GCP Auditor
October 31
Description
• Position Title: • GCP Auditor • Company Overview: • Stirling Q&R is looking for a detail-oriented and experienced GCP (Good Clinical Practice) Auditor to join our quality assurance team. • In this role, you will be responsible for assessing compliance with GCP guidelines and regulatory requirements, ensuring the integrity and reliability of clinical trial data. • Key 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.
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). • Familiarity with electronic data capture (EDC) systems.
Benefits
• Private Health Insurance • Pension Plan • Work From Home
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