Yale University
New Haven, CT
Linda Coleman is the Director, Human Research Protection Program (HRPP) at Yale University and has served in this capacity since 2016. Before joining Yale, Ms. Coleman held several positions at Quorum Review (now part of Advarra) including Vice President of Regulatory & Legal Affairs and Director of Regulatory Affairs & General Counsel. Prior to Quorum, Ms. Coleman was an 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 professional organizations. She is on the Board of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), serves as Co-chair of the DHHS Secretary’s Advisory Committee on Human Research Protection (SACHRP) Subpart A Subcommittee, and is a member of the Industry Pharmacogenomics Working Group (I-PWG ) Education Task Force. She also recently completed a three-year term on SACHRP.
Some of her areas of involvement include IRB harmonization, decentralized clinical trials, common rule and sIRB implementation strategies, research data protection, clinical trial process improvement, research quality and compliance, and the use of technology in research. She is also a frequent presenter on a variety of topics such as operations management, research integrity, good clinical practice, research oversight, the operationalization of regulatory and institutional requirements pertaining to research, and global bioethics.
A02 - [IN-PERSON/RECORDED] A Dialogue With SACHRP
Monday, December 4, 2023
1:00 PM – 2:00 PM ET
C04 - [IN-PERSON/RECORDED] Exception From Informed Consent (EFIC): Overview and Common Pitfalls
Monday, December 4, 2023
3:45 PM – 4:45 PM ET
Wednesday, December 6, 2023
10:15 AM – 11:15 AM ET
H15 - [IN-PERSON ONLY] Oversight Committee Interaction in Clinical Research Beyond the IRB
Wednesday, December 6, 2023
1:45 PM – 2:45 PM ET