Description

Under the direct
supervision of the Clinical Trials Administrator, The Regulatory Coordinator is
responsible for submitting and managing all regulatory documentation for the
Institute of Urologic Oncology's clinical research portfolio according to
institutional and federal guidelines. Key duties include submitting
applications to the FDA, IRB, ISPRC, DSMB, ancillary departments, and other
applicable review committees (including at start-up, for all amendments, and at
continuing review); maintaining communication with aforementioned regulatory
bodies; developing informed consent forms; and maintaining regulatory files in
paper and electronic form. The incumbent recognizes and performs necessary
tasks to manage projects and prioritizes work to meet necessary deadlines. The
incumbent is responsible for planning and organizing necessary tasks to ensure
adherence to the study protocol and applicable regulations, such as institutional<...