MCSE, CIP, CPIA, CRQM, VP, Research Services & Strategic Consulting
20+ years of progressive leadership experience in life science with leading private and academic programs in the healthcare, human subject protections, biosafety, and lab animal care and use fields.
Expertise includes large program management and growth, operational processes, development and implementation of technology solutions, and management of large Human Research Protection Programs (HRPP), Biosafety programs (IBC) and Institutional Animal Care and Use programs (IACUC). James has directed numerous clients in achieving Part 11 compliance and meeting computer system validation requirements. He is also adept at helping sponsors, health systems, and research institutes revitalize research programs.
James has served on the board of the Northwest Association for Biomedical Research (NWABR) and the steering committee of the Clinical Trials Transformation Initiative (CTTI). He has also served as a site visitor for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). In addition to being on the editorial board of the journal IRB Advisor and the leadership team for the Alliance for Clinical Research Excellence and Safety (ACRES) Committee on Accreditation, he is a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R) and other industry conferences.