Research Quality Specialist-Lead

Coordinates on-site reviews of selected clinical projects to assess compliance with federal regulations, Institutional Review Board (IRB) requirements, and University policies. Monitors and evaluates site visit auditors work and oversees the drug distribution and delivery system. Writes audit reports, facilitates educational programs for the research community, updates information as pertains to federal regulations and applicable policies, and analyzes and conveys audit data to assist in addressing inaccuracies.