Hybrid Quality Assurance Auditor​/Regulatory Associate - Clinical and Translational Science

The Clinical and Translational Science Institute at West Virginia University is currently accepting applications for a (Hybrid) Quality Assurance Auditor/Regulatory Associate.

The Quality Assurance Auditor is responsible for the monitoring and 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 across the West Virginia Clinical and Translational Science Institute (WVCTSI) Clinical Trials Center of Excellence (COE). This position will also serve as a Regulatory Associate.

The Regulatory Associate examines, evaluates, and investigates conformity with the regulatory aspects of industry and government sponsored clinical trials and investigator initiated clinical research. This includes securing Institutional Review Board (IRB) approval and maintaining all records pertaining to IRB approval and oversight.

• 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

• Leads collaborations with clinical research teams in non‑compliance issue identification, finding solutions and implementing corrective and preventive action plans and processes to remediate issues.
• Implements 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).
• Conducts and documents assigned periodic monitoring according to the monitoring plan, which includes verification of subject safety and adherence to federal and state regulations and specific protocol requirements including:
  • Verification of subject study research data including informed consent process, eligibility and safety reporting documentation to ensure compliance with study protocols, regulations and ICH/GCP guidelines periodically throughout study conduct;
  • 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.
  • Support of the clinical research team by ensuring adequate training is provided and processes for the responsible conduct of research are followed.
  • Generation of monitoring reports and adequate and timely resolution of any non‑compliances.
• Participates in the preparation and follow‑up activities for regulatory agency and Sponsor audits as needed to ensure successful outcomes.
• Participates in meetings to present findings and recommendations for areas of improvement to management affecting intuitional clinical research programs.
• Assists in the development and maintenance of tools for quality metric tracking.
• Assists in identifying training needs and in developing and/or executing training programs for study staff and supporting departments.
• Participates in internal audits of clinical trials, as needed, to verify subject safety and data integrity were maintained and identify areas of non‑compliance.
• Participates in building research infrastructure through collaboration with other WVCTSI cores to contribute to the overall mission of the WVCTSI of improving health outcomes for West Virginia.

• Plans and writes materials for…