Regulatory Coordinator

Job responsibilities

• Lead regulatory activities from study start-up through close-out
• Prepare and submit IRB applications, amendments, continuing reviews, and closures
• Maintain complete, inspection-ready regulatory binders (eISF/ISF)
• Manage essential documents, delegation logs, and training documentation
• Serve as the primary regulatory point of contact for sponsors, CRAs, and IRBs
• Ensure ongoing site compliance and readiness throughout the study lifecycle

Job requirements

• 2+ years of experience in clinical research regulatory operations
• Hands-on experience submitting to and working directly with IRBs
• Strong understanding of ICH-GCP and site regulatory requirements
• Proven ability to manage studies independently from start-up to close-out
• Experience with eReg systems (CRIO, Florence, Veeva, or similar) preferred

Skills

• IRB submissions & regulatory strategy
• Study start-up and close-out management
• eISF / regulatory document control
• Sponsor & CRA communication
• Detail-oriented, highly organized, self-directed

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