Senior Clinical Research Associate (CRA II)

About the role

Fortrea is seeking an experienced Clinical Research Associate (CRA II / Senior CRA) to manage site monitoring activities for clinical studies in compliance with ICH GCP, SOPs and sponsor requirements. The role involves extensive travel to study sites and close collaboration with study teams to ensure data integrity, patient safety and regulatory compliance.

Key responsibilities

• Plan and execute site monitoring visits (pre‑study, initiation, routine, close‑out) according to project plans and SOPs.
• Verify informed consent, eligibility, IP accountability and source documents; generate and resolve queries.
• Maintain regulatory documentation, eTMF and study‑specific trial management tools.
• Track IP shipments, monitor serious adverse events and ensure audit readiness.
• Prepare trip reports, monitoring plans, site initiation slides and present training to site staff.

Required profile

• University degree or allied health certification (e.g., nursing) or equivalent experience.
• Minimum 2 years of clinical monitoring experience, preferably with phase I studies.
• Strong knowledge of ICH GCP, local regulations and monitoring procedures.
• Ability to work independently, travel up to 60 % of the time and manage expenses efficiently.

Required skills

• ICH GCP compliance
• eCRF review and source data verification
• eTMF and clinical trial management systems (CTMS)
• Microsoft Office and Windows PC proficiency