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

West Virginia University

6d • Hybrid

About The Position

The Clinical and Translational Science Institute at West Virginia University is currently accepting applications for a (Hybrid) Quality Assurance Auditor/Regulatory Associate.
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). 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.
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%25 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

Requirements

• Bachelor's degree in 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.
• 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) & Guidances, 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. Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Excellent oral and written communication skills.
• Strong customer service skills, with the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• 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.
• 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 with a keen attention to detail.
• Ability to write reports, business correspondence, and procedure manuals clearly and accurately.

Responsibilities

• 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 IRB submissions.
• Reviews submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
• Develops and prepares informed consent documents according to institutional guidelines.
• Submits study protocol amendments to the IRB.
• Assists with the submission of IND safety reports and adverse event reports to the IRB.
• Tracks IRB submissions and communicate with IRB administration regarding new submissions and approved protocols.
• Monitors, evaluates and improves regulatory submission tracking/control systems.
• Submits appropriate documents to close or suspend study protocols.
• Submits and tracks regulatory documents in the clinical trials management system (CTMS) utilizing the workflow and processes
• Assists in networking opportunities and continuing education.
• Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility and adheres to industry and government standards.
• Assists and/or follows direction of management to determine the best course for customer service.
• Communicates with investigators, coordinators, and sponsors by email, telephone or in-person.
• Responds to questions regarding regulatory issues.
• Gathers anecdotal and raw data, assesses situations or program information, considers options, proposes resolutions, creates reports and translates data to graphical media or code.
• Assists with or complete forms for IRB submissions, etc.
• Trains users regarding electronic IRB applications.
• Contacts investigators, coordinators, and sponsors to establish rapport, understanding and/or inform, as well as to facilitate use of programs, services, and/or products.
• Adjusts, refers for and/or investigates complaints.
• Testifies before auditors and administrators.

Benefits

• 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%25 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level