Quality Assurance Specialist

Hassman Research Institute (HRI) 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-conformances with requirements.
• 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 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:

• Minimum Education Required – Bachelor’s Degree
• 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 plus years in work related to Quality Assurance area in clinical research.
• Experience including external clinical/regulatory and document auditing desirable.
• Ability in the administration, and interpretation of protocols as directed by sponsor

All your information will be kept confidential according to EEO guidelines.