Senior Clinical Research Associate

About the role

The Senior Clinical Research Associate will perform monitoring and site management to ensure studies are conducted according to protocol, regulations and sponsor requirements.

Key responsibilities

• Conduct site monitoring visits (selection, initiation, monitoring, close‑out) following GCP and ICH guidelines.
• Drive and track subject recruitment plans with sites to meet project timelines.
• Provide protocol training, maintain communication, and manage study expectations.
• Evaluate site practices for quality and regulatory compliance, escalating issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries and support start‑up activities.
• Maintain Trial Master File and Investigator Site File documentation.
• Prepare visit reports, follow‑up letters and other required study documentation.

Required profile

• Bachelor’s degree in a scientific discipline or health care, or equivalent experience.
• At least 1 year of on‑site monitoring experience.
• Good knowledge of GCP and ICH clinical research regulations.
• Strong written and verbal English communication skills.
• Organizational, problem‑solving and time‑management abilities.

Required skills

• Proficiency in Microsoft Word.
• Proficiency in Microsoft Excel.
• Proficiency in Microsoft PowerPoint.