Shire Jobs

Description The WV Clinical and Translational Science Institute at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Quality Assurance Auditor About the Opportunity 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). At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs: 13 paid holidays (staff holiday calendar) Paid Time off (PTO) 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC) A range of health insurance and other benefits Dependent Education Scholarship WVU Perks What You'll Do 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. Implement 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. 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. Supports the clinical research team by ensuring they have adequate training and processes for the responsible conduct of research. Generates monitoring reports and ensures any non-compliances are adequately resolved in a timely manner. Participates in the preparation and follow-up activities for regulatory agency and Sponsor audits as needed to ensure successful outcomes. Participate in meetings to present findings and recommendations for areas of improvement to management in areas that affect clinical research programs at the institution. 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. Participate 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... For full info follow application link.

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. West Virginia University Research Corporation values diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.