Clinical Research Associate II

About the role

The Clinical Research Associate II will support CTI in monitoring phase I‑IV clinical trials and Real World Evidence studies across the United Arab Emirates. The role involves site management, regulatory compliance, and ensuring high‑quality data collection while adhering to ICH GCP and local regulations.

Key responsibilities

• Conduct site visits (pre‑study, initiation, interim, and close‑out) and deliver timely monitoring reports.
• Assist with study start‑up activities, including feasibility assessments, pre‑study tasks, and site selection.
• Collect, review, and track essential regulatory documents and investigational product accountability.
• Perform remote monitoring and source data verification according to the monitoring plan.
• Support the development and customization of CRFs, patient information sheets, and informed consent documents.
• Provide regular updates to sponsors/clients and assist with contract negotiations and site payments.

Required profile

• Experience in clinical trial monitoring (phase I‑IV) and familiarity with Real World Evidence studies.
• Strong knowledge of ICH GCP, regulatory guidelines, and SOPs.
• Excellent organizational and communication skills for interaction with investigators and project teams.
• Ability to travel to study sites as needed.

Required skills

• ICH GCP compliance
• Remote monitoring techniques
• CRF management and source data verification