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Temple Health – Temple University Health System · 1 day ago

SR REGULATORY COORDINATOR

Philadelphia, PA

Full-time

Onsite

Mid, Senior Level

4+ years exp

Temple Health – Temple University Health System is seeking a Regulatory Coordinator III responsible for compiling and submitting protocols and related study documents to various committees and boards. The role involves maintaining regulatory study files and ensuring compliance with relevant guidelines and regulations for clinical trials.

Health CareHealth DiagnosticsHospitalUniversities

Responsibilities

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)

Maintain 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)

Qualification

Regulatory Affairs CertificationClinical Research CertificationOncology Clinical TrialsClinical Practice GuidelinesFDA RegulationsIRB SubmissionBachelor's DegreeMaster's Degree4 Years Regulatory Experience5 Years Clinical Research Experience

Required

The OCR Regulatory Coordinator III 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)

CCRP or RAC Certification is required within 1 year from date of hire

Bachelor's Degree Required

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

4 years experience in a regulatory role or 5 Years experience in related clinical research role Required

General Experience In Oncology Clinical Trials Required

Cert Clin Research Prof Required

Regulatory Affairs Cert Required

Preferred

Master's Degree Preferred

Company

Temple Health – Temple University Health System

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At Temple Health, patients have access to some of the most advanced research and clinical care — tools we are using to help achieve outcomes once thought to be impossible.

Founded in 1995

Philadelphia, Pennsylvania, USA

5001-10000 employees