Lead Clinical Research Associate

About the role

PSI, a leading Contract Research Organization, is seeking a Lead Clinical Research Associate to provide leadership and oversight for clinical trial activities at a country or regional level. The role focuses on remote monitoring, mentorship, and ensuring high‑quality execution, compliance, and timely delivery of studies.

Key responsibilities

• Monitor project timelines, patient enrollment, data cleaning and compliance, implementing corrective and preventive actions.
• Review monitoring visit reports and ensure reporting compliance across the region.
• Serve as the primary communication link between Monitors, Site Management Associates, Regional Project Leads and Project Managers.
• Lead country‑level project calls, provide status updates and prepare training materials.
• Supervise source data verification, data query resolution and study risk management at site level.
• Oversee investigational product handling, accountability, reconciliation and return.
• Review essential study documents and supervise Investigator Site File/TMF reconciliation.
• Collaborate on site feasibility, study startup and safety information flow.
• Coordinate clinical supplies management with vendors and maintain tracking systems.
• Plan and conduct supervised monitoring visits, manage site contracting and payments.
• Prepare sites for audits, coordinate audit findings resolution and oversee CAPA development.

Required profile

• Proven experience in clinical research monitoring with a strong understanding of GCP and regulatory compliance.
• Demonstrated leadership and mentorship abilities within a study team.
• Excellent coordination skills across cross‑functional teams and regions.
• Ability to work with minimal travel, providing remote oversight and guidance.
• Strong analytical skills for data integrity assessment and risk management.

Required skills