Quality Assurance Associate

A Quality Assurance Associate will support quality functions at CenExel HRI inpatient/outpatient locations.

Essential Job Functions:

  • Attend all SIVs (as required)
  • Assist QA Director in reviewing source doc templates prior to use, to ensure protocol requirements are followed
  • Review study docs for accuracy and compliance under the guidance of the Quality Assurance Director
  • Ensure data is recorded in accordance with sponsor protocol, GCP guidelines, industry guidelines and agency regulations
  • Perform quality control checks; identify and track source documentation errors and non-conformances with requirements
  • Assist in the preparation of reports for submission to regulatory authorities
  • Serve as resource to Research Assistants in tasks related to quality control
  • Assist QA Director in ensuring the study team addresses all monitoring reports appropriately
  • Work with the site’s regulatory department to accumulate accurate information for generating notes to file and for timely submission to IRB
  • Assist in preparing for all Sponsor and FDA audits
  • Assist in conducting internal audits to review key processes within CenExel HRI
  • Assist with the maintenance and retention of training and certification records
  • Ensure SOP/WI training documents are kept on file and up to date, as per company policies
  • Other related Quality Assurance projects as assigned

Knowledge, Education, and Experience:

  • Bachelor’s Degree required
  • In-depth knowledge of FDA, GCP, ICH, and other state and federal agency guidelines for the conduct of clinical trials
  • Knowledge of IRB requirements
  • Knowledge of HIPAA Privacy Act and its application to clinical research
  • 3+ years in work related to Quality Control / Quality Assurance area in clinical research
  • Experience including external clinical/regulatory and document auditing desirable

Job Category: Quality Assurance

Job Type: Full Time

Job Location: BerlinMarlton

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