Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I

Linda Coleman is the director of the Human Research Protection Program. In her role, she is responsible for providing administrative and regulatory oversight over the Yale IRBs, RDRC, RIDC, and performing a number of functional duties including, serving as the lead for inquiries regarding audits and inquiries from regulatory agencies and accreditation bodies; assessing HRPP policies and practices for operational efficiency and compliance with applicable laws, guidelines, accreditation standards, and local context requirements; and collaborating with University stakeholders on operational initiatives related to research. Ms. Coleman also serves on several Yale University committees including the Institutional Conflict of Interest Committee, Investigator Conflict of Interest Committee, Institutional Biosafety Committee, Institutional Research Compliance Committee, Data Safety Monitoring Committee, and other committees focused on research policy matters.

Before joining Yale, Ms. Coleman held several positions at Quorum Review, an independent IRB that serves institutional, independent, and international sites. (In 2016, Ms. Coleman served as Quorum’s Vice President of Regulatory & Legal Affairs of Kinetiq, Quorum’s consulting. 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.) From 2003 – 2007, Ms. Coleman was an attorney at Bennett, Bigelow & Leedom where her practice focused on general health law matters, Medicare and Medicaid reimbursement, litigation, business/transactional, behavioral health, and employment law.

Ms. Coleman is actively involved with several professional organizations. 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 topics such as operations management, good clinical practice, research oversight, the operationalization of regulatory and institutional requirements pertaining to research, and global bioethics.