GCP Clinical Audit Consultant Medical Device Trials

GCP Clinical Audit Consultant – Medical Device Trials

Location: New York City, NY
Work Arrangement: Onsite
Duration: Approximately 21 hours total
Start: Fourth Quarter 2026
Schedule: Two-day onsite audit with additional planning, and report development
Travel: Local candidates preferred

We are seeking an experienced GCP Clinical Audit Consultant to conduct a routine Good Clinical Practice audit in New York City during the fourth quarter of 2026.

The consultant will provide independent clinical quality auditing support for a medical device clinical investigation, assessing study conduct, documentation, data integrity, and regulatory compliance. The engagement requires strong knowledge of GCP requirements applicable to medical device studies, including ISO 14155 and relevant U.S. FDA regulations.

The anticipated engagement includes approximately 21 total hours per auditor, consisting of audit planning and scheduling, required training, two days of onsite audit conduct, and audit report development and edits.

Experience auditing clinical studies involving psychiatric conditions and/or depression is highly desirable, whether within medical device or pharmaceutical development.

• Complete approximately one hour of audit scheduling and planning.

• Complete approximately one hour of required training per audit type, per auditor.

• Conduct approximately 16 hours of onsite audit activities over two days.

• Assess study conduct and documentation for compliance with applicable Good Clinical Practice requirements.

• Evaluate compliance with ISO 14155 requirements for clinical investigations of medical devices.

• Assess applicable U.S. regulatory requirements, including 21 CFR Parts 11 and 812.

• Evaluate relevant clinical data integrity, electronic records, and documentation practices.

• Assess compliance with applicable patient privacy requirements, including HIPAA.

• Identify and clearly document audit observations and potential compliance gaps.

• Communicate audit findings objectively and effectively to appropriate stakeholders.

• Complete approximately three hours of audit report development and edits following the audit.

• Demonstrated experience conducting GCP audits of medical device clinical trials.

• Strong knowledge of ISO 14155 and Good Clinical Practice requirements applicable to medical device investigations.

• Working knowledge of applicable U.S. FDA regulations, including 21 CFR Parts 11 and 812.

• Knowledge of clinical data privacy requirements, including HIPAA.

• Ability to independently conduct an onsite clinical audit and clearly document audit findings.

• Lead auditor certification in ISO 13485.

• Experience auditing psychiatric and/or depression clinical studies within the medical device or pharmaceutical industry.

This is a short-term engagement requiring approximately 16 hours of onsite audit conduct over two days in New York City during the fourth quarter of 2026. The engagement also includes approximately one hour of audit scheduling and planning, one hour of required training per audit type, per auditor, and three hours of audit report development and edits.

Local candidates are preferred.

The ideal consultant is an experienced clinical quality auditor with a strong background in GCP audits of medical device studies, practical knowledge of ISO 14155 and applicable FDA requirements, and prior exposure to psychiatric or depression clinical research.