The Regulatory Specialist is responsible for ensuring that the site complies with and adheres to the procedures and processes set forth in the Standard Operating Procedures. This is accomplished in part by the following duties as well as the ability to maintain a high level of prioritizing and continued knowledge of study status.
Responsibilities
- Site liaison with Institutional Review Boards (IRB) including new study and amendment submissions, annual and close-out reports/reviews, deviation and AE/SAE notifications
- Initial Study Submission documentation to sponsors completed within allowed time frame
- Processing and distribution of IND safety reports, following procedures detailed in SOPs
- Responsible for creating Training Documentation for new studies, amendments, new staff, and staff newly assigned to the study transfer
- Maintaining site Delegation of Authority Logs – addition of new study staff and removal of staff members no longer associated with the study
- Responsible for DEA 222 forms – ordering the forms, tracking and sending to FDA as needed
- CV maintenance
- Prepare and complete sponsor required documentation for new study initiations as well as close-out visits and audits
- Interact with study Monitors preparing for their regular visits including filing, follow-up, and resolving any specific issues
- Tracking of protocol Amendment and Investigator Brochure receipt including PI signature and IRB approval following procedure in SOP
- Tracking and distribution of all informed consents including new study and revisions per procedures listed in SOP
- Circulating of study-related emails and correspondence within site
- Maintenance of current studies – 1572 revisions, returning miscellaneous items to sponsors/CROs, etc.
- Archiving closed studies and preparation for shipment to off-site storage facilities
Knowledge, Skills and Abilities
- Ability and willingness to work independently with minimal supervision.
- Excellent communication skills and a high degree of professionalism
- Knowledge of medical terminology
- Exceptional organizational skills with a strong attention to detail
- Ability to critically think and problem solve
- Maintain professionalism during all circumstances
- Friendly, dynamic personality; maintain a positive attitude under pressure
- Contribute to team goals
Job Type: Full-time
Pay: $40,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Education:
Experience:
- Clinical research: 1 year (Preferred)
- Regulatory: 1 year (Preferred)
Work Location: In person
