Consultant – Clinical Research Associate (Diagnostics)

About the role

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

Key responsibilities

• Support study design, planning, and implementation of IVD clinical performance validation studies.
• Develop study implementation plans, timelines, monitoring plans, and risk mitigation strategies.
• Assist with budget monitoring, resource planning, and preparation of study documents such as protocols and SOPs.
• Facilitate ethics and regulatory submissions, site feasibility assessments, and study start‑up activities.
• Conduct routine monitoring to ensure compliance with GCP, GCLP, and regulatory requirements.
• Review source documentation, identify deviations, and support corrective actions.
• Provide technical guidance to study sites and support data quality assurance activities.

Required profile

• Demonstrated expertise in IVD clinical validation studies.
• Familiarity with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) standards.
• Experience working with global partners, including laboratories and regulatory bodies.
• Ability to manage study documentation, monitoring, and quality assurance processes.

Required skills

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