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.