Senior Clinical Research Associate (CRA) – Clinical Trials

About the role

We are looking for Senior Clinical Research Associates (or Clinical Research Associates) to join Parexel FSP’s clinical trial team. In this role you will be the primary contact for study sites, overseeing all phases from start‑up through closure while ensuring compliance with ICH‑GCP and local regulations.

Key responsibilities

• Select and qualify potential investigators and manage site start‑up activities, including regulatory submissions to EC/IRB and authorities.
• Train, support and advise investigators and site staff on study procedures and Risk Based Quality Management principles.
• Conduct monitoring visits (onsite and remote), perform source data review, case report form review and source data verification according to the monitoring plan.
• Maintain study supplies, investigator site files and drug accountability, and prepare drug for destruction when required.
• Update the Clinical Trial Management System (CTMS) and other study databases with timely site data.
• Participate in Local Study Team meetings, share recruitment updates and drive site performance.
• Perform regular site quality risk assessments and adjust monitoring intensity as needed.

Required profile

• Experience as a Clinical Research Associate or Senior Clinical Research Associate in clinical trials.
• Strong knowledge of ICH‑GCP, local regulatory requirements and study documentation.
• Ability to train investigators, manage site relationships and resolve study‑related issues.
• Excellent organizational skills and attention to detail.

Required skills

• ICH‑GCP compliance
• Risk Based Quality Management (RbQM)
• Clinical Trial Management System (CTMS) usage
• Regulatory submission processes (EC/IRB, authorities)