Consultant, Clinical Research Associate (Diagnostics)
Core
Consultant Clinical Research Associate providing operational and technical support for in vitro diagnostic (IVD) clinical validation studies in diverse global settings, including low- and middle-income countries.
Role type
Consultant Clinical Research Associate (Diagnostics)
Builds
IVD validation studies for rapid diagnostic tests, molecular assays, and digital tools targeting epidemic and pandemic-prone pathogens.
Domain
Global health, infectious diseases, diagnostics, public health surveillance
Deliverable
client delivery
Required skills
IVD clinical validation study support, GCP/GCLP compliance, study monitoring, protocol development, site feasibility assessment, data quality assurance, regulatory submissions, stakeholder engagement, project management, electronic data capture systems
Preferred skills
Outbreak response experience, infectious disease diagnostics expertise, experience in Africa/Southeast Asia/Latin America, viral hemorrhagic fever studies, diagnostic quality frameworks, clinical research certification, manuscript development
Technologies
Electronic data capture systems, clinical trial management systems
Responsibilities
Support study design, planning, and implementation of IVD clinical performance validation studies; Conduct routine study monitoring to ensure compliance with protocols and regulations; Review source documentation and case report forms for accuracy and completeness; Support ethics and regulatory submissions and approvals; Assist in interpretation and communication of study findings and support preparation of reports and publications; Provide technical guidance to study sites on conduct and reporting requirements.
Seniority
Senior, hands-on IC