Temple University Health System·Philadelphia, Pennsylvania
The role involves monitoring extramural research program investigator-initiated studies to ensure protocol compliance at clinical research sites. It also requires reviewing and revising documentation to maintain compliance with FDA and other regulatory bodies.
The OCR Clinical Research Monitor II, completes, revises and reviews the requirements necessary to attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level.
Monitors all extramural research program investigator initiated studies being conducted at FCCC and other academic institutions. Ensures protocol compliance at the clinical research sites. Other applicable certification, related training, or education programs may be considered in lieu of those listed below (i.e. Regulatory Affairs).
This role is located in Philadelphia, PA and no traveling is required.
Education Bachelor's Degree Science or other health care discipline Required Master's Degree Clinical Research or other applicable science or healthcare discipline Preferred or Combination of relevant education and experience may be considered in lieu of degree Required
Experience 2 years experience in oncology Required 2 years experience working as a Clinical Research Monitor Required 3 years experience in oncology clinical research Preferred
Licenses Cert Clin Research Associate Required or Cert Clin Research Coordinator Required Cert Clin Research Prof Required
Candidates must have a Bachelor's degree in science or healthcare and at least 2 years of experience in both oncology and clinical research monitoring. Required certifications include CCRA, CCRC, or CCP.
Market context
In Pennsylvania, Clinical Trial Research Monitor II roles are typically driven by ongoing oncology research activity and the need for experienced monitors who can support protocol compliance and site oversight. These roles are competitive because employers often want a bachelor’s degree in science or healthcare, at least 2 years of oncology and clinical research monitoring experience, and a CCRA, CCRC, or CCP certification. Review the AI-summarized requirements and benefits on this platform to quickly compare fit, then tailor your application to highlight oncology monitoring, regulatory documentation, and site communication experience.
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