Regulatory Manager

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Description
TITLE: REGULATORY MANAGER, 6 MONTH CONTRACT
Job Summary
The Regulatory Manager is responsible for the oversight of the Regulatory Coordinators, ensuring the following tasks are completed efficiently and effectively: accurate compilation and submission of protocols and related study documents to the FCCC Scientific Research Review Committee (RRC) and designated Institutional Review Board (IRB); maintenance of CTO Regulatory Study Files to ensure all essential regulatory documents are complete and current in accordance with CTO Standard Operating Procedures (SOP), IRB Policy and Procedures, External Study Sponsor requirements, Good Clinical Practice Guidelines (GCP), and federal regulations and requirements as set forth by the Food and Drug Administration (FDA), National Cancer Institute (NCI), and Office of Human Research Protection (OHRP); and the proper conduct of clinical trials at Fox Chase Cancer Center, including Jeanes Bone Marrow Transplant (BMT) Unit and the Cancer Center at Broad Street. The Manager will also facilitate designing, improving and implementing systems to ensure efficient processing and maintenance of regulatory documents.
Education
MastersDegree: Healthcare or related field (Required)
Combination of relevant education and experience may be considered in lieu of degree.
Licenses & Certifications
CCRP - CertClinResearch Prof (Preferred) or RAC - Regulatory Affairs Cert (Preferred)
Experience
2Years experiencein Healthcare or related office environment, preferably in clinical research (Required)
5yearsexperiencein Healthcare or related office environment, preferably in clinical research. (Preferred)

Company info

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