Full employer posting
Serves as an expert for FCCC research community on all matters related to the NCI Clinical Trials Support Unit (CTSU); providing CTSU training for all staff. Oversees compliance with all aspects of managing these research studies by assuring protocol compliance through monitoring, audit preparation, distribution of data quality and performance monitoring for both parent and child sites. Oversees and directs Research Quality Assurance Analysts activities related to NCI and NCTN monitoring/risk-based auditing and audit preparation and assures adequate responses are submitted when required to the appropriate NCI body.
Completes, revises and reviews the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for all clinical trial research both from a documentation and process level with special attention on National Clinical Trials Network (NCTN) and NCI studies. Promotes adherence to ICH-GCP guidelines, ensures that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected.
Education Bachelor's Degree Science or other health care discipline Required Master's Degree Quality Assurance/Regulatory Affairs or health care discipline Preferred or Combination of relevant education and experience may be considered in lieu of degree Required Experience 5 years Experience auditig NCI and NCTN studies Required 5 years experience in clinical trials auditing Required 5 years experience in oncology Required Licenses Cert Clin Research Associate Preferred or Cert Clin Research Coordinator Preferred or Cert Clin Research Prof Preferred Assn Clin Res Prof - Cert Prof Required Your Tomorrow is Here!
Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team.
Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here!
Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Full-Time · Day Shift · 40 hours per week
About the role
Oversees compliance with all aspects of managing these research studies by assuring protocol compliance through monitoring, audit preparation, distribution of data quality and performance monitoring for both parent and child sites.