Clinical Data Coordinator

Job responsibilities

• Manage regulatory activities from study start-up through close-out
• Prepare, submit, and maintain IRB applications, amendments, continuing reviews, and closures
• Maintain complete, audit-ready regulatory binders (eISF/ISF)
• Track essential documents, training logs, and delegation records
• Support EDC data entry, source documentation review, and quality control
• Resolve data queries and support reconciliation between source and EDC
• Serve as a regulatory and data point of contact for sponsors, CRAs, and IRBs
• Ensure ongoing site compliance and inspection readiness

Job requirements

• 2+ years of experience in clinical research regulatory and/or data coordination
• Hands-on experience submitting to and working directly with IRBs
• Familiarity with EDC systems and source documentation standards
• Strong understanding of ICH-GCP and site regulatory requirements
• Ability to manage studies independently from start-up to close-out
• Highly organized, detail-oriented, and able to manage multiple priorities
• Experience with eReg systems (CRIO, Florence, Veeva, or similar) preferred

Skills

• IRB Submissions
• Study Start-Up
• Regulatory Maintenance
• EDC Data Entry
• Source Documentation QC

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