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).

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.

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

Key skills