Quality Assurance Specialist

Hassman Research Institute is a leading clinical research organization conducting studies in a wide variety of therapeutic areas. HRI’s highly trained and experienced staff are dedicated to maintaining the highest standard of quality in the trials they conduct.

Essential Job Functions:

  • Assist QA Director in reviewing source doc templates prior to use, to ensure protocol requirements are followed.
  • 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-conformance with requirements.
  • Serve as a 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 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.

Job Category: Quality

Job Type: Full Time

Job Location: BerlinMarlton

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