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Regulatory Coordinator II at Temple Health System

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Apr, 26

Salary

0.0

Posted On

18 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Clinical Trials, Protocol Submission, Study Documentation, Good Clinical Practice, FDA Regulations, NCI Guidelines, OHRP Requirements, Oncology Research, Data Management, Research Review, File Maintenance, Essential Documents, Research Ethics, Collaboration, Attention to Detail

Industry

Hospitals and Health Care

Description

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 Bachelor's Degree Required Master's Degree Preferred or Combination of relevant education and experience may be considered in lieu of degree Required Experience 2 years experience in a regulatory role or 4 Years experience in related clinical research role Required General Experience in oncology clinical trials Preferred Licenses Cert Clin Research Prof Preferred or Regulatory Affairs Cert Preferred

Responsibilities

The OCR Regulatory Coordinator II is responsible for compiling and submitting protocols and related study documents to the appropriate committees and boards. They also maintain regulatory study files to ensure compliance with various policies and guidelines.