Job Description

Roles & Responsibilities

• Conduct thorough audits of clinical trial data, ensuring accuracy, completeness, and adherence to protocols and regulations, meticulously examining source documents and electronic data capture systems.
• Verify patient safety and data integrity by assessing adverse event reporting, protocol deviations, and laboratory data, focusing on potential risks and inconsistencies.
• Evaluate clinical trial sites for compliance with Good Clinical Practice (GCP) guidelines, identifying areas for improvement in site operations and data management processes.
• Prepare comprehensive audit reports, clearly documenting findings, observations, and recommendations for corrective actions, providing evidence-based insights.

Desired Candidate Profile

• A Bachelor's degree in a relevant field such as Biology, Pharmacy, or a related healthcare discipline, providing a strong foundation in scientific principles.
• Demonstrated experience in clinical research or a related field, showcasing a practical understanding of clinical trial processes.
• Relevant certifications such as Certified Clinical Research Professional (CCRP) or Certified Quality Auditor (CQA), demonstrating commitment to quality and expertise.
• Minimum of 3-5 years of experience in clinical research, auditing, or a related field, providing a solid understanding of clinical trial methodologies.
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