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Clinical Research Regulatory Associate

Arrow Clinical Trials • Daytona Beach, FL, US • published 2026-09-25 21:51:46.177208

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Description

**Overview** Position Summary The Regulatory Associate supports the regulatory and administrative activities necessary for the initiation, conduct, maintenance, and closeout of clinical research studies. This position works closely with investigators, study coordinators, sponsors, CROs, IRBs, and internal staff to ensure regulatory documentation is complete, accurate, organized, and maintained in accordance with study requirements, Good Clinical Practice (GCP), and applicable regulations. Essential Duties and Responsibilities * Prepare, collect, review, and maintain regulatory documents for clinical research studies. * Assist with initial study submissions, amendments, continuing reviews, safety reports, and study closeouts to Institutional Review Boards (IRBs). * Maintain regulatory binders and electronic regulatory files throughout the life of each study. * Collect and maintain investigator and staff documents, including CVs, licenses, certifications, training records, financial disclosures, and delegation\-related documentation. * Assist with FDA Form 1572 preparation and maintenance, when applicable. * Track regulatory document expiration dates and obtain updated documents in a...


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