WVU Online

Quality Assurance Auditor/Regulatory Associate – Clinical and Translational Science Institute

WVU Online

full-time

Posted on:

Location Type: Hybrid

Location: Morgantown • Virginia • West Virginia • United States

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Tech Stack

Google Cloud Platform

About the role

  • Quality Assurance Auditor Leads collaborations with clinical research teams in non-compliance issue identification.
  • Implements monitoring procedures and tools for investigator-initiated (IND) or IDE-enabling clinical trials.
  • Conducts and documents assigned periodic monitoring according to the monitoring plan.
  • Verifies validity of research results by ensuring timely, accurate, and complete source data and Case Report Form documentation.
  • Participates in the preparation and follow-up activities for regulatory agency and Sponsor audits.
  • Plans and writes materials for IRB submissions.
  • Submits and tracks regulatory documents in the clinical trials management system (CTMS).

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
  • 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.
  • Excellent oral and written communication skills
  • Strong customer service skills
  • Strong work processing skills and understanding.
  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations with a keen attention to detail.
  • Valid driver’s license.
Benefits
  • 37.5-hour work week
  • 13 paid holidays
  • 24 annual leave (vacation) days per year
  • 18 sick days per year
  • WVU offers a range of health insurance and other benefits
  • 401(a) retirement savings with 6% employee contribution match
  • Wellness programs
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
monitoring proceduressource data verificationCase Report Form documentationregulatory document submissionclinical trials management system (CTMS)investigational new drug (IND) applicationsabbreviated new drug applications (ANDA)premarket approval (PMA)in vitro diagnostics (IVD) safety reportsregulatory compliance
Soft Skills
oral communicationwritten communicationcustomer serviceattention to detail
Certifications
Bachelor's degree