Associate Director of Regulatory
Patricia A. Seymour, CCRC, MA, CIP assumed the role of interim Director, Human Subject Protection Program in January of 2015. In that role, she managed five IRBs, contributed to the selection and implementation of an online system for IRB management and successfully identified and oriented a replacement Director for the program. Ms. Seymour joined the YCCI team in April of 2016 as the regulatory director. In addition to serving as a resource for regulatory questions and policy development in YCCI, she assists faculty with writing and developing clinical and other research studies.
Prior to her positions at Yale University and the YCCI, Ms. Seymour was a consultant and employee at organizations and Universities in the United States where she specialized in IRB/HRPP program assessment and improvement. She has been responsible for serving as interim director at several Universities which required operational assistance to maintain their IRBs or in cases where OHRP or FDA had expressed serious concerns. As a consultant for Western IRB, she was responsible for traveling the U.S. to research sites and Universities to assist in the implementation of WIRB as a local IRB. Her work with Universities contributed to WIRB becoming the external IRB of choice for many Universities today.
In the 1990s, Ms. Seymour was responsible for the management of 40 sites in a national site management organization. Through writing and implementing SOP for site operation, budgets and contracts, quality assurance and regulatory submissions, Ms. Seymour was responsible for assuring that the sites were operated according to one standard of best practice and quality.
Ms. Seymour has also contributed to the de novo development of several academic and independent IRBs. With her extensive knowledge of both academic affairs and corporate organizations, she was able to develop a free standing IRB which brought together University Hospitals of Cleveland, Cleveland Clinic and Case Western Reserve University to collaborate on a shared Oncology IRB. Similarly, she was responsible for founding the Oncology IRB for Quorum Review in Cambridge, MA. She developed and managed new IRB panels at Columbia University, University of Miami and the reorganization of IRBs at Boston University, Charles River Campus and other independent IRBs.
Ms. Seymour has been invited to speak on GCP, Investigator Responsibilities and site management topics in the U.S., Southeast Asia and Central America. She has trained IRB members and investigators both new and experienced, on ethical issues facing them as well as programs for understanding the U.S. regulatory and corporate pharma system. She is an AAHRPP site visitor and has successful contributed to three AAHRPP accreditation projects.