Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals including SARC, Oncore, InfoEd and others; acting as primary regulatory contact person for department faculty and research staff, sponsors/Contract Research Organizations (CROs)/coordinating centers; maintaining research credentials, training documentation and licenses; The Regulatory Affairs Coordinator will work closely with the Director of Clinical Research, program managers, and clinical research coordinators. Qualifications:
Minimum Qualifications:
Bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 4-6 years of professional experience related to regulatory affairs in research administration.