(Hybrid) Quality Assurance Auditor - Clinical and Translational Science Institute

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 improving health outcomes for West Virginia.
  
  

• Bachelor's degree in a related field
• A minimum of two (2) years of experience in the following:
  
  
  
  • Regulatory and/or quality aspects of pharmaceutical and/or medical device industries or government-sponsored clinical research studies
  
  
  
  
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.

Knowledge, Skills and Abilities

• Working knowledge of regulatory aspects of pharmaceutical and medical devices industries and government sponsored clinical research studies including institutional review board (IRB) regulations, US FDA Code of Federal Regulations (US FDA CFR) & Guidance, National Institute of Health (NIH), International Conference on Harmonization (ICH) GCP, Medicines and Healthcare Products Regulatory Agency (MHRA), Therapeutic Products Directorate (TPD) or Health Canada, etc.
  
• Working knowledge of developing investigational new drug (IND) or abbreviated new drug applications (ANDA), or premarket approval (PMA), and in vitro diagnostics (IVD) safety reports.
  
• Skilled at problem solving.
  
• Excellent oral and written communication skills.
• In depth knowledge of GCP regulations, quality systems, quality assurance and quality control.
• Strong problem-solving, risk assessment and impact analysis abilities.
• Strong work processing skills and understanding and the ability to handle stress and work under pressure.
• Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Strong time management skills and ability to prioritize and manage multiple projects simultaneously.
  
• Computer proficiency and familiarity with use, including Microsoft Office.
  
• Demonstrated ability to work effectively in both cross-functional teams and independently is required.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
  
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Must be able to read and understand large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.

• Within two (2) years of employment, incumbent must obtain certification through the Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA) or Society of Quality Assurance (RQAP-GCP).
• Due to the nature of this job, it may require Medical Monitoring.

The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.

The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value 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.