ResponsibilitiesUnder the direct supervision of the Clinical Trials Administrator, coordinate, and participate in all regulatory research activities as part of the Department of Urology. The incumbent will work with the PI, Sub-Investigators, research personnel and hospital staff (collectively, the Study Team) to develop and/or conduct both investigator-initiated and sponsor-initiated clinical trials and clinical research projects funded by industry-sponsors, federal and state agencies, and other non-profit foundations and organizations. Incumbent will be responsible for preparing, managing and submitting any required study/regulatory documents, and all required applications and forms, including but not limited to: submissions to the applicable Institutional Review Board (IRB), informed consent form development, required contractual and/or grant related documents, investigational pharmacy applications, other ancillary services applications, FDA IND/IDE/510k/SAE/MedWatch applications and submissions, etc. Incumbent must have strong analytical and problem solving skills to address and resolve potential issues as they arise. Work with study monitors to process, review and collect appropriate regulatory documents in a timely manner. Work flexible hours and/or overtime to meet study deadlines and requirements.
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Internal Number: 62775356
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