PRIM&R PRESENTER
Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I
Director of the Human Research Protection Program
Yale University
Bio
Linda Coleman is the Director of the Human Research Protection Program at Yale University and has held this position since April 2016. Prior to joining Yale, Ms. Coleman held several positions at Quorum Review (now Advarra), an independent IRB and consulting organization that served institutional, independent, and international research sites. She was Vice President of Legal & Regulatory Affairs in 2016, Director of Regulatory Affairs & General Counsel from 2011 to 2016, and Director of Regulatory Affairs from 2007 to 2011. Before her time at Quorum, Ms. Coleman worked as an Associate Attorney at Bennett, Bigelow & Leedom, where her practice focused on general health law matters, Medicare and Medicaid reimbursement, litigation, behavioral health, and employment law.
Ms. Coleman is actively involved with several organizations. For example, she was a member of the Secretary’s Advisory Committee on Human Research Protection (SACHRP) from 2019 to 2022 and presently serves as Co-chair on SACHRP’s Subpart A Subcommittee (SAS). Additionally, she is currently serving on the Boards of both the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and the Northwest Association for Biomedical Research (NWABR), and she serves as an External Advisory Board Member for the Collaborative Institutional Training Initiative (CITI Program). Lastly, she has been engaged in various projects led by organizations such as the Industry Pharmacogenomics Education Task Force (I-PWG), Clinical Trials Transformation Initiative (CTTI), and the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT).
In addition to her work in human research, Ms. Coleman has been actively involved with issues related to education access and success for over 20 years through her nonprofit work. Her nonprofit work has included a strong focus on providing students with limited financial resources access to free or affordable courses and programs aimed at preparing them for success in higher education and various career-related opportunities.
Committees
PRIM&R Governance Committee, Vice Chair
PRIM&R Finance Committee