Clinical Research Associate II – Site Monitoring

About the role

The Clinical Research Associate II (FSP) will support study teams by driving study performance at investigative sites. You will conduct site monitoring visits, ensure compliance with ICH‑GCP and local regulations, and act as a key liaison between the sponsor and site staff.

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 local study teams.
• Assist in site and investigator selection, and provide training and support.
• Maintain essential documentation, manage study and drug supplies, and perform source data verification.
• Ensure timely data query resolution and collaborate with data management.
• Report serious adverse events accurately and promptly.
• Update VCV and other systems with site data as required.
• Prepare for audits and regulatory inspections in liaison with QA.
• Adhere to company code of conduct, policies, and required training.

Required profile

• Bachelor’s degree in biological science, healthcare, or a related field, or equivalent experience.
• Minimum 2 years of experience as a Clinical Research Associate, performing all CRA duties.
• Fluent oral and written English; proficiency in the host‑country language if applicable.
• Strong written and verbal communication, collaboration, and interpersonal skills.

Required skills

• Proficient use of Microsoft Office applications.