Clinical Research Associate (CRA) – Site Monitoring

About the role

The Clinical Research Associate (CRA) will manage and monitor clinical trial sites in accordance with Fortrea’s SOPs, ICH GCP guidelines, and sponsor requirements. The role ensures subject protection, data integrity, and regulatory compliance throughout the study lifecycle.

Key responsibilities

• Conduct pre‑study, initiation, routine, and close‑out monitoring visits at assigned sites.
• Verify informed consent, eligibility, and protocol adherence for each participant.
• Perform source document review, 100% source data verification, query generation and resolution using Fortrea or client eCRF systems.
• Maintain up‑to‑date regulatory files and electronic trial master file (eTMF) documentation.
• Oversee investigational product inventory, accountability, and secure storage.
• Prepare and submit accurate trip reports and ensure audit readiness at site level.
• Act as Lead CRA when assigned, coordinating monitoring activities across multiple sites.
• Support project administration, investigator recruitment, and collection of site documentation.

Required profile

• Strong knowledge of ICH GCP, clinical trial SOPs, and regulatory requirements.
• Ability to travel frequently, including air travel, to monitor sites onsite.
• Excellent attention to detail for data verification and document control.
• Capacity to work independently and manage multiple monitoring tasks efficiently.

Required skills

• eCRF review and data management.
• Source data verification (SDV).
• Query generation and resolution.
• Regulatory document management (eTMF).

What we offer

• Opportunity to work on diverse therapeutic areas within a global CRO environment.
• Professional development through exposure to complex clinical studies.