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Regulatory Coordinator - Clinical Research

Aqualane Clinical Research • Naples, FL, US • published 2026-09-25 21:51:46.178943

Description

**Job Overview** We are seeking a highly motivated and detail\-oriented Regulatory Coordinator specializing in Clinical Research to join our dynamic team. In this pivotal role, you will oversee the regulatory aspects of clinical trials, ensuring compliance with industry standards and government regulations. Your expertise will facilitate smooth study operations, support clinical development processes, and uphold the highest standards of research integrity. This position offers an exciting opportunity to contribute to groundbreaking healthcare advancements while working in a collaborative, fast\-paced environment committed to excellence. **Responsibilities** * Manage and maintain regulatory documentation for clinical trials, including submission packages, ethics committee approvals, and regulatory agency filings. * Review and verify clinical trial documentation for accuracy, completeness, and compliance with FDA regulations, ICH GCP guidelines, and other applicable standards. * Coordinate with study teams to ensure timely submission of regulatory documents and monitor ongoing compliance throughout the trial lifecycle. * Assist in preparing for audits and inspections by regulatory au...

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