Consultant, Clinical Research Associate (Diagnostics)

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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. 

PATH seeks a Consultant Clinical Research Associate with expertise in in vitro diagnostic (IVD) clinical validation studies.  The consultant will provide operational and technical support to the planning, monitoring, execution, analysis, and dissemination of IVD validation studies conducted in diverse global settings, including low- and middle-income countries (LMICs). Studies may include evaluations of rapid diagnostic tests, molecular assays, digital tools, and other emerging diagnostic technologies for priority epidemic and pandemic-prone pathogens, including the Bundibugyo virus.

The consultant will work closely with study investigators, laboratory partners, implementing organizations, regulatory experts, and country stakeholders to ensure studies are conducted in accordance with Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), applicable regulatory requirements, and organizational standards.

Key responsibilities:

• Support study design, planning, and implementation of IVD clinical performance validation studies.

• Contribute to the development of study implementation plans, timelines, monitoring plans, and risk mitigation strategies. Assist with budget monitoring and resource planning for study activities.

• Assist in preparation and review of study documents, including protocols, informed consent forms, case report forms, laboratory manuals, monitoring plans, and standard operating procedures as applicable.

• Support ethics and regulatory submissions, amendments, and approvals.

• Participate in site feasibility assessments, site selection, and study start-up activities.

• Assist with development of training materials and facilitate investigator meetings.

• Conduct routine study monitoring activities to ensure compliance with approved protocols, GCP, GCLP, sponsor and donor requirements, and applicable regulations.

• Monitor enrollment, specimen collection, testing procedures, data quality, and study progress. Maintain accurate study documentation and tracking systems.

• Review source documentation, case report forms, and study records for completeness, accuracy, and compliance.

• Identify protocol deviations, quality issues, and operational risks and support corrective and preventive action plans.

• Support study teams with issue resolution and implementation of quality improvement measures.

• Provide technical guidance to study sites on study conduct, documentation, and reporting requirements.

• Support study data review, query resolution, and data quality assurance activities.

• Contribute to monitoring and evaluation of study metrics and performance indicators.

• Assist in interpretation and communication of study findings. Support preparation of study reports, donor deliverables, and technical summaries.

• Contribute to scientific publications, conference presentations, technical briefs, and policy-focused dissemination materials.

• Support engagement with research stakeholders, including ministries of health, public health institutions, regulatory authorities, donors, and implementation partners.

Required qualifications:

• Advanced degree in clinical research, public health, epidemiology, microbiology, laboratory medicine, biomedical sciences, or related discipline. A bachelor's degree with significant relevant experience may be considered.

• Minimum 5 years of experience supporting clinical research studies involving investigational products (preferably IVDs).

• Professional working proficiency in both French and English is required.

• Demonstrated experience monitoring clinical studies in accordance with GCP and applicable quality standards.

• Knowledge of clinical research operations, study monitoring, quality management systems, and regulatory requirements.

• Experience with electronic data capture systems and clinical trial management systems.

• Strong project management and organizational skills.

• Excellent written and verbal communication skills.

• Ability and willingness to travel internationally, as required.

Preferred qualifications:

• Experience working in outbreak response, global health, infectious diseases, public health surveillance, or pandemic preparedness programs.

• Experience working with infectious disease diagnostics, including molecular, antigen, serology, or point-of-care testing platforms.

• Experience supporting studies in Africa, Southeast Asia, Latin America, or other low- and middle-income geographies. Prior experience in the Democratic Republic of the Congo a plus.

• Experience with diagnostic studies, especially for viral hemorrhagic fevers, antimicrobial resistance, emerging infectious diseases, respiratory pathogens, or other epidemic-prone pathogens.

• Familiarity with diagnostic quality and regulatory frameworks.

• Certification in clinical research (e.g., ACRP, SoCRA) preferred.

• Experience supporting manuscript development and peer-reviewed publication processes.

Location: This position is remote, but preference will be given to qualified candidates based in the Democratic Republic of the Congo, other African countries, or Europe.