Leadership - Kinetiq
Our leaders share decades of experience in clinical research, compliance, regulatory analysis, and technology:
Kinetiq Vice President, Regulatory Affairs and General Counsel
Mitchell 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 has held both in-house and outside counsel roles, having served as an associate attorney at the global law firm K&L Gates, consultant to the National Cancer Institute, and regulatory counsel to a global provider of medical research review services. He frequently speaks and writes on FDA regulatory, clinical trial, and IRB topics, including authorship of chapters on prescription drug labeling and on research in pediatric populations in the most recent edition of the Fundamentals of US
Mitchell has his Regulatory Affairs Certification (RAC) and is a Certified IRB Professional (CIP). He is Faculty for the Regulatory Affairs Professionals Society (RAPS), a Steering Committee member for Harvard’s Multi-Regional Clinical Trial Center (MRCT), a Planning Committee member for the Northwest Association for Biomedical Research (NWABR), a member of Public Responsibility in Medicine & Research (PRIM&R), and a member of both the Washington and Oregon
Kinetiq Vice President, Client Services
James brings nearly 20 years’ experience in Human Research Protections leadership. Before joining Kinetiq, James was most recently the Assistant Director at the Fred Hutchinson Cancer Research Center, where he was a leader in the world-class human subject and animal research protection programs. Prior to that James served as VP of Operations for a major accredited independent IRB. James has served on the board of the Northwest Association for Biomedical Research (NWABR) and as an AAHRPP site visitor. In addition to serving on the editorial board of the journal IRB Advisor and on the ACRES Committee on Accreditation, he is a current faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R) and other
James is one of approximately 200 persons globally to hold both the CIP and CPIA certifications. He has a degree in Accounting with emphasis in Computer Science from Western Washington University.