Clinical Research Associate

Overview

The Clinical Research Associate serves as the primary point of contact for investigative sites, driving effective site engagement and ensuring appropriate trial conduct.

What you'll do

• Coordinate site evaluation, training, routine monitoring, and site closure monitoring activities.
• Ensure trial activities comply with the protocol, monitoring plans, applicable regulations, GCPs, ICH guidelines, and quality standards.
• Use site engagement strategies and tools (including CRM) to gather insights and track progress and impact.
• Monitor site activities to detect early overall study performance or patient safety issues, proactively conducting risk assessment with the Central Monitoring team.
• Ensure data quality and timely submission from study sites, including follow-up for safety events.
• Support recruitment and retention by evaluating and recommending techniques/plans based on the patient disease journey.
• Maintain audit and regulatory inspection readiness at the assigned site.

What you'll need

• Preferred: tertiary qualification in a health-related discipline (Medical, Scientific, Nursing).
• Minimum: 1 year of clinically related experience.
• Minimum: 6 months in clinical research monitoring of investigational drug or device trials.
• Familiar with risk-based monitoring approaches (onsite and offsite).
• Advanced knowledge of local regulatory and legal requirements and ICH/GCP guidelines.
• Strong cross-functional collaboration, planning, and organizational skills in a dynamic environment.
• Strong interpersonal and communication skills, including written and verbal presentation.

Details

• Location: Shanghai, Shanghai, China.