Senior Clinical Research Associate – Clinical Trials

About the role

Parexel FSP is expanding its clinical research team and is looking for experienced Senior Clinical Research Associates (CRAs) to manage study sites across multiple therapeutic areas. The CRA will act as the primary liaison between the sponsor and the investigative sites, ensuring that studies are conducted in compliance with ICH‑GCP, local regulations, and sponsor SOPs.

Key responsibilities

• Identify and qualify potential investigators; support site start‑up and regulatory submissions.
• Train and advise investigators and site staff on study protocols, ICH‑GCP, and Risk‑Based Quality Management principles.
• Perform monitoring visits (on‑site and remote), source data review, case report form verification, and source data verification according to the monitoring plan.
• Maintain up‑to‑date records in the CTMS, manage study supplies, and ensure drug accountability.
• Track patient recruitment, assess site performance, and proactively resolve study‑related issues.
• Prepare and close out sites, ensuring all documentation is complete and inspection‑ready.

Required profile

• Minimum 3‑5 years of experience as a Clinical Research Associate in pharmaceutical or CRO environments.
• Strong knowledge of ICH‑GCP, local regulatory requirements, and risk‑based monitoring.
• Excellent communication skills and ability to work collaboratively with cross‑functional teams.
• Detail‑oriented with strong organizational and problem‑solving abilities.

Required skills

• ICH‑GCP compliance
• Risk‑Based Quality Management (RbQM)
• Clinical Trial Management System (CTMS) usage
• Source Data Review (SDR) and Source Data Verification (SDV)
• Regulatory submission processes
• Investigator Site File (ISF) management