GCP Auditor

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

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

Disclaimer

Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.

We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.