Hybrid Compliance Coordinator - WVU Cancer Institute​/Clinical Research Unit

Job Description - (Hybrid) Compliance Coordinator - WVU Cancer Institute/Clinical Research Unit (28766) (Hybrid) Compliance Coordinator - WVU Cancer Institute/Clinical Research Unit 28766 Description

The WV Cancer Institute/Clinical Research Trials at West Virginia University is currently accepting applications for a (Hybrid) Compliance Coordinator.

The Compliance Team is a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) tasked with the monitoring and/or auditing of select trials to ensure compliance with established health authority regulations as well as collaborating with clinical research teams for the implementation of remediating action plans and processes within WVUCI as well as affiliated and partner sites in our Investigator Initiated Trials.

We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

• 37.5-hour work week
• 13 paid holidays ( staff holiday calendar )
• 24 annual leave (vacation) days per year ( employee leave )
• 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information ? Check out retirement health insurance benefits, retirement income, and FAQ’s.
• Wellness programs

• Conduct and document assigned periodic monitoring according to the monitoring plan which includes verification of subject safety and adherence to Institutional, WVUCI CRU, federal and state regulations and specific protocol requirements including:

  • Verification of subject study research data including informed consent process, eligibility, treatment, follow-up, and safety reporting documentation to ensure compliance with study protocols.
  • Review of study-related regulatory documentation such as correspondence, delegation logs, institutional review board communication, deviations, and progress reports for each assigned study.
  • Verifies validity of research results by ensuring timely, accurate, and complete source data and Case Report Form documentation.

• Quality Assurance and Quality Control:

  • Lead collaborations with clinical research teams in non-compliance issue identification, finding solutions and implementing corrective and preventive action plans and processes to remediate issues.
  • Follows monitoring procedures and tools for investigator-initiated IND or IDE-enabling clinical trials (or other trials as needed where there is no external sponsor/monitor).
  • Support the clinical research team by ensuring they have adequate training and processes for the responsible conduct of research.
  • Generate monitoring reports and ensures any non-compliances are adequately resolved in a timely manner.
  • Participate in the preparation and follow-up activities for regulatory agency and Sponsor audits as needed to ensure successful outcomes
  • Present findings and recommendations for areas of improvement to management in areas that affect clinical research programs at the institution.
  • Assist in identifying training needs and in developing and/or executing training programs for study staff and supporting departments.

• Data Safety and Toxicity:

  • Coordinating internal Data Safety and Toxicity Committee meetings and subsequent review sessions as needed. Meetings to include review of internal unanticipated events and response assessments, external safety reports, investigator initiated trials monitoring reports per DSMP and external audit findings.
  • Perform secondary review of eligibility for interventional clinical trials.
• Other duties as assigned. May include monitoring of external institutions participating in Investigator Initiated Trials sponsored by WVUCI

• Bachelor’s degree in…