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 across a country or region. The role focuses on ensuring high‑quality execution, regulatory compliance, and timely delivery while operating primarily through remote monitoring and coordination.

Key responsibilities

• Monitor project timelines, patient enrollment, data cleaning and implement corrective actions.
• Review monitoring visit reports and ensure compliance across the region.
• Serve as the main communication hub between monitors, site management, regional 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, clinical supplies management and reconciliation of study documents.
• Coordinate safety information flow, protocol deviation reporting and central monitoring observations.
• Support site feasibility, startup, contracting, payments and audit preparation.
• Guide the project team in CAPA development and implementation.

Required profile

• Extensive experience in clinical monitoring and trial oversight.
• Proven leadership and mentorship abilities within a study team.
• Strong understanding of regulatory compliance and data integrity standards.
• Excellent communication skills for cross‑functional coordination.

Required skills