Senior Regulatory Coordinator

Job Summary

A company is looking for a Senior Regulatory Coordinator.

Key Responsibilities

• Lead regulatory oversight for clinical trials, ensuring compliance with institutional and federal guidelines
• Maintain accurate electronic regulatory binders and essential study documents for audits and monitoring visits
• Serve as a primary regulatory liaison between investigators, research teams, sponsors, and regulatory agencies

Required Qualifications

• Associates degree with 5 years of relevant experience, or Bachelor's degree with 3 years of relevant experience
• Working knowledge of clinical trials and relevant regulations, including IRB requirements
• Experience in protocol and consent form development
• Ability to provide training and operational guidance to research staff
• Experience in process improvement initiatives within clinical research settings