Clinical Research Compliance Specialist

5 days ago


anand, India beBeeClinicalAudit Full time

Quality Assurance AuditorWe are seeking a Quality Assurance Auditor to ensure compliance and quality at clinical trial sites. This role involves conducting site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP and regulatory requirements.Conduct audits of clinical research sites across phases I–IV.Review CRFs, informed consent forms, and regulatory documents.Identify and report audit findings; recommend corrective actions.Support site staff with compliance guidance and training.Prepare audit reports and follow up on CAPA implementation.To be successful in this role, you will require: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 GCP, ICH guidelines, and FDA/EMA regulations.Strong communication, analytical, and organizational skills.Ability to travel is required.Prior experience with eTMF and EDC systems is an advantage, as is certification in Clinical Research or Quality Auditing (ACRP, SOCRA). Experience auditing multi-center or global trials is also highly valued.This position requires up to 50% travel to clinical sites. The ideal candidate will have a flexible schedule to accommodate site audits and will be comfortable working remotely and in the field.



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