The position of Regulatory Coordinator Assistant reports directly to the Clinical Trials Manager or Director of Clinical Trials and Regulatory Affairs. Regulatory Coordinators interface with Study Monitors and Project Coordinators from Sponsors, Clinical Research Organizations (CROs), and Institutional Review Boards (IRBs), and with CIS clinical research staff.
Responsibilities
The primary responsibility of this position is to complete regulatory documents such as Form FDA 1572, Financial Disclosure Forms (FDFs), IRB initial submissions and site status reports, and to submit these to the Sponsor/CRO and/or IRB for approval, as applicable, and conduct follow-up as necessary.
- Complete initial regulatory packet for submission to Sponsors/CROs
- Complete and submit initial, interim, and closeout reports for all study protocols to IRBs
- Maintain trial master files
- Interface with site monitors as needed
- Prepare and Submit any protocol deviations, SAE’s to the IRB in a timely manner
- Assist the clinical team as needed with patient care assignments
- Complete and maintain Delegation of Authority logs
- Maintain credentialing & licensing of all relevant staff
- Maintain, draft and distribute new and revised Standard Operating Procedures (SOP’s)
- Track Investigator and staff protocol training
- Expedite study start up
- Miscellaneous assignments as directed
Qualifications
- Self-directed
- High attention to detail
- Intermediate to advanced computer skills
- Professional phone and communication skills
- Basic knowledge/experience in record audits
- Ability to conduct quality assurance reviews
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