POSITION SUMMARY: Functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. KEY RESPONSSIBILITIES: Responsible for the preparation and finalization of project and study related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required Responsible for the selection of investigators and study sites responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to
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