Clinical Site Compliance Specialist

2 days ago


belgaum, India beBeeAudit Full time

Job OverviewClinical site auditors play a crucial role in ensuring compliance and quality at clinical trial sites.Conduct thorough audits of research sites across phases I–IV to identify potential issues.Review case report forms, informed consent documents, and regulatory materials to ensure accuracy and adherence.Identify and document audit findings; recommend targeted corrective actions to prevent non-compliance.Provide support and guidance to site staff on compliance best practices and training needs.Prepare comprehensive audit reports and follow up on implementation of corrective action plans.Key Skills:Strong knowledge of Good Clinical Practice (GCP) guidelinesUnderstanding of FDA/EMA regulations and industry standardsExperience with electronic Trial Master File (eTMF) and Electronic Data Capture (EDC) systems



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