IT strategies, and system solutions. Prior to joining Medidata, Jackie spent 28 years at Eli Lilly, starting with technical IT and moving into leadership roles. She developed a comprehensive knowledge of information technology, clinical trial design & execution, as well as CT supply planning. Jackie also had accountability for the IT systems that supported these teams, including the Clinical Trial MRP system (SAP) and the Lilly IRT system. Jackie is a member of the Society for Clinical Research Sites (SCRS) Leadership Council, where she previously represented pharma companies, and now continues representing Medidata. Jackie received her B.S. in Computer Science from Butler University.
Jessica W, King, CCRA
Senior Manager, Site Partnerships
Covance, Inc.
Jessica King is a Senior Manager in the Site Partnerships Division at Covance. Her 22 years of experience in the clinical research industry has provided her with a strong expertise in study execution, leadership, effective communication and a comprehensive understanding of what it takes to remain innovative and successful in the face of a constantly changing research environment. Prior to joining the Site Partnerships team at Covance, she has worked in several roles over the years, including study monitoring, global project management and trial site and sponsor relations. Although she has worked across multiple therapeutic areas, Jessica’s passion lies in the field of oncology which has been her focus for the last 13 years.
Irfan Khan, MD, FACC, FHRS
Circuit Clinical
Dr. Irfan Khan is a board-certified cardiologist, principal investigator and CEO of Circuit Clinical, an Integrated Research Organization (IRO). He has led the successful development of multiple eClinical products. His passion for the intersection of patient engagement and technology has led to numerous national speaking engagements, including TEDx. 

Kristin Kinlaw
Director of Communications
PMG Research
Kristin Kinlaw is responsible for the patient recruitment, engagement, and corporate communications teams at PMG Research, an integrated network of 14 clinical research sites. Kristin has over 10 years of experience in patient engagement and clinical research communications, creating effective recruitment strategies at both the central study and site levels. She has developed innovative programs including The Patient Voice, a feedback platform offering patient insights for clinical trial protocol development, feasibility, recruitment, and more. Kristin believes that building patient relationships within our communities is crucial to helping sites connect patients with the right trials, and supporting industry partners in bringing life-saving treatments to patients more quickly. 
Emily Knisely
Compliance Manager
East Coast Institute for Research
As a former study coordinator, Emily Knisely, Compliance Manager at East Coast Institute for Research (ECIR), brings a unique perspective to the world of clinical research compliance. ECIR is committed to providing innovative, state of the art care to patients in the community by facilitating clinical studies in a variety of healthcare disciplines. Emily manages all aspects of compliance and quality at ECIR to aid in the company’s commitment to providing Sponsors and CROs with high quality data. By creating and implementing a comprehensive quality management plan, Emily assists the dedicated staff of healthcare professionals in maintaining a constant state of audit preparedness.
Leisel Koerber
Senior Vice President, Operations/EOS Integrator
Clinical Trials of Texas, Inc.
Barry Lake
Devana Solutions
As CEO of Devana Solutions®, Mr. Lake is responsible for overall strategic vision and execution (www.devanasolutions.com). Devana Solutions® IGNITE FOR SITES is the leading cloud-based operations and data analytics platform for clinical research sites, site networks, Academic Medical Centers and Health Systems. By having all functional teams on a common platform from trial lead through completion means better accountability and process efficiency allowing site leadership to leverage data analytics to drive operational improvements. IGNITE FOR SITES technology automatically captures key site timing and performance metrics data which can then be displayed and reported to Sponsor and CRO clients validating a site’s performance reliability and leading to more trial awards. Devana Solutions® transformative MATCH PERFORMANCE technology works in tandem with IGNITE FOR SITES. The companion technologies allow Sponsors and CROs and their research site, site network, Academic Research Center or Health System partners to achieve an unprecedented level of operational alignment through performance data transparency. Specifically, the technology allows these research stakeholders to synchronize and share not just historical site metrics data but, also, real-time performance metrics on currently running trials laying the foundation for a true collaboration between investigative sites and industry Sponsors and their CROs and a drastic reduction in clinical trial cycle time and costs. As a result, new therapies to benefit patients can be delivered faster and more cost effectively. 
Nathan Laney, MD
Regional Medical Scientist
Novo Nordisk, Inc.
Nathan Laney, MD, is a Regional Medical Scientist for Novo Nordisk in North America. Dr. Laney and his team support the Field Medical Affairs team, serving as not only as educational resources in the therapeutic area of Diabetes, but also as educational support for clinical trials and investigator initiated studies in the therapeutic area of Diabetes and Obesity. Dr. Laney graduated from the University of Missouri – Kansas City School of Medicine. He went on to complete an Internal Medicine residency, and a fellowship in Adult Endocrinology, Diabetes, and Metabolism. Prior to joining Novo Nordisk, he worked in a clinical endocrinology practice in Kansas City, MO.
Michelle LaPage
Director of Business Development
Aventiv Research, Inc.
Michelle has been blessed to hold various positions in clinical research since 1989 for a variety of sites around the country.  Over the past 10 years, she has exclusively worked in SITE Business Development positions.  Serving as Director of Business Development. for Aventiv Research since April 2015, her primary role is to identify and develop new clinical trial opportunities for their 5 sites (3 in Ohio, 1 in Arizona, 1 in PA, 1 in MD) in a variety of therapeutic areas.  She establishes and maintains client relationships to quickly share information on our sites/PIs.  She is proud to work with Dr. Samir Arora and Aventiv Research team! 
Melina Lolic. MD, MS
Lead Medical Officer
Dr. Lolic joined FDA in 2008 as a clinical reviewer in the Office of New Drugs. She was involved in approvals of new drugs, improvement of post-marketing drug safety databases, and regulatory training for medical officers. Dr. Lolic is currently leading the Drug Trials Snapshot initiative. Her work focuses on demographics of clinical trial participants and variability in drug response among demographic subgroups. Dr. Lolic received her master’s and medical degrees from University of Belgrade, Yugoslavia. She completed a research fellowship at George Washington University and an internal medicine residency at Greater Baltimore Medical Center, where she served as Chief resident. Dr. Lolic is a board-certified internist and prior to joining FDA, she was practicing hospitalist at University of Maryland St. Joseph Medical Center in Towson, Maryland.
Matt Lowery, ACRP-CP, CCRC
In his 11 years in clinical research, Matt has worked on both the site and sponsor sides of the industry.  He has found his niche in contract and budget negotiation and has held the CCRC certification through ACRP since 2013 and recently obtained his ACRP-CP certification as well. 
J. Daniel Mallory IV, Esq.
Head, Regulatory and Contracts
Qcare Site Services, Inc.
A native of South Carolina, Daniel studied Psychology at The Citadel, and participated in research, presenting twice at annual conventions of the South Eastern Psychological Association. Upon graduation, Daniel attended the University of South Carolina School of Law where he earned his J.D., and became a practicing attorney in 2011. In 2014 Daniel moved to North Carolina’s Research Triangle to work for Quintiles where he specialized in Start Up with major Academic Institutions. In this position, Daniel learned many of the concerns of Sites in the budgeting and Start Up processes, and worked closely with Sites to educate Sponsors on their particular circumstances and needs. In March of 2018, Daniel joined Qcare to lead the Regulatory and Contract group, to take on the next step in addressing the challenges Sites face as they navigate towards Initiation into studies.
Kaitlin Malone
Development Feasibility Manager
Kaitlin Malone has been with Amgen over a decade and is has held several roles within Amgen’s study start up team. Her current role is a Development Fesasibility Manager, within Amgen’s Global Study Operations team, responsible for country operational landscaping as well as site selection for studies. She also has been a clinical trial oversight manager with oversight of the clinical trial contracts, budgets, and payments. While she is located at Amgen’s headquarters in Thousand Oaks, CA, Kaitlin also supports global teams with the development of training tools and support resource to ensure consistency and quality. She has enjoyed partnering with SCRS over the years, knowing that Amgen’s partnerships with sites is critical for drug development for patients. Malone holds a bachelor’s degree in law and sociology from the University of California, Santa Barbara.
Ana Marquez, MSF Founder and CEO
Marquez ClinicalSite Partners, LLC
Ana T. Marquez, is the founder and CEO of Marquez Clinical Site Partners, LLC, a network of rapidly growing investigative sites in the USA. Prior to entering the research world, she worked as a Practice Administrator, and Accountant for several years. Ana then worked as the Chief Operating Officer and CFO for a highly successful clinical research site in Florida, until she opened up her own Company and began building new research teams in various therapeutic indications. Because she’s been exposed to the coordinating, the financial, and administrative aspects of conducting a clinical trial, she has an overall understanding of the challenges facing sites today. Ana has consulted for sites across the country, helping them improve their financial operations, negotiating clinical trial budgets, establishing sound accounts receivables processes, preparing for FDA inspections, and implementing quality control programs. Additionally, she’s very passionate about helping sites understand the importance of having a solid grasp on financial operations, and the impact that negotiating sound budgets has on their bottom line.
Ana earned a Masters of Science degree in Finance from Florida International University. Currently, she serves as Chairman for DIA’s SIAC’s Committee for Investigative Sites globally, and works closely with SCRS as Chairman of the Membership Committee. With a strong background in finance and accounting, she has spent a number of years negotiating clinical trial agreements and budgets in various therapeutic indications for a number of sites. Throughout the years, she’s served as a Clinical Research Coordinator, Research Director, Chief Operating Officer, CFO, Site Owner, as well as an industry speaker and moderator at clinical research conferences.
David Marquez, BS Regional Project Manager & Site Director
Clinical Site Partners, LLC & Clincial Trials of Florida, LLC
David Marquez, BS, is the Regional Project Manager of Clinical Site Partners, LLC and Site Director for Clinical Trials of Florida, LLC. He is an experienced Clinical Research Coordinator, Regulatory Specialist, Recruiter, and CTMS Administrator for the network of research sites in the State of Florida. From the institutional level, David has experience coordinating protocols, building and training teams, auditing trials for quality assurance which includes protocol compliance, developing recruitment strategies for subject enrollment/retention, creating site processes and implementing technology such as e-regulatory and e-source.
Additionally, David has expertise in conducting Phase I - IV clinical trials in the following indications such as cardiology, family medicine, gastroenterology, respiratory, sleep, and CNS trials. He has assisted with site start-up and expansion, CTMS application, and new investigator training. David holds a Bachelor’s of Science degree in Biology from Florida International University.
Effie Manos
Associate Director - Neuroscience, Global Clinical Operations
Janssen Research & Development
Effie Manos has been in clinical research for almost 20 years. She has held various positions in data management, study coordination, quality assurance, site management, training, operations management and leadership. Since 2001, Effie has been at Janssen- the pharmaceutical division of Johnson & Johnson. She is an Associate Director in Global Clinical Operations for Neuroscience. She currently leads a successful team in optimizing operations to bring new therapies to market. Effie is also the Diversity in Clinical Trials Lead for Janssen where she and her team work on developing partnerships and raising awareness in disparities associated with Clinical research. She is an avid yogi and resides in Portland Oregon with her 2 children and cinematographer husband where they fully enjoy all the Northwest has to offer including hiking, biking, and exploring.
Sheila Marsh, MPH
Project Lead/Sr. Clinical Research Associate
Sheila Marsh is a Sr. Clinical Research Associate at GlaxoSmithKline with 20+ years’ experience in vaccines and drug development, global clinical operations, and project management at sponsor organizations in various therapeutic areas. She is currently Project Lead to identify and recruit potential investigators and sites to support maternal immunization research. Sheila holds a Master of Public Health from Emory University. She completed her undergraduate studies in Biology and Spanish Literature at Akron University.

Jonathan Seth Mayberry, BA, CCRC

Clinical Research Coordinator
Chattanogga Medical Research, LLC
Jonathan is an ACRP Certified Clinical Research Coordinator who has spent the last several years working for Chattanooga Medical Research, LLC, a multi-specialty research site in Chattanooga, TN. He also works as a freelance writer in a variety of areas, including copywriting, medical writing, and business correspondence. Jonathan holds a Bachelor’s degree in Biology, with a concentration in Health Professions. He has gained experience in both inpatient and outpatient care across multiple indications including women’s health, endocrinology, CNS, pain management, vaccines, and infectious diseases, among others. Jonathan is passionate about his career in clinical research and is always looking forward to the next challenge, new indication, or opportunity for growth. When he is not at work, he enjoys traveling, working with his wife on flipping their house, practicing jiu jitsu, and floating down the Tennessee River on his homemade raft.
Megan McBride, MPH
Clinical Innovation Leader
Janssen, Pharmaceutical Companies of J&J
Megan McBride, Associate Director, Janssen Clinical Innovation (JCI) has 20 years of global trials experience in the pharmaceutical industry and non-profit/NGO organizations. Megan is a clinical trials enthusiast focused on accelerating innovation in the trial process-before, during and after- for all stakeholders-especially participants! Her current role is improving the patient experience via a global trial community to connect patients in Janssen sponsored trials through a secure, online platform with their individual trial data, study information and feedback surveys and more! Megan is also an active member of the Patient Data Access Initiative cross pharma collaborative. Having worked on building partnerships with patient communities to support trials conducted in Africa and India, Megan provides a robust perspective on innovation in trials. With a strong passion for innovation and a can-do spirit, Megan has implemented new approaches when others said it can’t be done! Megan holds a Master’s degree in Public Health.
Jason Methia, MS
VP, Site Strategy
Veeva Systems
Jason is accountable for Veeva’s overall site technology strategy. Prior to joining Veeva in 2013, Jason held a variety of roles within clinical development at the Dana Farber Cancer Institute, Wyeth Research and Vertex Pharmaceuticals. Jason received his M.S. in drug development and regulatory affairs from Northeastern University and his B.A. in psychology from the University of Vermont.
Dan Milam
Vice President Global Engagement
With over twenty years of experience working in the pharmaceutical, CRO, and site sectors, Dan has gained a wide perspective and understanding of the needs of the industry as a whole that aid to facilitate and build strong alliances. His focus is on expanding SCRS’ global footprint and the inclusion of all industry stakeholders in SCRS initiatives with the goal to foster sustainability for clinical research sites.
Andrew J (AJ) Mills
Executive Director, Strategy
Firecrest (ICON)
AJ has worked in the clinical trial industry for the last 15 years, focusing on driving performance within clinical trials. For the last two years AJ has led the strategy for the FIRECREST division of ICON PLC. In this role, AJ works closely with Sites and Sponsors to reduce the trial burden on sites and patients through the use of technology.
Mohammed Ali Millwala, MBA, CPA
DM Clinical Research
Founder and CEO of DM Clinical Research, Mohammad has been a natural entrepreneur in the healthcare sector since 2002. DM Clinical Research is an industry leading, multi-therapetic site network that has successfully conducted over 845 trials. DM Clinical Research comprises of 13 sites in Chicago, Houston, San Antonio and Alexandria.
Paul Mitchel
VP Global Business Strategy
iPatient Axis
With over 20 years of experience in marketing across a variety of industries, Paul leverages his expertise to lead patient recruitment and retention efforts. Presently, he oversees the global product development and business strategy at iPatientAxis, a new technology company driving patient quality and qualification through real world evidence. Prior to this Paul was the Senior Director of New Markets and Innovation at Acurian, developing its global capability and implementing new approaches to patient recruitment. Extensive experience engaging consumers in large sectors including FMCG, energy, automotive and retail has positioned Paul to apply his leadership and marketing skills to clinical trials.
Joy Mowery, RN, MS
Director of Clinical Site Management
Joy Mowery brings with her over 28 years of clinical research experience including academic clinical research and pharmaceutical drug development. She is a Registered Nurse and holds a Master of Science degree in Pharmaceutical Outcomes from the University of Florida. As a Director of Clinical Site Management at Pfizer, she is passionate about partnering with investigator sites to safeguard the highest quality of clinical trial execution. Together we work on behalf of people in need that are waiting for new medicines that can change their lives.This can only happen by thinking globally, acting locally and holding the clinical trial participants and their families at the heart of what we do.
Raymond Nomizu
Clinical Research IO
Raymond Nomizu is co-founder of Clinical Research IO (CRIO), the industry leading eSource system for research sites. CRIO enables sites to streamline workflows and improve compliance, and is based on Raymond’s experience as the owner and manager of a dedicated research site. Raymond spent the bulk of his career as a management consultant, first with The Boston Consulting Group and then as an independent. He has a JD from Harvard University. 
Dan O'Connell
Director, Strategic Monitoring
Medidata Solutions
Dan has more than 20 years of Clinical Operations experience from across both Pharma and CROs. After spending 10 years in the industry as a CRA, Dan took a Monitoring Systems role at Sanofi where he managed the CTMS, EDC & eTMF for all US Operations. Later as the Associate Director of Clinical Innovation at INC Research, Dan was responsible for providing customers with “fit for purpose” RBM methodology and technology implementation. Now at Medidata, Dan works with customers to understand their business processes and strategies to develop the best solutions suite to help support their operations and achieve clinical trial success.
Paul O'Donohoe
Scientific Lead, eCOA
Mobile Health at Medidata
Paul O’’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and supports internal teams and Sponsors around the implementation of industry and regulatory best practices in studies using eCOA. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia. Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he lead their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.
Shielia Nagley
Care Partner to Husband with Alzheimer’s Disease
Shielia had a successful career using direct marketing tests to determine most profitable sales. Retiring and looking forward to spending time sailing and traveling, Shielia’s husband, Bill, whom she’s been married to for 32 years, was diagnosed with Alzheimer’s Disease and pancreatic cancer, and 9 years ago, her role as a caregiver began. No stranger to researching from her working days and knowing the limitations of treatments available, they concluded drug trials were their greatest hope. Shielia is a passionate advocate about the importance of research when faced with incurable disease and their ability to extend the quality of life. She herself has participated in research and has recruited several other participants as well as being the medical surrogate for a dear friend with glioblastoma. She is a member of The Brain Dames and has started Memory Mondays, a monthly social event for Caregivers and their loved ones with dementia.
Lance Nickens
The Patient Recruitment Agency
Lance Nickens is the President and founder of The Patient Recruiting Agency™ (TPRA), a full service global patient recruiting and retention organization supporting Investigators, CROs and Sponsors since 1999. Mr. Nickens holds a B.A. degree in marketing from the University of Texas-Austin and has over 20 years of advertising and marketing experience with 19 years specifically in patient outreach campaigns for clinical trials. Since 1999, Mr. Nickens and TPRA have completed over 3,500 recruiting and retention campaigns seeking patient populations for more than 150 different healthy, disease specific, rare and hard-to-reach indications seeking males and female patients of all ages and races in multiple languages and countries. TPRA’s strategic focus is derived from Mr. Nickens’ creative energy, client orientation, drive for accountability and passion for creating and developing unique technological solutions. Mr. Nickens’ commitment and hands-on approach to developing unique and efficient solutions to patient recruitment and retention challenges has strategically aligned TPRA as an integral benchmark provider of global recruitment and retention services. 
Petros Okubagzi
Director of Cardiovascular Research
MedStar Health
Dr. Petros Okubagzi, Director of Cardiovascular Research Programs at MedStar Health, has been a leader in the Medstar Cardiovascular Research Network and administers a multimillion dollar research enterprise that includes clinical trials, CRO, Corelabs and animal lab across a 10 hospital Medstar health system. He has over 20 years of experience in clinical research.

Raffaella Olson, BA
Associate Director, Site Partnerships
Raffaella is an Associate Director in Site Partnerships at Covance since November 2017.  She primarily engages with Oncology and Pediatrics sites.  She joined Covance 7 years ago initially as a Senior Project Manager and was then promoted to Project Director to oversee oncology studies.  Prior to joining Covance, Raffaella was a Manager, Clinical Affairs, at Santen, an ophthalmic pharmaceutical company where she led glaucoma studies during her 5-year tenure. Raffaella was also a CRA for 9 years, starting out at Quintiles, moving to Knoll (now Abbott) in Germany, and working her way up at a number of small biotech companies in the Bay Area, mainly in the Oncology space. She has a BA in Molecular and Cell Biology from UC Berkeley. 
Carlos E. Orantes , BS, MBA
Accel Clinical Research Sites
As CEO, Mr. Orantes provides strategic direction and leadership to Accel Clinical Research Sites and its affiliates. Bringing 24 years of experience of CRO and life sciences, his background includes executive/operational management, process re-engineering, compliance and business development. Prior to joining Accel, he was COO of Frontage Laboratories, where he led efforts to expand the company’s capacity of services and managed the business that led to a successful recapitalization. Mr. Orantes was previously CEO of AVANZA Laboratories. He developed the company’s strategy and led the business to a successful asset purchase by the Smithers Group. Prior to AVANZA, he was GM/VP for Bridge Laboratories, a toxicology and immunology testing laboratory where he managed the US operations. Earlier positions included 10 years of operational, quality assurance, process improvement and management roles of increasing responsibility at Covance. Mr. Orantes earned an MBA from Old Dominion University, and a BS in biology from George Washington University. He is Six Sigma Black Belt certified from the Six Sigma Academy.
Casey Orvin
EVP of Business Development
Casey Orvin serves as Executive Vice President of Business Development for Synexus, the country’s largest network of clinical research sites for pharmaceuticals, vaccines and medical devices. Over the past 11 years, Orvin has been instrumental in helping the company grow both organically and through acquisitions of Clinical Research Advantage, Comprehensive Clinical Development, Optimal Clinical Research and the recent merger of Radiant and Synexus. Synexus now offers nearly 200 standardized sites in 14 countries, making it the largest site network in the world, offering pharmaceutical, biotech and CROs experienced and standardized research sites for their studies with a proven record of exceeding enrollment targets in a shorter period of time. They successfully strive to be the “The Patient’s Choice” for clinical research.
Al O. Pacino II
President, Co-Founder
BlueCloud by HealthCarePoint
Mr. Pacino is a USA veteran and a senior executive and with over thirty five years experience in healthcare and clinical research. Co-Founder and current President of BlueCloud by HealthCarePoint.com a leading global network of over 1,400,000 healthcare and clinical research professionals from more than 70,000 organizations focused on providing tools and “real-time” networking technologies that empower members to manage everyday operational, managerial, business and compliance processes by connecting healthcare and clinical research stakeholders. Mr. Pacino is a past member of the Association of Clinical Research Professionals (ACRP) Editorial Advisory Board and past chair of the Central Texas Chapter. He also serves as the VP for Collaborative Network Development at the Alliance for Clinical Research Excellence and Safety (ACRES), and a member of Society for Clinical Research Sites (SCRS) Global Impact Partners among others and actively involved with global standardization programs including standards of care and and is directly involved with government initiatives for standardization of the healthcare and clinical research system. He is also a 12 year head and neck cancer survivor, and a global minority and patient advocate.
Scott Palmese
VP of Site Operations
BTC Network
Scott Palmese is Vice President of Site Network at BTC Network and has been in the research industry for close to 10 years. As a member of the leadership team at BTC Network, Scott oversees the daily operations of the company and provides guidance for the development of new processes and initiatives. Scott specializes in site operations, including business development, financial management, and patient recruitment and engagement.

Marjorie Pazzi, RN, BSN, CCRP
Director of Clinical Research
Center for Neurosciences
After working as a CRC for 6 years in an academic setting, I left and founded the Center for Neurosciences Clinical Research Program in 2009. Our Program focuses on phase 3 Neurology trials as well as early development NeuroOncology studies. We are currently conducting 15 clinical trials with a team of 5 PIs, 2 Coordinators and 1 Research Assistant. In 2010, we wrote a protocol to conduct a phase 2, single-center trial evaluating a combo therapy for glioblastoma, and obtained funding from a leading biotechnology company. 30 subjects were enrolled and 28 completed. Data was presented at the Society for NeuroOncology and published in Cancer Chemotherapy and Pharmacology. This study laid the groundwork for securing other phase 1-2 NeuroOncology trials.
Mitchell Parrish, JD, RAC, CIP
Vice President, Legal & Regulatory Affairs
Mitchell Parrish, JD, RAC, CIP, leads the Kinetiq Legal and Regulatory teams, driving consultation on pressing issues impacting innovative medical research, digital health, and software designed to support clinical trials. Mitchell’s experience includes both in-house and outside counsel roles, having served as a consultant to the National Cancer Institute, regulatory counsel to a large central IRB, and associate attorney at the global law firm K&L Gates. He frequently speaks and writes on FDA, clinical trial, and research site topics, including authorship of chapters on prescription drug labeling and on research in pediatric populations in the Fundamentals of US Regulatory Affairs text book. He is faculty for the Regulatory Affairs Professionals Society (RAPS), a Steering Committee member for Harvard’s Multi-Regional Clinical Trials Center (MRCT), and on the Board of Directors for Life Science Washington.

Donna Percy, RN, BSN, CCRC
Vice President
Sterling Research Group
Donna began her clinical research career in 1982, establishing and coordinating the clinical research division of a large, multispecialty physician group. In 1986, she joined the Lipid Research Division of the University of Cincinnati, serving as Data Manager, Clinical Project Coordinator, and Manager of Clinical Projects. During her 13 year tenure at the University, she was instrumental in the growth and development of clinical projects and the formation of the Center for Cardiovascular Wellness & Clinical Research. In 1999, Ms. Percy co-founded Sterling Research Group, a dedicated clinical research site, with three locations in the Greater Cincinnati area. Over the years, Sterling Research has grown in size and scope of research experience, most recently adding Ophthalmology trials. Donna earned her Bachelor of Science in Nursing from the College of Mount St. Joseph, graduating Summa Cum Laude. She is an active member SCRS, and was one of a small handful of site representatives at the very first Site Solutions Summit. Donna is a proud mother of two adult children, and grandmother to 4-year old Fynleigh. She enjoys running, fitness, and spending time outdoors.
Christopher Petek ,MACPR, CCRC
Research Director
Great Lakes Medical Research, LLC
Christopher attended The Ohio State University where he completed both his undergrad in Neuroscience and Masters in Clinical Research Management and Regulatory Affairs. He has over 6 years of clinical research experience both academic and industry with experience in Phase I to VI trials. He is currently the Research Director for Great Lakes Medical Research and Clinical Director for the The Clinical Trials Network (CTNx).
Rodger P. Pinto PhD
Executive Vice President
Dr. Pinto is the Executive Vice President GEMMS, part of Harris Computer Health Care Division. GEMMS is an information technology company specializing in Electronic Clinical Information Solutions for Cardiovascular programs. The Company founded by Dr. Pinto was launched its product nationally in March 1999. GEMMS is currently in 35 states. Dr. Pinto is a Behavioral Psychologist and holds a postdoctoral degree in Health Psychology from Brown University. He has worked in the Clinical Trials area and was involved as project director and co-investigator in several National Heart Lung and Blood Institute and National Cancer Institute grants. He has authored over 20 published articles in the areas of Health Psychology, Cardiology, and Medical Informatics. He is also a National Speaker in Health Psychology, Health Care Practice Management, and Medical Informatics.
Melissa Poindexter, RN BSN
Advances in Health
Melissa Poindexter, R.N.,BSN, is president of Advances In Health (AIH), established in 1998. AIH is an independent clinical research site, collaborating on Phase I – IV trials, in Houston, Texas. Melissa is a member of the Consortium for Diversity in Clinical Research (CDCR), SCRS, ACRP, DIA, SOCRA and Diversity in Clinical Trials Workstream.
Nazeen Queresh,Bsc (Hons)
Manager, Patient Engagement & Clinical Projects
LMC Manna Research
Nazneen Qureshi is the manager of patient engagement at LMC Manna Research. In this role, she manages study start-up activities, focusing on recruitment and retention strategies. Her objective is to increase the understanding of patient perceptions to improve clinical research processes such as study design, experience, and motivation to participate. Qureshi is the recipient of the SCRS 2017 Site Patient Recruitment Innovation Achievement Award. She holds an HBSc in neuroscience and psychology from the University of Toronto and is completing her MBA at Lazaridis School of Business & Economics.
Marisa Rackley, BS, MHA
PMP - Director
Marisa Rackley is the Director Clinical Development Execution/Head of Site Engagement at Vertex. In this role, she oversees the country and site allocation process for all studies across the portfolio. She serves as lead of the Regional Site Advocate group for North America. Prior to joining Vertex, Marisa was a Director at Merck & Co., where she worked for over 16 years with increasing areas of responsibility within Global Clinical Trial Operations. She has led cross-functional development teams in bone, endocrine, metabolism, cardiovascular and atherosclerosis in end-to-end development.
Deanna S. Radjenovich, JD
Life Sciences Attorney
Axiom Law
Deanna is a transactional attorney based in Chicago, IL with a specialty in life sciences matters, including clinical trials, pharmaceutical development, and related regulations. She is currently practicing with Axiom, providing her expertise to global pharmaceutical companies and research sites. Prior to joining Axiom, Deanna worked as an in-house attorney with AbbVie's research and development legal group
Kimberly Ray
Vice President, Site & Patient Networks
Kimberly Ray has a 30 year career in the healthcare industry, primarily within IQVIA, spanning a variety of roles across the drug development continuum. Over the past seven years, Ms. Ray and her team have focused on enhancing the site and patient experience in clinical trials. As part of these efforts, she led the Site identification and Start-up teams across the Americas and oversaw staff dedicated to site relationships. Currently, she serves in a leadership role in IQVIA’s Site and Patient Networks division, focused on strengthening relationships with both sites and patient groups to enhance their impact on clinical trials. She also leads Qcare, IQVIA’s own site network. She currently serves as IQVIA’s representative on the SCRS Global Impact Partner Board.
Angel Ribo, PA-C, MPAS, AAHIVS
President & CEO
Peninsula Research
Angel I. Ribó PA-C, MPAS, AAHIVS, President and CEO, Principal Investigator/Sub-investigator – Mr. Ribó is a Certified Physician Assistant and is also certified by the American Academy of HIV Medicine as an HIV/AIDS specialist provider. Mr. Ribó is currently one of only two providers in the greater Daytona Beach area that hold this distinguished certification. He is an internationally and nationally sought out bilingual educator and speaker for both professional and lay audiences. Mr. Ribó has served as an investigator in over 90 clinical trials over 15 years. About 40 of these studies have been in the area of HIV/AIDS and the remaining in different multi-therapeutic areas all in Phase II-IV. He currently serves as one of the investigators in all Peninsula Research studies.  
James Riddle, MCSE, CIP, CPIA, CRQM
VP Client Services
Kinetiq (a division of Quorum IRB)
James Riddle is the Vice President of Client Services for Kinetiq, a consulting and technology division of Quorum Review IRB, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Kinetiq worldwide. Mr. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the CTTI Steering Committee; and leader of the ACRES SASI technology domain accreditation team.            

Prior to joining Kinetiq, Mr. Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. In addition, he has served on the board of the Northwest Association for Biomedical Research (NWABR), was an AAHRPP site visitor, and was the Vice President of Operations and Director of Technology at another large central IRB. His expertise includes reengineering operational processes, systems evaluations, development and implementation of technology solutions, integration of technology solutions with operations, and management of large IRB and IACUC systems.  

Mr. Riddle has a bachelor’s degree in accounting with an emphasis in computer science from Western Washington University, College of Business and Economics. 
MaryAnne Rizk, PhD
Rizk Management Consulting
Dr. MaryAnne Rizk has 20+ years of experience transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Dr. Rizk has globally lead Oracle’s and Medidata’s CRO partner market strategy and building eClinical outsourcing alliances for over 90+ organizations from global pharma to emerging biotech/medtech firms. Prior to joining software SaaS firms, MaryAnne found her patient-driven mission working at Merck for nearly a decade, where she led both clinical and commercial outsourced global technology initiatives. Effective in building enterprise clinical outsourcing collaborations, MaryAnne enables organizations to leverage innovative SaaS cloud-based platform technologies to accelerate drug/device development among lifescience stakeholders: Pharma, Emerging Bio, MedTech, CROs.
Debra Rogge, BSN, MSA
Clinical Research Manager
Astra Zeneca Pharmaceuticals
Debra is a registered nurse and hold a Master’s Degree in the Management of Health Care Services. Debra‘s Clinical Research Experience has spanned numerous roles in the past 20 years both in the start-up and maintenance phases of sponsored and investigator sponsored studies. Debra’s current role at AstraZeneca is managing Support Services to include Contract negotiation and budget, Global Trial Master File, CTMS and Regulatrory submission systems and Quality Indicators for the US Site Management and Monitoring organization.
Jeffrey Rosen M.D.
Medical Director
Clinical Research of South Florida
Jeffrey B. Rosen, MD, board certified family physician and also Medical Director and founder of CRSF , has more than 30 years’ experience in clinical research and has conducted over 650 clinical trials in many therapeutic areas. He is a founding member of the Alliance for Multispecialty Research and speaker for several pharmaceutical companies. Dr. Rosen has presented clinical trial results at the European Association for the Study of Diabetes in Vienna, Stockholm, Paris and Berlin and his articles have been published in various medical journals.
Since 2008 Dr. Rosen has been a Medical Director and founder of Community Medical Research, a research site located in Miami, Florida, associated with three community health centers with a large OB/GYN, pediatric and internal medicine patient population.
In addition to engaging in clinical research, Dr. Rosen practices Family Medicine with PrimeCare of Coral Gables, a division of PrimeHealth Physicians, a private group practice adjacent to his research site.
Dr. Rosen is an associate clinical professor of Family Medicine at the University of Miami Miller School of Medicine and at the Florida International University Herbert Wertheim Medical School. He graduated from SUNY Downstate Medical Center in 1979 and is a fellow of the American Academy of Family Physicians and a Diplomat of the American Academy of Family Physicians.
Jason Roth
VP Business Development
Platinum Research Network
Jason Roth leads Platinum Research Network, which consists of seven well-establish Clinical Research Companies including 83 investigators operating in 15 specialties, at over 40 site locations in the United States and Mexico. Jason has over 15 years’ experience in the clinical research industry, supporting business development, feasibility, clinical operations, and patient recruitment activities for academic institutions, hospital systems, private research centers, and CROs. He’s also been a participant!

Archana Sah, MS (Pharm), PMP
Therapeutic Area Leader, Oncology
Archana Sah is a Clinical Research and Development executive with over 22 years end-to-end leadership experience in developing medicines for patients having led and contributed to several FDA/EMEA drug approvals in Immuno-Oncology, Precision therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She is a strategic expert on emerging topics ranging from therapeutic landscape/treatment trends expertise to business strategy, planning and operations. In her current role as the Therapeutic Area Leader, Oncology at Genentech/Roche, she provides therapeutic area expertise, strategic direction and operational leadership for delivery for Phase I-III oncology portfolio trials in the North America region. She is the co-chair of the Oncology Board along with Christine Pierre at the Society for Clinical Research Sites with a mission to cure cancer through efficiency in processes and strength in the partnership between clinical research sites, pharmaceutical companies, and patients.

Fabian Sandoval, MD
CEO & Research Director
Emerson Clinical Research Institute
Dr. Fabian Sandoval, CEO & Research Director, has over 20 years of bench-to-bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine. Before opening the doors to Emerson Clinical Research Institute (ECRI) Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease; and at the NIH's Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center. Dr. Sandoval served as the Supervisory Research Integrity & Compliance Officer in the Army Human Research Protections Office in the Office of the Army Surgeon General. Responsibilities included establishment and oversight of Human Research Protection Programs across Army commands. His input has been instrumental in the review, development, and selection of protocols, in addition to education and training for resident and hospital faculty. Dr. Sandoval holds the following esteemed positions in the following community areas: weekly presenter on his news medical segment “Tu Salud Tu Familia” Telemundo WZDC Washington D.C Leadership Council member, Society for Clinical Research Sites (SCRS) Invited speaker/presenter to multiple pharmaceutical and clinical trial organizations; on the topic of increasing minorities’ engagement, education and participation, in clinical trials. 
Steve Satek, MBA
Vice Chair, Global Site Solutions Summit Planning Committee
President and Founder
Great Lakes Clinical Trials
Steve brings more than 25 years of research experience to Great Lakes Clinical Trials. He began his career as a bench researcher at the Northwestern University Robert H. Lurie Cancer Center and since that time has held senior management positions at the Chicago Center for Clinical Research, Radiant Research, Cognitive Drug Research, Theivon-Wright Consulting Group and Forenap Pharma. Steve has project managed and/or coordinated over 100 trials.
Doug Schantz, BA, MICP
Executive Director, Clinical Operations
Doug Schantz is an Executive Director in Clinical Operations at AstraZeneca. He’s responsible for US site management and monitoring, risk-based quality management implementation and late-phase CRO outsourcing. Prior to joining Astrazeneca in 2015, Doug worked at Pfizer for 17 years and Eli Lilly previously for 8 years. Doug Started his career as a study coordinator at a group of urgent care centers in central New Jersey.  
Kay Scroggins,RN
Clinical Trials of Texas, Inc
I began my career as a registered nurse (RN) and after many years of working in various roles within a hospital setting and conducting nursing research I began my first position as a clinical research coordinator. My life as a business owner and entrepreneur began in 2001 when I founded Clinical Trials of Texas, Inc. (CTT). CTT has grown to be one of the largest stand-alone research sites in the U.S. conducting 100 trials/year. We are recognized for our high quality, meeting enrollment goals and breadth of capabilities- Phase 1-4 in multiple therapeutic areas. My vision for CTT is to continue to grow and to partner with sponsors/CROs to bring new treatments to our community and our world all the while supporting our wonderfully talented CTT staff.
Lillian Ser, JD, MBA
Founder and Managing Attorney
Ser & Associates
Lillian Ser, founder and managing attorney of Ser & Associates, focuses her practice on business and real estate matters. Lillian, armed with a JD, an MBA and years of business experience, provides outside general counsel services to businesses in different arenas, including clinical research sites and physician practices. In addition to her legal practice, Lillian, along with her husband, Dr. John A. Fernandez, a Nephrologist, owns, manages and provides legal counsel to Total Research Group, a new and emerging clinical research site in Miami, Florida.
Oriol Serra Ortiz, MS, MBA
Head of Site Intelligence and Selection
Pfizer Inc
Leader in Strategic Planning and Optimization of R&D Portfolios.

As functional Head for Site Intelligence & Site Selection based in La Jolla, CA., Oriol provides leadership, strategic direction and oversight to effectively deliver country & site feasibility globally. Oriol´s interest in Protocol & Site Optimization started early in his career, and since then, as a change agent, he has led multiple cross-portfolio/cross-functional strategic projects in all the organizations he has worked with, innovating about the engagement of key stakeholders and utilization of data to predictably deliver clinical trials. Oriol holds a Bachelor in Biological Sciences from the Fairleigh Dickinson University, MS Clinical Trials Management from the International University Barcelona and an Executive MBA from University of California San Diego-Rady School of Management.

Jill Smith, MA, CCRC
Assistant Director for Recruitment and Trial Optimization
Global Alzheimer’s Platform Foundation
Jill’s educational background is in Gerontology from the University of South Florida, where she was an instructor for 8 years. She has worked in Alzheimer’s clinical research industry for 13 years, including 10 years directing a university-based research practice. Jill was on the team that created the first ever mobile Alzheimer’s clinical research unit with the University of South Florida and was the lead to operationalize it in various communities in the Tampa Bay area. Jill joined the Global Alzheimer’s Platform Foundation in February 2018 and has been working with Alzheimer’s research centers around the country to enhance their recruitment methods, optimize their clinical trial practices, and build community alliances. She has also produced clinical trial recruitment videos, hosted site networking meetings to share best practices, and works daily with sites, CROs and pharmaceutical sponsors on protocol implementation.
Kelly Smith, CCRP
Senior Solutions Consultant
Bio-Optronics, Inc.
Kelly Smith is a Certified Clinical Research Professional who has been in the research industry since 2007. Kelly joined Bio-Optronics in October 2016. She brought with her a site perspective and an understanding of the problems facing sites today as well as an extensive knowledge of Clinical Conductor CTMS. She currently supports the Sales Executives in terms of proposed configurations and integration solutions. Kelly joined the Sales Team after a year working as an Application Specialist and numerous successful deployments. Prior to joining Bio-Optronics Kelly worked as the CTMS Administrator for PMG Research, a large Investigative Site Network, based out of Winston-Salem, North Carolina. She started as a Regulatory Document Specialist and evolved into a Quality Assurance Coordinator for a small dedicated research site in Charlotte, North Carolina. Kelly currently lives in San Diego, CA and enjoys spending time with her family at the beach, traveling, cooking, and practicing Pilates. 
Matt Smith
Executive Director, Strategic Partnerships
Devana Solutions
As the Executive Director of Strategic Partnerships at Devana Solutions, Matt Smith guides and manages the commercialization of Devana’s innovative technology. Devana Solutions specializes in enterprise SaaS technology for the clinical trial industry designed to improve operational efficiency by using real-time performance metrics, resulting in more awards and better alignment between research sites and Sponsors/CROs. Matt is a seasoned sales manager with 15+ years of leadership and sales channel development experience in the communications, software, and healthcare industries. He is recognized for developing and implementing business growth strategies, with an emphasis on building scalable business processes that can support exponential growth. 
Sandy Smith, RN, MSN, AOCN
Vice President
US Oncology Research
Lead the US Oncology Research site management organization (SMO) for McKesson Specialty Health. The oncology research network consists of approximately 165 locations across the United States and includes early and late phase clinical trials in all therapeutic areas. Simce its inception, the research network has enrolled almost 75,000 subjects on clinical trials. Previous role within McKesson have included leading the integration of new practices into the US Oncology Network, Clinical Services Director, and Director of Clinical Education Services. Prior roles have included managing oncology private practices and oncology service lines within hospital-based cancer programs.

William B. Smith, MD, FACC
William B. Smith, M.D. Professor of Medicine, University of Tennessee Medical Center, Knoxville, TN President, New Orleans Center for Clinical Research and Volunteer Research Group Chief Executive Officer, Alliance for Multispecialty Research. Dr. Smith is the Founder of Volunteer Research Group and New Orleans Center for Clinical Research located within the University of Tennessee Medical Center in Knoxville, Tennessee where he is currently a Professor of Medicine. He is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care Medicine. Dr. Smith is Chief Executive Officer of the Alliance for Multispecialty Research, a clinical research company with 22 locations across the country conducting trials in most clinical areas. He has been involved in over 1875 clinical research trials over the past 35 years including cardiac disease, renal/hepatic disease, early development in healthy volunteer and patients, diabetes, women’s health, obesity, neurology including Alzheimer’s, smoking cessation and numerous variations of PK trials including SAD/MAD, patient-based and complex trials. He has extensive vaccine experience in Phases I through IV studies and is a frequent lecturer and author who publishes extensively in clinical and scientific journals.
Lisa Sorrells
Head of Study Management
Lisa Sorrells is Head of Study Management for the Site Performance and Excellence in Delivery (SPEED) team at GlaxoSmithKline. During her 16½ years with GSK, Lisa has had increasing levels of responsibility, including authoring and implementing the Business Continuity and Crisis Management Plans for the US Local Operating Company. In her current position, Lisa leads a team of professionals whose primary responsibilities are to gather quality country- and site-level feasibility data that is used to determine the appropriateness of US participation in a given study, the probability of meeting global timelines, making site and study participant projections and identifying study risks developing mitigation strategies which assist central study teams in making country-level decisions regarding US participation in upcoming studies. Following country selection, Lisa’s team facilitates the site selection process to ensure the best sites are selected to ensure both site and study success.

Erin South, PharmD
Senior Pharmacist
FDA Office of Women's Health
Erin South is a Senior Pharmacist in FDA’s Office of Women’s Health (OWH).  OWH serves as the principal advisor to the Commissioner on the scientific, ethical, and policy issues relating to women’s health.  She provides expertise on therapeutic product safety, efficacy, and regulation and communicates with stakeholders and agency officials on ways to improve policy and program effectiveness in the areas of women’s health.  Dr. South received her BPharm from Albany College of Pharmacy and Health Sciences and PharmD from Shenandoah University.  Her experience includes clinical and community pharmacy practice and management.  Before joining OWH, she spent three years in FDA’s Division of Risk Management, focusing on REMS for drug-related safety issues.  In addition to her work at FDA, she continues community practice in a part time capacity, to serve her patients and stay current in today’s continuously evolving environment of pharmaceutical care. 
Sean Stanton
President & CEO
Sean co-founded of Compass Research, a leading U.S. clinical research site network acquired by Bioclinica in July 2016. Sean has nearly 25 years of experience managing clinical research studies. Early in his career he held numerous pre-clinical and clinical research positions in neuroscience, affording him an opportunity to develop innovative techniques in the management and methodology of clinical research. Sean has exceptional experience in the development of several phase I studies, such as oncology, psychiatric, neuro, and pain. Prior to Compass Research Sean co-founded and served as the Chief Operating Officer of Clinical Neuroscience Solutions, a successful clinical research network. He began his career as a clinical research coordinator at the University of Cincinnati Medical Center, Department of Psychiatry. Sean has a Bachelor’s degree in Biology from the University of Cincinnati.

Robyn Sweet
Senior Vice President
Clinical Trial Solutions for Axiom Law
Robyn Sweet is Senior Vice President, Clinical Trial Solutions for Axiom Law, the leading global alternative legal services provider and an SCRS Global Impact Partner. In this role, Robyn is responsible for designing and bringing to market innovation solutions that leverage legal talent and analytics-driven technology to change the clinical contracting dynamic, ultimately reducing cycle times and improving the Site / Sponsor relationship. She is currently the Executive Sponsor for the UNC Chapel Hill client relationship which will be presented as a case study in this workshop. Robyn joined Axiom 6 years ago to focus on technology innovation in commercial contracts and is now leveraging that experience within Clinical Trials. Prior to joining Axiom, Robyn spent 20+ years in tech-enabled business process outsourcing focused on solution architecture and implementation in large, complex clients. She started her career in process and technology consulting at Accenture and Deloitte Consulting.
John Trbovich
Co-Founder & General Partner
Arsenal Growth
John Trbovich is Co-Founder of Arsenal, and has nearly twenty-five years’ experience advising growth companies. He was previously a co-founding Principal of E*OFFERING, a senior technology banker at Robertson Stephens & Co., an associate at Metzler Corp. Merchant Banking and an investment banking analyst at Salomon Smith Barney. Mr. Trbovich is a graduate of the Harvard Business School and the School of Engineering at Columbia University.
Mary-Anne Tomas, BSc
Director, Site Intelligence & Feasibility
Currently working at Pfizer as a director in Site Intelligence and Feasibility, Mary-Anne has acquired a vast amount of clinical trial experience, having been in the industry for almost 20 years. Gaining her start at Bayer as a Clinical Research Associate and subsequently moving to Sanofi, Mary-Anne was able to build a solid framework in varying therapeutic areas, becoming well-versed in GCP/ICH principles as well as compound development objectives of a pharmaceutical company. Subsequently accepting a position with Covance allowed for increased understanding of clinical operations. At Covance, Mary-Anne held positions as a Senior Clinical Research Associate, Clinical Trial Lead, Clinical Operations Manager, and Associate Director of Site Partnerships. In her current position at Pfizer, Mary-Anne strives to improve the experience of working with Pfizer by building knowledge of sites and capabilities, thus ensuring that patients have access to clinical trials, through proper site selection.
Devora Torrence
Founder & President
Centex Studies, Inc.
Devora Torrence is the founder and President of Centex Studies, Inc., a Texas-based SMO. She started her career as a coordinator for a research site located in Austin, but soon moved back to Houston to start her own site with her husband. Centex has now been in business about 12 years and has three multi-specialty site locations with experience in a wide range of indications. Devora now how has a total of about 15 years in the clinical research industry and her passion and dedication is still going strong.
Shirley Trainor-Thomas, MHSA
Phase Up Research, LLC
Shirley is an accomplished, creative professional with unique, multifaceted experience within both the healthcare and research industries with proven ability to capitalize on untapped opportunities through strategic planning and execution. In her role as President of Next Phase Clinical Research, she works closely with healthcare providers to identify needs, set goals and develop strategies.  From gauging organizational culture to providing business development guidance, her expertise compliments operationally-focused strategies for comprehensive planning for success.  Shirley earned her Bachelor’s degree from the University of South Carolina and her Master’s in Health Services Administration from the Medical University of South Carolina.  She is an active member of the Association of Clinical Research Professionals, serving on its Editorial Advisory Board for Clinical Researcher, the association’s peer-reviewed publication. Additionally, she is a speaker and author within the research and healthcare industries. 
Chris Trizna
Chris Trizna is the president of CSSi , whose focus is on increasing site performance and optimizing patient enrollment. Chris founded Clinical Site Services in 2005 with a mission to address the pharmaceutical industry’s need for site-specific patient recruitment and enrollment solutions. In 2010, CSS went global and the company name was changed to CSSi. Since then, CSSi has supported studies in over 50 countries with a focus on providing country-specific enrollment expertise. Chris is considered an industry thought leader; he has presented at numerous conferences and meetings and been published surrounding the topic of patient enrollment. A devoted Washington Redskins fan, Chris enjoys playing soccer and also coaching his kids’ sports teams. His “weekend satellite office” is often on a boat in the Chesapeake Bay, trying to catch the next big fish. 
Michael Tucker
Senior mHealth Solutions Specialist
Medidata Solutions
Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last six years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials. His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research. Michael has been a participant in two clinical trials...but had to consent on paper because eConsent had not been invented yet! Michael is a decorated veteran of the United States Navy and resides in Austin, Texas where he is an elected public official, serving his local community.
Michaela Vancova Ing., MPH
Clinical Operations Director, Co-founder
Slovak Research Center
Michaela is a chemical engineer with a Masters in Public Health and 12 years of experience in clinical research. She has had a variety of experiences in different positions -  from CRA, LCRA, PM in both CROs and big Pharma companies to founding Slovak Research Center, where she is the Clinical Operations Director. Previous companies: Icon, KCR, Octapharma, Boehringer Ingelheim. 

Laura Van Hagen, BS
Study Start-Up Manager
Laura is a Study Start-up Manager within the global Product Development Country Clinical Operations group and has been with Genentech for over 12 years. In her various capacities over the years, she has worked directly with investigators and site staff on clinical trials in all phases and across more than a dozen indications. Her passion for study start-up led to her current role overseeing feasibility and site activation in North America where her focus is delivery of activated sites while establishing and strengthening site relationships from the first contact. Laura is currently on rotation with the Investigator Relations program and is also a key member of the initiative leadership team.

Lindsay Vaugh
Business Director
Medical ResearchSouth
Lindsay started her clinical research career by chance while working in healthcare marketing. She worked for a smaller clinical research facility for a few years and currently handles the day to day business operations & development at Medical Research South as well as managing business development for Medical Research Alliance, a network of 19 sites within the US.
Karri Venn, RD, CDE, CCRC
President, Research
LMC Manna Research
Karri Venn brings over 19 years of clinical research experience working at LMC|Manna Research. Ms. Venn has brought experience, knowledge and drive to many of the positions held at LMC Healthcare. In 2006, Ms. Venn was promoted to Director, Research of LMC Clinical Research and subsequently in 2015 to President, Research of LMC|Manna Research with a key responsibility of integration of Manna Research with LMC to create the largest clinical community research site network in Canada. Additional responsibilities include the successful openings of 11 LMC Diabetes clinics across Canada which is now the largest Endocrinology group practice in the world and the opening of Canada’s only Diabetes Clinical Pharmacology Research Unit. In total, there are 19 sites that include expertise in all phases of research from Primary Care to Metabolic Focus. Ms. Venn has led the project management teams for > 1500 clinical trials and led the response to > 40 Sponsor & Regulatory audits. LMC|Manna has become a reputable program and has received the distinct award as a Centre of Excellence in Diabetes clinical research, awarded in the Top 50 Great Places to Work for Canada in 2014 & 2015, SPRIA winners at the 2017 SCRS conference and the CROY win for CRC at the ACRP 2017 conference. Ms. Venn has been certified in project management through the Project Management Institute, as well as longstanding certification as a Clinical Research Coordinator and Diabetes Educator.

David Vulcano, LCSW, MBA, CIP, RAC
VP Clinical Research
David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards, initiatives, publications, presentations and contributions. A native of New Orleans, he has a Masters degree in both Social Work and Business Administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC).  He even is a Certified Blockchain Professional.  Among other things he is the a Vice President and Responsible Executive for Clinical Research for HCA Healthcare, providing research-related compliance and strategy consultation to their portfolio of hospitals, physician practices and healthcare technology companies.   He is also the President of the Nashville Angel Capital Group.  David and his wife are empty-nesters living south of Nashville, Tennessee with where they involve themselves in work, family life as well as other charitable and entrepreneurial opportunities. 
Sean Walsh, MBA, ACHE
Director of Site Development
Mr. Walsh recently joined the Clin-Edge team after leading the award winning Raleigh Neurology Clinical Research Site. With over 20 years of medical management experience from hospital systems to practices, Mr. Walsh will utilize his knowledge and expertise to help the Clin-Edge network integrate research as a care option within large health systems and hosptials. Mr. Walsh also enjoys camping and playing music.
Susan Walsh
VP & Site Strategy
Total Clinical Trial Management
Susan Walsh is a business developer for CROs, Diagnostic Labs, Functional Service Providers and Technical Groups. Walsh’s colorful 35-year career includes working for government-public entities, private organizations and key positions in major corporations. Today, she is a developer of CRM Systems, Dashboards, processes and methodologies for improved professional communications, and more effective networking between buyers and sellers. She has a penchant for training professionals in process improvement and Total Quality Leadership, and has conducted hundreds of process improvement exercises, leading others to apply best business practices. She is teacher, speaker, YouTube enthusiast, mother and enthusiastic supporter of helping young minds find their passion.
Rick Ward
Vice President, Commercial Operations
Trifecta Clinical, USA
Rick Ward is Vice President of Commercial Operations at Trifecta - a leading global clinical technology solutions provider, producing more than 350 live, on-demand and web-based Investigator meetings each year in 87 countries. Prior to joining Trifecta, Rick has driven commercial growth strategies and led business development efforts for various CRO and niche service organizations supporting the Clinical Trial industry. Rick has over 20 years of business development experience, in both direct sales and sales management roles. Rick graduated with a degree in Marketing from the Pennsylvania State University and is a member of the Hammond Society, having served on Penn State’s Smeal College of Business Alumni Society Board of Directors from 1999 through 2013. Rick is also one of the founding members and former President of the Smeal Business Club of Philadelphia.
Terrra Wessel
Site Partnership Manager
Terra Wessel has over 18 years of clinical research experience working in multiple sponsor and CRO companies in various positions. Throughout her career, Terra has been an integral part of many committees and focus groups including training, mentoring, leadership and process improvement initiatives. In her current role as site partnership manager, Terra strives to build strong collaborative relationships with sites to drive operational excellence and performance.
Barbara Wenrich
Clinical Research Manager, ONC TA Lead
Barbara is a Clinical Research Manager in the US Site Management and Monitoring organization at AstraZeneca with 21 years of pharmaceutical industry experience. She is experienced in various therapeutic areas with a passion for oncology research. Currently, Barbara is the oncology therapeutic area lead in US Site Management & Monitoring. She is an active member of the RbQM Implementation team at AstraZeneca working to incorporate a risk-based monitoring approach internally and at research sites.

Amanda Wright
Executive Director
Greater Gift
Amanda Wright has been involved with Greater Gift since its inception in 2010. As of 2013, Amanda assumed the role of Executive Director for Greater Gift, and since that time, she has led program development and expansion to include more than 30 industry partners. Ms. Wright has a passion for patient engagement and believes that the patient needs to be the top priority for those innovating and collaborating. She serves on numerous boards and committees throughout the industry, many of which are centered around the engagement of patients and enhancement of the clinical trial process to address current industry trends. When she is not working, she enjoys cheering on her sons at sporting events and spending time on her farm.

Michael Yon
Mr. Michael Yon has been President of Hylant Nashville Office at Hylant Group, Inc. since May 2016. Mr. Yon is responsible for developing the strategic vision and driving the continued growth and profitability of the Nashville office. Joining Hylant in 2002, Mr. Yon has designed and managed many diverse property and casualty insurance programs, including specialized solutions for pharmaceutical, medical device and clinical research affiliated companies.