Clinical Trial Research Monitor II

Temple University Health SystemPhiladelphia, PA
Onsite

About The Position

The OCR Clinical Research Monitor II completes, revises, and reviews the requirements necessary for 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 certifications, related training, or education programs may be considered in lieu of those listed (i.e., Regulatory Affairs).

Requirements

  • Bachelor's Degree in Science or other health care discipline
  • 2 years of experience in oncology
  • 2 years of experience working as a Clinical Research Monitor
  • Certified Clinical Research Associate (CRAC) or Certified Clinical Research Coordinator (CRCC) or Certified Clinical Research Professional (CCRP)

Nice To Haves

  • Master's Degree in Clinical Research or other applicable science or healthcare discipline
  • Combination of relevant education and experience may be considered in lieu of degree
  • 3 years of experience in oncology clinical research

Responsibilities

  • Completes, revises, and reviews requirements for FDA and regulatory body compliance in clinical trial research.
  • Monitors extramural research program investigator-initiated studies at FCCC and other academic institutions.
  • Ensures protocol compliance at clinical research sites.
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