Lead Clinical Research Associate

About the role

PSI, a leading Contract Research Organization, is seeking a Lead Clinical Research Associate to oversee study startup, monitoring, and site management across multiple therapeutic areas. The role serves as the primary liaison between monitors, site teams, and project leadership, ensuring timelines, data integrity, and regulatory compliance are met.

Key responsibilities

• Coordinate investigator feasibility, site identification, and study startup activities.
• Monitor project timelines, patient enrollment, and implement corrective actions.
• Review monitoring visit reports and ensure regional reporting compliance.
• Manage query resolution, safety information flow, and protocol deviation reporting.
• Oversee clinical supplies management with vendors at country and regional levels.
• Lead communication between monitors, Site Management Associates, Regional Project Leads, and Project Managers.
• Plan, conduct, and supervise monitoring visits, site audits, and audit finding resolutions.
• Guide the project team in site contracting, payments, CAPA development, and process deviation management.
• Provide training, mentorship, and presentations for monitors and investigators.

Required profile

• Proven experience in clinical research monitoring and project coordination.
• Demonstrated ability to lead and mentor monitoring teams.
• Strong organizational and communication skills for multi‑stakeholder environments.
• Experience preparing and conducting site audit visits.

Required skills

What we offer

• Opportunity to work with a globally recognized CRO.
• Exposure to a variety of therapeutic indications and complex studies.
• Professional development through training and mentorship responsibilities.