Senior Clinical Research Associate

About the role

We are seeking an experienced Senior Clinical Research Associate to join our clinical monitoring team at COMAC MEDICAL. The role focuses on driving successful clinical trial execution through high-quality site conduct and fostering positive investigator relationships.

Key responsibilities

• Lead feasibility assessments and site qualification activities.
• Build and maintain collaborative relationships with investigators and site staff.
• Develop in-depth knowledge of study protocols and operational procedures.
• Support essential documentation such as protocols, CRFs, and regulatory files.
• Conduct on-site and remote monitoring to ensure compliance and patient safety.
• Oversee recruitment, retention, protocol deviations, and inspection readiness.
• Identify and resolve performance or quality concerns proactively.
• Partner with study leadership to escalate and manage issues.
• Contribute to investigator meetings and study-related events.

Required profile

• Bachelor’s or Master’s degree in Life Sciences (e.g., Biology, Pharmacy, Chemistry).
• Minimum 3 years of independent monitoring experience as a CRA.
• Strong understanding of ICH‑GCP, clinical operations, and local regulatory standards.
• Excellent planning, prioritization, and relationship-building abilities.
• Analytical mindset with effective troubleshooting skills.
• Proactive attitude and accountability in a fast-moving environment.
• Willingness to travel up to 30%.
• Professional fluency in English.

Required skills

• Knowledge of ICH‑GCP guidelines.
• Familiarity with clinical trial monitoring processes.
• Proficiency with MS Office tools.

What we offer

• Opportunity to work on complex, multi-phase studies across therapeutic areas.
• Career development and clear progression pathways.
• Internationally diverse, supportive team environment.
• Exposure to advanced Phase I expertise and full-service global solutions.