Quality Assurance Specialist

5 days ago


thrissur, India beBeeClinical Full time

Key to ensuring the quality and integrity of clinical trials is a thorough audit process. In this role, you will be responsible for conducting site audits to verify compliance with regulatory requirements and industry standards.Responsibilities:Audit sites to ensure adherence to Good Clinical Practice (GCP) guidelines and protocols.Evaluate clinical trial documentation, including case report forms (CRFs) and informed consent forms.Determine and document any non-compliance issues, recommending corrective actions as necessary.Support site staff in understanding and adhering to regulatory requirements.Prepare comprehensive audit reports outlining findings and recommendations.Requirements:Bachelor's degree in life sciences, nursing, pharmacy, or a related field.10-12 years of experience in clinical research, with a focus on auditing and quality assurance.Knowledge of GCP, ICH guidelines, and FDA/EMA regulations.Excellent analytical, communication, and organizational skills.Ability to travel is required for site visits.



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