Clinical Regulatory Coordinator

Job Description

We are seeking a Clinical Regulatory Coordinator to manage, submit, and maintain regulatory documents for IRB and sponsor submissions across multiple studies. This role involves ensuring all study documentation complies with GCP, FDA regulations, and institutional policies.

Responsibilities

• Manage, submit, and maintain regulatory documents for IRB and sponsor submissions across multiple studies.
• Ensure all study documentation complies with GCP, FDA regulations, and institutional policies.
• Maintain regulatory binders and essential study documentation across all active and archived studies.
• Track protocol amendments, safety reports, and correspondence with regulatory bodies.
• Coordinate and support site initiation visits, monitoring visits, audits, and inspections from a regulatory perspective.
• Work collaboratively with clinical and operations staff to ensure timely startup and regulatory readiness.
• Assist in developing SOPs and regulatory workflows to support regulatory operations.
• Provide on-site regulatory support for trial sites during SIVs, monitoring visits, and other ad hoc visits as needed.

Required Skills

• 4+ years of experience in clinical research regulatory coordination.
• Deep understanding of FDA regulations, GCP, and IRB processes.
• Experience completing internal/external audits.
• Strong organizational skills and attention to detail.
• Ability to manage multiple studies and deadlines simultaneously.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office and electronic regulatory systems.
• Willingness and ability to travel (up to 25%) across sites.

Work Environment

This role requires 100% on-site presence with up to 25% travel between sites in LA, Las Vegas, Texas, and DC. Travel planning is provided with a 2-week advance notice.