Senior Clinical Research Associate

About the role

This role is accountable for the performance and compliance of assigned clinical trial protocols and sites within the country. Under the oversight of the CRA Manager or Clinical Research Director, the incumbent ensures that study conduct complies with ICH/GCP guidelines, local regulations, company policies, quality standards, and adverse event reporting requirements.

Key responsibilities

• Develop and maintain strong relationships with investigators and study sites throughout all trial phases.
• Coordinate site start‑up activities and achieve Site Ready status in collaboration with cross‑functional teams.
• Conduct remote and on‑site monitoring visits to verify data completeness, accuracy and participant safety.
• Collect, review and maintain regulatory documentation for study start‑up, maintenance and close‑out.
• Communicate with investigators on protocol conduct, patient recruitment, deviations and regulatory requirements.
• Identify, assess and resolve site performance, quality and compliance issues, escalating when necessary.
• Support audit and inspection activities and perform quality‑control visits as delegated.
• Mentor junior CRAs and share best practices as a Subject Matter Expert.

Required profile

• Strong knowledge of ICH‑GCP, local regulations and clinical trial processes.
• Ability to independently manage multiple sites and competing priorities.
• Excellent communication and stakeholder‑management skills.
• Strong problem‑solving and risk‑assessment capabilities.
• Commitment to quality, compliance and patient safety.
• Effective collaboration in cross‑functional and global environments.

Required skills

• Clinical Data Management
• Clinical Trial Management
• Clinical Site Monitoring
• Pharmacovigilance
• Regulatory Document Management
• Patient Recruitment