Good Clinical Practice (GCP) Auditor

On-Site Role

Compensation: $70 - $90/hr

ABOUT THE ROLE

Our client is seeking an experienced Good Clinical Practice (GCP) Auditor to ensure clinical research compliance within a leading medical device organization. In this critical role, you will ensure that all clinical activities conducted by the company, its sites, and its vendors comply with GCP, regulatory requirements, and internal quality standards. The GCP Auditor will be responsible for planning and conducting internal and vendor audits, reviewing clinical documentation for compliance, and identifying and addressing quality risks. You will provide GCP guidance to cross-functional teams, support clinical site qualification and monitoring, and prepare teams for regulatory inspections. Additionally, you will contribute to the development and maintenance of quality systems, drive continuous improvement initiatives, and support inspection readiness and remediation activities to uphold the highest standards of clinical research quality and regulatory compliance.

WHAT YOU'LL DO

• Plan, schedule, and conduct internal GCP audits of clinical trials, processes, systems, and documentation
• Perform vendor audits (CROs, labs, investigative sites) to assess GCP compliance and quality risks
• Review clinical documentation for compliance gaps, including protocols, monitoring plans, informed consent forms, trial master files (TMFs), case report forms (CRFs), and regulatory submissions
• Identify, document, and communicate audit findings; develop and track corrective and preventive actions (CAPAs) in collaboration with cross-functional partners
• Provide GCP guidance to Clinical Affairs, Regulatory, Quality, and Operations teams
• Support clinical site qualification, initiation, and ongoing monitoring from a quality perspective
• Partner with Clinical Operations to ensure adherence to protocol requirements and applicable regulations
• Prepare teams and documentation for FDA, EU Notified Body, and other regulatory inspections
• Conduct mock inspections and readiness assessments for upcoming clinical milestones
• Support remediation efforts and follow-up activities post-inspection
• Contribute to the development and maintenance of standard operating procedures (SOPs), work instructions, and quality standards related to clinical research
• Trend audit outcomes to identify systemic issues and drive continuous improvement in quality systems
• Support risk mitigation and inspection readiness across clinical programs

WHAT YOU BRING

• Bachelor’s degree in life sciences, pharmacy, nursing, or related field
• Extensive knowledge of Good Clinical Practice (GCP) guidelines and clinical research regulations (FDA, ICH, EU, etc.)
• Proven experience conducting internal and vendor GCP audits in a clinical research or medical device environment
• Strong understanding of clinical trial processes, documentation, and regulatory submissions
• Experience preparing for and supporting regulatory inspections (FDA, EU Notified Body, etc.)
• Ability to develop, implement, and maintain SOPs, work instructions, and quality standards
• Excellent communication, documentation, and cross-functional collaboration skills
• Strong analytical, problem-solving, and risk assessment abilities
• Attention to detail and commitment to continuous improvement

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