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Senior Research Quality Assurance Analysts

Temple Health•Rockledge, PA
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About The Position

The Senior Research Quality Assurance Analyst serves as an expert resource for the Fox Chase Cancer Center (FCCC) research community on matters related to the NCI Clinical Trials Support Unit (CTSU) and provides CTSU training for staff. The role oversees compliance in managing research studies, including protocol compliance, audit preparation, and distribution of data quality and performance monitoring for parent and child sites. The position oversees and directs Research Quality Assurance Analysts’ activities related to NCI and NCTN monitoring, risk-based auditing, and audit preparation, and ensures that adequate responses are submitted to the appropriate NCI body when required. It completes, revises, and reviews requirements for attaining and maintaining FDA and other regulatory compliance for clinical trial research, with particular attention to NCTN and NCI studies. The role promotes adherence to ICH-GCP guidelines, ensures reported data are accurate and complete, and protects the rights and safety of clinical research participants.

Requirements

  • Bachelor’s degree in science or another health care discipline, or a combination of relevant education and experience in lieu of a degree.
  • Five years of experience auditing NCI and NCTN studies.
  • Five years of experience in clinical trials auditing.
  • Five years of experience in oncology.
  • Association of Clinical Research Professionals (ACRP) certification as a Certified Professional required.

Nice To Haves

  • Master’s degree in quality assurance, regulatory affairs, or a health care discipline.
  • Certification as a Clinical Research Associate.
  • Certification as a Clinical Research Coordinator.
  • Certification as a Clinical Research Professional.

Responsibilities

  • Serve as an expert for the FCCC research community on matters related to the NCI Clinical Trials Support Unit (CTSU).
  • Provide CTSU training for all staff.
  • Oversee compliance with research study management requirements and assure protocol compliance.
  • Oversee audit preparation and distribution of data quality and performance monitoring for parent and child sites.
  • Oversee and direct Research Quality Assurance Analysts’ activities related to NCI and NCTN monitoring, risk-based auditing, and audit preparation.
  • Ensure adequate responses are submitted to the appropriate NCI body when required.
  • Complete, revise, and review requirements for attaining and maintaining FDA and other regulatory compliance for clinical trial research, particularly NCTN and NCI studies.
  • Promote adherence to ICH-GCP guidelines.
  • Ensure clinical trial data reported are accurate and complete.
  • Protect the rights and safety of participants in clinical research.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

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