Clinical Trials Regulatory Coordinator - Urology

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 policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). The Clinical Research Coordinator collaborates with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support.

The full hourly salary range for this position is $ 31.51 - $62.64. Please note that the department's target hourly pay is $31.51.