Clinical Research Associate II – FSP

About the role

The Clinical Research Associate II (FSP) will support AstraZeneca study sites by conducting monitoring visits, ensuring compliance with ICH‑GCP and local regulations, and maintaining high‑quality study documentation.

Key responsibilities

• Perform site monitoring and onsite visit activities according to the monitoring plan.
• Prepare and submit monitoring visit reports within required timelines.
• Identify and escalate study‑related issues to the Local Study Team.
• Train and advise investigators and site staff on study procedures.
• Manage study supplies, drug accountability, and source data verification.
• Ensure timely reporting of serious adverse events and resolution of data queries.
• Support audit and regulatory inspection preparation.

Required profile

• Bachelor’s degree in biological science, healthcare or equivalent.
• Minimum 2 years of experience as a CRA or in a related clinical monitoring role.
• Strong knowledge of monitoring processes, study drug handling, and data management.
• Fluent oral and written English with solid communication and interpersonal skills.

Required skills

• Proficiency with Microsoft Office and related software.
• Knowledge of ICH‑GCP guidelines and local regulatory requirements.
• Experience with source data verification (SDV) and clinical data flow.