Clinical Research Site Auditor

7 days ago


vellore, India beBeeAuditor Full time

Key Audit RolesWe seek a seasoned professional to lead site audits, ensuring compliance with regulatory requirements and maintaining the highest standards in clinical research.Audit clinical research sites across phases I–IV, reviewing CRFs, informed consent forms, and regulatory documents.Identify and report audit findings; recommend corrective actions to ensure optimal results.Key Performance Indicators: Effective audit management, high-quality audit reports, client satisfaction, continuous process improvement.Essential Qualifications:Proven experience in clinical research and auditing, knowledge of GCP, ICH guidelines, and FDA/EMA regulations, strong analytical and organizational skills, ability to travel required. Possess effective communication and interpersonal skills to collaborate with site staff and stakeholders.Clinical Research or Quality Auditing certification (ACRP, SOCRA).Experience with eTMF and EDC systems.History of conducting multi-center or global trials.



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