Consultant Clinical Research Associate – Diagnostics

About the role

PATH is seeking a Consultant Clinical Research Associate with expertise in in‑vitro diagnostic (IVD) clinical validation. The consultant will support the planning, execution, and analysis of IVD studies across diverse global settings, including low‑ and middle‑income countries.

Key responsibilities

• Assist in designing and implementing IVD clinical performance validation studies, including timelines, monitoring plans, and risk mitigation.
• Prepare and review study documents such as protocols, informed consent forms, case report forms, and SOPs.
• Support ethics and regulatory submissions, amendments, and approvals.
• Conduct site feasibility assessments, selection, and start‑up activities.
• Perform routine monitoring to ensure compliance with GCP, GCLP, and sponsor requirements.
• Track enrollment, specimen collection, testing procedures, and data quality.
• Identify protocol deviations and quality issues, and support corrective actions.
• Provide technical guidance to study sites and assist with data review and query resolution.

Required profile

• Experience conducting IVD clinical validation studies in global or LMIC contexts.
• Familiarity with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards.
• Strong understanding of regulatory requirements for diagnostic studies.
• Ability to work collaboratively with investigators, laboratories, and implementing partners.

Required skills

• In‑vitro diagnostic (IVD) clinical validation
• Good Clinical Practice (GCP)
• Good Clinical Laboratory Practice (GCLP)