Clinical Research Associate - III

About the role

The Clinical Research Associate – III provides clinical support to the Global Clinical Operations site management team. Working under limited supervision, the role ensures that study protocols are executed in line with standard operating procedures, ISO/GCP standards and applicable regulatory requirements.

Key responsibilities

• Act as the primary liaison between the Study Core Team and the monitoring team, facilitating communication of monitoring updates, site‑level risks and action items.
• Coordinate follow‑up on monitoring‑related questions, documentation needs and study‑specific guidance to ensure consistent execution across sites.
• Perform lead monitor tasks such as remote qualification, initiation, monitoring and close‑out visits.
• Conduct source verification by comparing case report form data with source documents, reviewing informed consent forms, regulatory documents and device accountability records.
• Prepare and distribute clear written communications including monitoring reports, follow‑up letters and study memos.
• Support site personnel training, maintain qualification records and ensure compliance with protocol and regulations.
• Identify, document and escalate non‑compliance issues, and support internal and external audit activities.
• Report all adverse and other reportable events according to protocol and regulatory requirements.

Required profile

• Experience in clinical research monitoring and site management.
• Familiarity with ISO/GCP standards and regulatory requirements for clinical trials.
• Ability to work under limited supervision while following general instructions.
• Strong written communication skills for interaction with sites and internal teams.

Required skills

• ISO/GCP compliance
• Source verification
• Regulatory document review