Clinical Site Compliance Specialist

3 days ago


erode, India beBeeCompliance Full time

Compliance Specialist Job DescriptionAs a Clinical Site Compliance Specialist, you will be responsible for ensuring adherence to protocols, GCP, GLP, and regulatory requirements at clinical trial sites.Conducting site audits to verify compliance with regulations.Reviewing CRFs, informed consent forms, and regulatory documents.Identifying and reporting audit findings, and recommending corrective actions.Supporting site staff with compliance guidance and training.Preparing audit reports and following up on CAPA implementation.The ideal candidate should have a Bachelor's degree in life sciences, nursing, pharmacy, or a related field, and 10-12 years of clinical research experience with auditing and QA experience. Knowledge of GCP, ICH guidelines, and FDA/EMA regulations is essential. Strong communication, analytical, and organizational skills are also required.This role requires up to 50% travel to clinical sites and a combination of remote and field work. A flexible schedule is necessary to accommodate site audits.



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