Epicentre is a non-profit organization created by Médecins Sans Frontières (MSF) and dedicated to research, field epidemiology and training in line with both MSF programmes and Epicentre’s Research Centres in Uganda and Niger. Epicentre is a World Health Organization Collaborating Centre.

The Ugandan Research Centre conducts research activities on public health issues relevant to Africa, according to GCPs (Good Clinical Practices) quality standards, in close collaboration with MSF, Mbarara University of Science & Technologies, and other stakeholders in health sector. Current projects, include clinical and vaccinal trials, focus on TB, HIV, central nervous system infections, and yellow fever.

Job purpose

The Lead Study Monitor performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and Epicentre SOPs.

Main activities (not exhaustive)

• Define the monitoring procedures, templates and documents related to the studies and develop SOPs and MOPs
• Be responsible for managing the team study monitors and supervising all monitoring activities (reports, follow-up letters, monitoring visits log, product accountability…)
• Support the study team in logistics, site activation documents and site training requirements
• Activate clinical sites according to agreed timelines and quality standards
• Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures and all applicable laws
• Support audit and manage required documentations, and ensure the conformity of data with international quality assurance audits
• Develop collaborative relationships with investigational sites
• Collaborate and work closely with the data-manager and statistician of the studies
• Support the laboratory department to monitor the timely sampling and knowledge of transportation for samples and work closely with the Laboratory Quality Control Manager

·       Training in public health or epidemiology

·       At least 10 years of experience in monitoring of research projects

·       Good understanding of good clinical and participatory practice

·       Strong experience in clinical research

·       Demonstrate strong analytical, problem solving skills

·       Strong written and verbal communication skills

·       Detail oriented, good organizational traits

·       Self-motivated, with strong leadership abilities

·       Multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines

·       Good computer skills and adapt easily to technology to maximize efficiency

Position based in Mbarara – Uganda.

Local/Expatriate MSF-Epicentre contract of 12 months starting as soon as possible.