Clinical Compliance Specialist

2 weeks ago


bareilly, India beBeeAuditor Full time

Job Title: Clinical Quality Compliance ManagerLocation: Bengaluru, Karnataka, IndiaReports To: QA/Compliance Director or Clinical Operations DirectorJob Summary:Our team seeks a highly skilled Clinical Site Auditor to ensure compliance and quality at clinical trial sites. The ideal candidate will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP, and regulatory requirements.Key Responsibilities:Conduct thorough audits of clinical research sites across phases I–IV.Review case report forms (CRFs), informed consent forms, and regulatory documents.Identify and report audit findings; recommend corrective actions.Support site staff with compliance guidance and training.Prepare detailed audit reports and follow up on CAPA implementation.Qualifications:Bachelor's degree in life sciences, nursing, pharmacy, or related field.10-12 years of clinical research experience, with auditing and QA experience.Knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and FDA/EMA regulations.Strong communication, analytical, and organizational skills.Able to travel as required.Preferred:Clinical Research or Quality Auditing certification (ACRP, SOCRA).Experience with electronic Trial Master File (eTMF) and Electronic Data Capture (EDC) systems.Experience auditing multi-center or global trials.Working Conditions:Up to 50% travel to clinical sites.Combination of remote and field work.Flexible schedule to accommodate site audits.



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