Epicentre is an organization created by Médecins Sans Frontières (MSF) in 1986. We conduct field epidemiology, training and research activities for MSF interventions. Our activities with populations in precarious situations are led from Uganda, Niger and France, and on MSF and other programs. They mainly concern infectious diseases and undernutrition.

Context

In 1995, Epicentre created a permanent research center in Uganda to support MSF projects in the region. The primary role of Epicentre in Mbarara is to conduct clinical research following Good Clinical Practice (GCP) requirements on critical public health burdens in Uganda and Africa. A full-time experienced research team is based at the Epicentre Mbarara Research Center.

The Mbarara research center is located in Mbarara Municipality, 300 km South-West to Kampala. The main health facility is Mbarara National Referral Hospital which is also a teaching hospital for the MUST. This is the referral hospital for the Western region of Uganda with a capacity of 240 beds. The research center is structured into several departments: administration, logistics, laboratory, data management.

Three different clinical trials on vaccines are planned or have initiated at Epicentre Mbarara. The first, a sib-study in children on fractional yellow fever vaccine is in collaboration with KEMRI. The second concerns a dose-finding study on yellow fever vaccine aiming to identify the optimal minimal dose, also in collaboration with KEMRI and funded by EDCTP. The third trial is an immunogenicity study of a novel Ebola vaccine among healthcare staff in collaboration with UVRI and funded by CEPI.

Mission and responsibilities

The Vaccine Trial Coordinator is the head of the vaccine clinical trials. He/she works with ate team of clinical researchers, clinicians, nurses, social workers, pharmacist and monitors. He/she will assume responsibility for the proper conduct of the vaccine trials in coordination with the Director of the research center, and Epicentre’s Director of Research or their designate.

Main activities

Coordination and supervision of vaccine trials, together with the research assistant:

·       Be the focal point for headquarters for vaccine clinical trials conducted at Epicentre Mbarara;

·       Monitor the progress of the trials and ensure studies are implemented in compliance with the study protocol and in accordance with GCP regulations;

·       Support research assistants in the development and adaptation of Standard Operating Procedures;

·       Ensure appropriate care of participants and follow-up serious adverse events until resolution;

·       Liaise with research assistants and pharmacist to prepare orders and monitor stock;

·       Provide technical supervision to all members of the medical team and ensure the quality of the health care provided within the research studies;

·       Organize and participate in trainings according to needs.

Communication and reporting:

·       Act as focal point with principal investigators and sponsors, in coordination with research assistants and relevant team members in Paris;

·       In collaboration with principal investigators and sponsors, ensure the approval processes from the local and National Regulatory Authority and Ethics Committee bodies, as applicable, including amendments of protocol and informed consent forms;

·       In liaison with research assistants, ensure follow-up of reporting notifiable events to the Sponsor, relevant local ethics and regulatory authorities;

·       Participate in the development of study reports (ethics committees, regulatory authorities and sponsors);

·       Consolidate monthly site reports;

·       Communicate regularly with Sponsors, principal investigators and partners ensuring that communication is fluid and any difficulties tracked and resolved appropriately;

·       Participate in relevant external study meetings and act as a representative of Epicentre.

Coordination of resources:

·       Coordinate and ensure that studies are on time and on budget in collaboration with the Resource Manager in Mbarara as well as the financial team in Paris;

·       Ensure that the vaccine clinical trials are adequately staffed for the medical part and that medical staff are adequately recruited in terms of skills and qualifications;

·       Together with relevant team members in Paris, resources coordinator, and logistics manager, organize the administrative and logistics support;

·       Coordinate with the pharmacist coordinator, lab coordinator and other team members to ensure problems are resolved promptly and anticipated.

Other activities

·       Participate regularly in meetings and other activities of the medical department and the research centre as a whole when required;

·       Take up any other responsibilities delegated by relevant team members in Paris, and the Director of the Centre;

·       Ensure good communication with other investigators and the study team.

Candidate requirements

·       Medical doctor with advanced training in clinical research, epidemiology or public health

·       Previous experience on clinical trial study implementation and coordination

·       Knowledge of ICH guidelines, GCP, and the clinical trial study process

·       Ability to work effectively in teams as well as independently

·       Strong verbal and written communication skills

·       Training in Good Clinical Practice

Conditions

Position based in Mbarara, Uganda

Short term Contract:  minimum 12 months starting ASAP

MSF/Epicentre expatriate contract