Quality and Compliance Assessor

Job Summary :

The Quality and Compliance Assessor collaborates with Clinical Research Associate (CRA) line management to perform quality oversight activities, ensuring consistent, high-quality performance in clinical trials. The role involves monitoring, auditing, analyzing oversight data, and providing guidance to improve operational quality across multiple projects and regions.

Key Responsibilities :

• Perform Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and / or Sign-Off Visits (SOVs) as assigned.
• Analyze qualitative oversight data to identify quality improvement signals.
• Conduct root cause analysis of quality signals and develop action plans to implement process and efficiency improvements.
• Identify training needs for CRAs based on aggregated oversight data to meet quality and efficiency standards.
• Conduct training sessions in collaboration with Learning Center of Excellence, Corporate Quality, and Clinical Operations Management.
• Support Clinical Operations in resolving ad hoc or escalated quality concerns within the region.
• Act as a consultant to local / regional operations regarding quality oversight best practices and tools.
• Assist in reviewing Clinical Monitoring SOPs, tools, or templates related to monitoring oversight.
• Perform other work-related duties as assigned.

Qualifications :

Skills Required

Quality Assurance, Regulatory Compliance, Risk Management, Data Analysis, Process Improvement