GCP Auditor

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Requirements:

• Bachelor's degree in life sciences, nursing, or a relevant field; advanced degree preferred.
• 5+ years of experience in clinical research, quality assurance, or auditing, with a focus on Good Clinical Practice.
• Proven experience conducting GCP audits in clinical trials.
• Strong analytical skills with attention to detail.
• Excellent written and verbal communication abilities.
• Ability to work independently and effectively manage multiple audits simultaneously.
• Knowledge of relevant regulatory requirements and guidelines (FDA, EMA, ICH).
• Certification in Clinical Research or Quality Assurance (e.g., ACRP, ASQ) is desirable.
• Familiarity with electronic data capture (EDC) systems is desirable.

Responsibilities:

• Conduct comprehensive audits of clinical sites, clinical trials, and study systems to assess compliance with GCP, applicable regulations, and internal SOPs.
• Develop audit plans, execute audits, and prepare detailed audit reports summarizing findings, conclusions, and recommendations.
• Collaborate with clinical and regulatory teams to address audit findings and develop corrective action plans.
• Monitor the implementation of corrective actions and ensure timely resolution of identified issues.
• Provide training and guidance to staff on GCP compliance and quality assurance practices.
• Stay updated on changes to GCP regulations and trends in the clinical research industry.
• Assist in regulatory inspections and support responses to regulatory queries related to audit findings.