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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Clinical Investigation Specialists (CIS)

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Regulatory Affairs Coordinator Assistant