GCP Auditor: Clinical Compliance & Audit Leader

Medasource; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Medasource is seeking an experienced Good Clinical Practice (GCP) Auditor to ensure regulatory compliance across clinical activities, sites, and vendors within a leading medical device organization. You will plan internal and vendor audits, review documentation, and drive CAPAs with cross-functional teams to uphold quality and readiness for inspections.

You will provide GCP guidance, support site qualification and monitoring, and help maintain SOPs and quality systems while contributing to

Qualifications

• 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.

Responsibilities

• 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, TMFs, CRFs, and regulatory submissions
• Identify, document, and communicate audit findings; develop and track 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 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

Skills

GCP guidelines knowledge

Regulatory compliance

Audit experience

Documentation skills

Cross-functional collaboration

Risk assessment

Attention to detail

Education

Bachelor’s degree in life sciences, pharmacy, nursing, or related field

Job description

Medasource is seeking an experienced Good Clinical Practice (GCP) Auditor to ensure regulatory compliance across clinical activities, sites, and vendors within a leading medical device organization. You will plan internal and vendor audits, review documentation, and drive CAPAs with cross-functional teams to uphold quality and readiness for inspections.

You will provide GCP guidance, support site qualification and monitoring, and help maintain SOPs and quality systems while contributing to