Philadelphia, PA30+ days ago
The OCR Regulatory Coordinator II is responsible for the accurate compilation and submission of protocols and related study documents to the FCCC Scientific Research Review Committee (RRC) and applicable Institutional Review Board (IRB), for maintaining OCR Regulatory Study Files to ensure all protocols and essential regulatory documents are complete and current in accordance with OCR and FCCC IRB Policy and Procedures, External Study Sponsor requirements, Good Clinical Practice Guidelines (GCP) and federal regulations and requirements set forth by the Food and Drug Administration (FDA), National Cancer Institute (NCI), and Office of Human Research Protection (OHRP) for the proper conduct of clinical trials at Fox Chase Cancer Center, Temple-Jeanes Bone Marrow Transplant (BMT) Unit and Temple University Cancer Center (TUCC). Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team.