Epicentre recrute 01 Coordinateur d’études Tuberculose
Coordinateur d’études Tuberculose (H/F) 12 mois
• Mbarara, Ouganda
• Temps complet
Description de l’entreprise
Epicentre is an organisation created by Médecins Sans Frontières (MSF) in 1986. We conduct field epidemiology, training, and research activities for MSF interventions. Our activities for populations in precarious situations are led from Uganda, Niger, and France, and through the programs of MSF and others. They mainly concern infectious diseases and undernutrition.
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.
Seven different studies on tuberculosis are planned or have initiated at Epicentre Mbarara. These studies involve different funders and sponsors but are all implemented by Epicentre Mbarara. The first is an international multicenter controlled clinical trial to evaluate different doses of Rifampicin in the reduction of treatment duration for pulmonary tuberculosis in adults. The second is another multicenter project with 4 different studies to be implemented in phases including working with peripheral sites to increase capacity of TB diagnosis, improving early diagnosis of TB in children with severe pneumonia, validation of diagnostic tools and algorithm HIV-infected children and identification of optimized, suitable, and affordable specimen processing and collection methods for childhood TB diagnosis in resource limited countries. The third project compares different models for tuberculosis screening and preventive therapy in child contacts of high burden and limited resource countries and the fourth project under preparation is a therapeutic trial evaluating an intensified treatment for tuberculosis meningitis in two regional reference hospitals (Mbarara and Kabale).
Description du poste
Mission and responsibilities
The Tuberculosis study Coordinator will be responsible for ensuring coordination across studies and with the country principal investigators and project managers in the preparation and implementation of the various TB research projects in coordination with the Director of the research center, and other partners or their designates.
The Tuberculosis Study Coordinator will support the study principal investigators, senior research assistant and junior research assistants in order to:
• Ensure studies are implemented in compliance with the study protocol and in accordance with GCP regulations
• Develop and finish to completion Standard Operating Procedures
• In collaboration with study staff and sponsors, ensure the approval processes from the local and national Regulatory Authorities and Ethics Committee bodies, as applicable, including amendments of protocol and informed consent forms
• Ensure that data is collected, recorded, handled, stored and reported accurately on Case Report Forms
• Ensure the adequate medical care of study participants for any adverse event
• Ensure follow-up of reporting notifiable events to the Sponsor, relevant local ethics and regulatory authorities
• Supervise, together with the research assistant where applicable, the field investigators and advise the study doctors, nurses, field workers in performance of their duties
• Ensure staff are appropriately monitoring study materials including but not limited to drugs, sundries, diagnostic tools
• Generate timely study reports and contribute to writing of monthly site report
• Together with the PI or research assistants, communicate with Sponsor, Sponsor’s investigator and partners when needed ensuring that communication is fluid and any difficulties tracked and resolved appropriately
• 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
• Coordinate with the pharmacist coordinator, lab coordinator and other team members to ensure problems are resolved promptly and anticipated.
• Develop study budget and financial report with the resource manager
• 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 the relevant team members in Paris or Montpellier (IRD), and the Director of the Centre
• Ensure good communication with other investigators and the study team.
• Medical doctor registered to practice in their country of origin with advanced training in clinical research, epidemiology or public health
• Previous experience on clinical trial study implementation or 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
• Demonstrated knowledge of tuberculosis
• Training in Good Clinical Practice
Position based in Mbarara, Uganda
Short term Contract: minimum 12 months starting as soon as possible
MSF/Epicentre expatriate contract