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Regulatory Affairs Specialist

BRCR Global • Coral Springs, FL, US • published 2026-10-06 19:33:47.439014

Description

The Regulatory Affairs Specialist plays a crucial role in the clinical trial process by giving support and overseeing the daily regulatory activities by ensuring compliance with relevant regulations. **Principal Responsabilities:** * Prepare and maintain complete and accurate regulatory documents in support of clinical research studies. * Manage all the communication with the IRB and Sponsor. * Prepare each study\-specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. * Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB\-required submissions. * Work with staff members to complete Financial Disclosure Forms for each study. * Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed. * Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to always ensure audit readiness. * Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by...

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