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Regulatory Coordinator II

3 months ago

Philadelphia, Pennsylvania, United States Temple University Health System Full time

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).

Education

Bachelors Degree (Required)

Masters Degree (Preferred)

Combination of relevant education and experience may be considered in lieu of degree.

Experience

2 Years experience in a regulatory role or 4 Years experience in related clinical research role (Required)

Experience in oncology clinical trials (Preferred)

License/Certifications

CCRP - Cert Clin Research Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred)

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