Lead Clinical Research Associate

About the role

As a Lead Clinical Research Associate at PSI, you will provide leadership and oversight for clinical monitoring activities across a country or region. You will guide a team of monitors, ensure high‑quality execution of trials, and act as the main communication hub between cross‑functional stakeholders while operating in a low‑travel, remote‑focused model.

Key responsibilities

• Monitor project timelines, patient enrollment, data cleaning and compliance, implementing corrective and preventive actions.
• Review monitoring visit reports and ensure reporting compliance of monitors in the region.
• Lead country‑level project calls, provide status updates to Regional Lead and Project Manager.
• Prepare and deliver project‑specific training materials under supervision.
• Supervise source data verification, manage data queries and study risks at site level.
• Oversee investigational product handling, accountability, reconciliation and return.
• Review essential study documents and supervise Investigator Site File / Trial Master File 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 support CAPA development.

Required profile

• Proven experience in clinical monitoring with a focus on leadership or supervisory responsibilities.
• Strong understanding of GCP, regulatory compliance and clinical trial processes.
• Excellent communication skills to act as liaison between monitors, sites and project teams.
• Ability to mentor and train monitoring staff and drive consistent monitoring practices.
• Detail‑oriented with a focus on data integrity and risk management.

Required skills