Clinical Research Auditor

2 weeks ago


kolkata, India beBeeQuality Full time

Job Title: Clinical Research AuditorJob Description:In this critical role, you will be responsible for ensuring compliance and quality at Clinical Trial sites by conducting thorough site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Conduct regular audits of clinical research sites across phases I–IV.Review case report forms (CRFs), informed consent forms, and other regulatory documents.Identify and report any audit findings; provide recommendations for corrective actions.Offer support to site staff on compliance guidance and training.Promote a culture of quality assurance throughout the organization.Required Skills and Qualifications:Bachelor's degree in life sciences, nursing, pharmacy, or a related field.Minimum 10 years of clinical research experience, with a strong background in auditing and QA.Familiarity with GCP, ICH guidelines, and FDA/EMA regulations.Excellent communication, analytical, and organizational skills.Ability to travel is required.



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