Clinical Trials Compliance Expert

1 week ago


vijayawada, India beBeeQuality Full time

Quality Assurance SpecialistTo ensure high-quality outcomes in clinical trials, we seek a meticulous Quality Assurance Specialist. As a key member of our team, you will conduct rigorous site audits, review documentation, and verify adherence to strict protocols and regulatory requirements.Conduct thorough audits of clinical research sites across various trial phases.Analyze CRFs, informed consent forms, and other critical documents for compliance.Identify and report any discrepancies or non-compliance issues; provide actionable recommendations for corrective actions.Offer guidance and training to site staff on quality assurance best practices and regulatory standards.Publish comprehensive audit reports and follow up on the implementation of corrective actions.Essential Requirements:Bachelor's degree in life sciences, nursing, pharmacy, or a related field.A minimum of 10-12 years of experience in clinical research, with a strong background in auditing and quality assurance.In-depth knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Excellent communication, analytical, and organizational skills.Ability to travel is required for this role.



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