Clinical Research Auditor

6 days ago


nashik, India beBeeClinicalResearch Full time

Job Profile: Clinical Research AuditorThe Clinical Research Auditor is responsible for ensuring compliance and quality at clinical trial sites by conducting site audits, reviewing documentation, and verifying adherence to protocols, regulations, and standards.Main Responsibilities:Conduct thorough audits of clinical research sites across different phases.Review case report forms (CRFs), informed consent documents, and regulatory papers.Identify and document audit findings; provide recommendations for corrective actions.Offer guidance and training to site staff on compliance matters.Prepare detailed audit reports and follow up on the implementation of corrective actions.Key Qualifications:Bachelor's degree in a life science, nursing, pharmacy, or related field.Minimum 10-12 years of experience in clinical research, with expertise in auditing and quality assurance.Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and FDA/EMA regulations.Excellent communication, analytical, and organisational skills.Able to travel frequently for site audits.Working Conditions:Up to 50% travel to clinical sites.Combination of remote work and site visits.Flexible schedule to accommodate site audits.



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