Clinical Research Compliance Specialist

19 hours ago


amravati, India beBeeCompliance Full time

Job Title:Clinical Research Compliance SpecialistWe are seeking a skilled Clinical Research Compliance Specialist to ensure adherence to regulatory requirements and quality standards at Clinical Trial sites.Key Responsibilities:Conduct audits of clinical research sites across phases I–IV, reviewing CRFs, informed consent forms, and regulatory documents. Identify and report audit findings; recommend corrective actions. Provide compliance guidance and training to site staff. 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.Benefits:The ideal candidate will possess excellent communication skills, strong attention to detail, and the ability to work effectively in a team environment.Other Requirements:A portfolio of previous audit reports and experiences would be an asset for this position.



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