Regulatory Coordinator II

Temple University Health System • Philadelphia, PA

4d

About The Position

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).

Requirements

• Bachelor's Degree Required
• Combination of relevant education and experience may be considered in lieu of degree Required
• 2 years experience in a regulatory role or 4 Years experience in related clinical research role Required

Nice To Haves

• Master's Degree Preferred
• General Experience in oncology clinical trials Preferred
• Cert Clin Research Prof Preferred
• Regulatory Affairs Cert Preferred

Responsibilities

• accurate compilation and submission of protocols and related study documents to the FCCC Scientific Research Review Committee (RRC) and applicable Institutional Review Board (IRB)
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees