Associate Director of Quality Assurance
Alyssa Gateman, MPH, CCRP, is a recognized and respected QA expert who brings a wealth of experience to Yale’s QA team. She joined Yale from the Dana-Farber/Harvard Cancer Center, where she most recently served as director of the Quality Assurance Office for Clinical Trials (QACT). Throughout her 14-year tenure at Dana-Farber, she provided oversight of all protocol registration, data collection design of investigator-initiated clinical trials, and management of the internal auditing program. As director of the QACT, she provided leadership and management for the Data and Safety Monitoring Committee, Multi-Center Review Committee, Audit Committee, Clinical Investigations Leadership Committee, and Clinical Operations Committee (responsible for development of DF/HCC Policies and Procedures). She was directly involved with Dana-Farber/Harvard Cancer Center’s participation in the NCI’s Cancer Center Support Grant, as well as in a pilot initiative for the Clinical Trial Reporting Program. At YCCI, she oversees the QA staff, which supports quality initiatives for clinical research across the medical campus to ensure the conduct of high-quality, compliant clinical research. She is responsible for the enterprise-wide Quality Assurance Program of YCCI. This includes management of the 5 pre- and post- review committees; oversight of the QA and multi-site monitoring staff and unit functions; all pre-and post- FDA audit planning and management; and oversight of the development and implementation of corrective and preventative action plans as a result of issues raised during audits. Additionally, Ms Gateman works closely with the IRB and other internal and external regulatory bodies to ensure the highest standard of research at Yale.