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Clinical Trials Regulatory Coordinator - Urology
DescriptionUnder 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 maintain
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