Auditor of Clinical Research Sites

1 week ago


nadiad, India beBeeClinicalCompliance Full time

Clinical Compliance SpecialistAre you looking for a challenging role that allows you to ensure compliance and quality at Clinical Trial sites? As a Clinical Compliance Specialist, you will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP, and regulatory requirements.About the Role:Main Responsibilities: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.Requirements: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.Preferred Qualifications:Clinical Research or Quality Auditing certification (ACRP, SOCRA).Experience with eTMF and 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.We offer a dynamic work environment and opportunities for professional growth.



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