Clinical Research Associate II (CRA II)

About the role

The Clinical Research Associate II (CRA II) will manage site activities for clinical studies, ensuring compliance with Fortrea’s SOPs, ICH GCP guidelines, and sponsor requirements. This role involves on‑site monitoring, data verification, and safeguarding subject protection throughout the trial lifecycle.

Key responsibilities

• Conduct pre‑study, site initiation, routine, and close‑out visits according to SOPs and regulatory standards.
• Verify informed consent procedures, eligibility criteria, and protocol adherence at each site.
• Perform source document review, 100% source data verification, query generation and resolution using Fortrea or client eCRF systems.
• Maintain accurate investigational product inventory and ensure secure storage of study materials.
• Confirm completeness and currency of site regulatory documents and eTMF records.
• Prepare and submit timely trip reports and ensure audit readiness at the site level.
• Act as Lead CRA when assigned, coordinating monitoring activities and resources efficiently.

Required profile

• Experience conducting site monitoring for clinical trials in accordance with ICH GCP and SOPs.
• Strong understanding of regulatory requirements, informed consent processes, and protocol compliance.
• Ability to travel frequently, including air travel, and work on‑site at multiple locations.
• Attention to detail for data integrity, source verification, and query management.

Required skills

• Proficiency with electronic case report form (eCRF) systems and clinical data management platforms.
• Knowledge of electronic trial master file (eTMF) processes.