Good Clinical Practice (GCP) Auditor

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a GCP auditor to join our amazing team. 

Job Title: Good Clinical Practice (GCP) Auditor

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview: We are seeking a qualified and experienced freelance GCP (Good Clinical Practice) Auditor to join our team. The ideal candidate will possess a strong background in clinical research, regulatory compliance, and GCP standards. As a freelance auditor, you will be responsible for conducting independent assessments of clinical trials and research studies to ensure compliance with GCP guidelines, applicable regulations, and sponsor requirements.

Responsibilities:

• Perform comprehensive audits of clinical trial sites, investigator sites, contract research organizations (CROs), and other entities involved in clinical research.
• Review study protocols, informed consent forms, case report forms (CRFs), and other essential documents to assess compliance with GCP standards and regulatory requirements.
• Evaluate the conduct of clinical trials, including subject recruitment, eligibility criteria, study procedures, data collection, and adverse event reporting.
• Verify the adequacy of site facilities, equipment, and personnel training to ensure the safety and integrity of study participants and data.
• Assess the quality and completeness of trial documentation, including study records, source documents, and regulatory submissions.
• Identify deviations, non-compliance issues, and areas for improvement during audits, and collaborate with stakeholders to develop corrective and preventive action plans.
• Prepare detailed audit reports documenting findings, observations, and recommendations for corrective actions, and ensure timely follow-up to verify implementation.
• Stay informed about changes in GCP regulations, industry guidelines, and best practices, and guide stakeholders on compliance requirements.
• Communicate effectively with study sponsors, investigators, study coordinators, and other relevant personnel to facilitate audit activities and promote compliance awareness.
• Maintain confidentiality and integrity throughout the audit process, adhering to ethical standards and professional conduct.

Requirements:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in clinical research, including a minimum of 5 years working in clinical trials management, monitoring, or auditing.
• In-depth knowledge of GCP regulations (e.g., ICH E6), FDA regulations, and other relevant guidelines governing clinical research.
• Proven experience conducting GCP audits, either as an internal auditor, sponsor representative, or independent consultant.

This is a remote freelance position with the possibility of occasional travel for on-site audits.