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.
