Senior Research Regulatory Coordinator - RI Gene Ther

Overview: Job Description Summary: Coordinates the regulatory and compliance process of all clinical research conducted in the NCH/RI system. Oversees the preparation and submission of regulatory and compliance documents to study sponsors and assists with quality improvement initiatives. Coordinates submissions of human subjects research project to the Institutional Review Board (IRB) andof Investigational New Drug Applications (IND’s) to the U.S. Food and Drug Administration (FDA). Job Description: Essential Functions: Reviews study protocols in order to write consent/assent documents and develop the initial IRB submission; submits protocol amendments; responds to contingencies and obtains final approval of documents from sponsor and IRB, on behalf of principal investigator.…