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.