2018 Site Solutions Summit Faculty

Greg Adams
Director Clinical Site Management
Pfizer
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
Merck
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
CliniBiz
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
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.


 
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)
PPD
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.


 
Deena Bernstein, MHS
VP Site Services
Qcare
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
PAREXEL
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.
 
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.
 
CCO
Customer Success Manager
Greenphire
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.
 
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.  
 
Christian Burns
President
ClinEdge
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
Oracle
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.
 
Cary Carrion, BS
Regional Director
Clinical Site Partners
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.
 
Ivor Clarke
CEO
SubjectWell
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
Covance
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 Feasiblity
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 of 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
Pfizer
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
Director
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. 
 
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
President
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
Medix
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.
 
Diana Foster, PhD
Vice President, Strategy & Development
Society for Clinical Research Sites
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.
 
Debbie Elliott
Executive Director
Clinical Operations at Medpace
 
Peter Fredette
Director, Oncology
IQVIA
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
Axiom
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.
 
Katie Gaiek
Account Executive
Bio-Optronics
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
Otsuka
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
COO
Florence Healhtcare
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.
 
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
CEO
Clincierge
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
CEO
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
Director
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.
 
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
StudyKik
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
ACRP
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
Qcare
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.
 
 
Ryan Haynes, MT (ASCP)
Director, Clinical Research
CSSi
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.

 
 
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.
 
Robert J. Howal, BS
Site Partnership Manager
Sanofi
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
GSK
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.

 
Ryan Jones, MBA
CEO
Florence
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.
 
Sandra Jovanovic
Director of Talent Innovation
Medix
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
CEO
GP4research
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.

 
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.
 
Irfan Khan, MD, FACC, FHRS
CEO
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
Emerson Clinical 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.
 
Barry Lake
CEO
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. 
 
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! 
 
Lorraine Large
Associate Director, Central Monitoring, EAPA, Adaptive Monitoring Leadership Team
PRA Health Sciences
Lorraine has 14 years of industry experience with PRA Health Sciences. Lorraine has worked in Clinical Operations, Study Start-Up, Project Management, Functional Management and Change and Process Management. Lorraine is currently heading up Central Monitoring in Europe, Africa and Asia-Pacific and is part of PRA’s Adaptive Trial Management and Monitoring Leadership Team. 
 
Matt Lowery, ACRP-CP, CCRC
Director
CRBD+
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.
 
Sheila Marsh, MPH
Project Lead/Sr. Clinical Research Associate
GlaxoSmithKline
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.
 
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.
 
Joy Mowery, RN, MS
Director of Clinical Site Management
Pfizer
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
Co-Founder
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. 
 
Shiela 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
President
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. 
 
Raffaella Olson, BA
Associate Director, Site Partnerships
Covance
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. 
 
Casey Orvin
EVP of Business Development
Synexus
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.

 
Mitchell Parrish, JD, RAC, CIP
Vice President, Legal & Regulatory Affairs
Kinetiq
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.

 
Christine Pierre
President
Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites (SCRS). She is internationally known for her expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition, she also addresses audiences around the world on issues pertaining to human subject protection, site operations and subject recruitment and retention. Her global reach has included presentations in Australia, Canada, Africa, Israel, and the United States.
 
Marisa Rackley, BS, MHA
PMP - Director
Vertex
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 Radjenovich
Manager, Contract Management, Global Strategic Projects
Axiom Law
 
 
Kimberly Ray
Vice President, Site & Patient Networks
IQVIA
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
President
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
 
 
Archana Sah, MS (Pharm), PMP
Therapeutic Area Leader, Oncology
Genentech
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 of 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
AstraZeneca
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
President/CEO
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.
 
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.

 
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
President
NOCCR/VRG, An AMR Company, LLC
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
GSK
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. 
 
Mary-Anne Tomas, BSc
Director, Site Intelligence & Feasibility
Pfizer
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.
 
Shirley Trainor-Thomas, MHSA
President
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
President
CSSi
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. 
 
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
Genentech
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.


 
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
HCA
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
Clin-Edge
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.
 
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.
 
Barbara Wenrich
Clinical Research Manager, ONC TA Lead
AstraZeneca
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.

 
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