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, an independent IRB that serves institutional, independent, and international sites. (Ms. Coleman served as Quorum’s Vice President of Regulatory & Legal Affairs of Kinetiq in 2016, a consulting division of Quorum. Prior to 2016, she served as Quorum’s Director of Regulatory Affairs & General Counsel from 2011–2015, and its Director of Regulatory Affairs from 2007–2010.) Prior to Quorum and Kinetiq, 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 and is a member of the DHHS Secretary’s Advisory Committee on Human Research Protection (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.
Disclosure information not submitted.
Wednesday, November 17, 2021
10:00 AM – 11:30 AM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Thursday, November 18, 2021
11:30 AM – 12:45 PM ET
HRPP/IRB Management 101: Real-World Discussions Regarding How to Effectively Run a HRPP/IRB Office
Thursday, November 18, 2021
3:00 PM – 4:00 PM ET