Clinical Research Coordinator I - Frenova

Job description

PURPOSE AND SCOPE: Supports Frenova Renal Research by providing administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity. PRINCIPAL DUTIES AND RESPONSIBILITIES: - Utilizes experience and knowledge to act as a resource and provide on-going leadership and support to Clinical Research Assistant I, answering questions and providing assistance as needed - Conducts on the job training for Clinical Research Assistant I as requested - Researches and identifies research related issues and discrepancies when evident and appropriately escalates to site manager, Director, and/or principal investigator for resolution as needed - Obtains and prepares regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional lice...