Clinical Research Referent – ​​Paris/Bordeaux – M/F At ALIMA

ALIMA PRESENTATION

THE ALIMA SPIRIT: ALIMA’s purpose is to save lives and care for the most vulnerable populations, without any discrimination based on identity, religion or politics, through actions based on proximity, innovation and alliance of organizations and individuals. We act with humanism, impartiality and respect for universal medical ethics . To access patients, we are committed to intervening in a neutral and independent manner.

CARE – INNOVATE – TOGETHER: Since its creation in 2009, ALIMA has treated more than 10 million patients, and today deploys its operations in 12 African countries. In 2022, we have developed more than 60 humanitarian medical response projects to meet the needs of populations affected by conflicts, epidemics and extreme poverty. All of these projects support national health authorities through nearly 511 health structures (including 47 hospitals and 464 health centers). We work in partnership, particularly with local NGOs, whenever possible in order to improve access and the transfer of skills which ensures the sustainability of our actions for our patients. Furthermore, to improve the humanitarian response, we are carrying out operational and clinical research projects, particularly to combat malnutrition and viral hemorrhagic fevers.

THE ALIMA TEAM: More than 2,000 people currently work for ALIMA. The field teams, closest to the patients, receive their support from the coordination teams generally based in the capital of the countries of intervention. They receive support from the 4 desk teams and the emergency and openings service team based at the operational headquarters in Dakar, Senegal. The Paris and New York teams are actively working on fundraising and representing ALIMA. The rest of the ALIMA Galaxy includes individuals and partner teams who work on behalf of other organizations such as the medical NGOs BEFEN, ALERTE Santé, SOS Médecins, KEOOGO, AMCP-SP, DEMTOU-Humanitaire, PAC research organizations -CI, Inserm, the Universities of Bordeaux or Copenhagen and many others.

OUR COUNTRIES OF INTERVENTION: Burkina Faso, Cameroon, Guinea, Mali, Mauritania, Niger, Nigeria, Central African Republic, Democratic Republic of Congo, Sudan, Chad, Ukraine.

OUR PROJECT THEMES: Malnutrition, Maternal Health, Primary Health, Pediatrics, Malaria, Epidemics (Ebola, Cholera, Measles, Coronavirus, Lassa Fever), Research, Hospitalization, Emergencies, Gender-Based Violence, vaccinations, mental health, etc.

CONTEXT

Research at ALIMA: CORAL, Emerging Infectious Diseases (EIM) division

The CORAL (Clinical and Operational Research Alliance) platform was created in 2016 by ALIMA, INSERM and PAC-CI following their collaboration in the response to the Ebola Virus Disease epidemic in Guinea. This platform aims to combine research and humanitarian action in order to improve the quality of care delivered to populations in crisis situations and thus reduce mortality. The CORAL platform carries out research projects on emerging infectious diseases and maternal and child health, particularly acute malnutrition. The MIE center conducts research projects in Africa on viral hemorrhagic fevers (Lassa fever and Ebola Virus Disease) as well as on COVID-19.

Lassa fever (LF) is a viral hemorrhagic fever that occurs in West Africa, with a hospital mortality of 12%. The disease particularly affects Nigeria. Ribavirin is the only treatment available and there is an urgent need for new drugs. The INTEGRATE consortium, bringing together 15 partners from 10 countries in West Africa, Europe and North America, was created to implement effective countermeasures against the disease. The INTEGRATE project is a platform, multicenter, phase II-III clinical trial whose main objective is to compare the effectiveness of several investigational medical products (IMP) to the standard of care drug (Ribavirin) in hospitalized patients suffering from of confirmed FL. This unique and innovative trial is being implemented at two sites in Nigeria.

PROTECTION OF BENEFICIARIES AND COMMUNITY MEMBERS

Level 3 : As part of their duties, the position holder will be required to visit programs and be in contact with children and/or vulnerable adults. Therefore, criminal record check will be necessary.

FUNCTIONAL AND HIERARCHICAL LINKS

• You report to the coordinator of the emerging diseases research center,
• You are responsible for field research project managers,
• You work closely with ALIMA headquarters and the coordination of the country concerned.

POSITION LOCATION

Mission location: Bordeaux or Paris.

MISSION AND MAIN ACTIVITIES

On delegation from the coordinator of the emerging disease center, the research project manager coordinates the activities of ALIMA research projects in the mission countries. He/she works in close collaboration with the referents located at the ALIMA headquarters in Dakar (medical, financial, HR, logistics referent) and the Program Manager; as well as with the ALIMA coordination in Abuja and the ALIMA team on the ground.

1. General coordination of the clinical trial

• Coordination of the consortium: Ensures the link with the coordinator and the project partners,
• Preparation and animation of consortium meetings (Board meetings, Steering committee, Copils, etc.),
• General monitoring of the project: monitoring the progress of expected deliverables, validates the planning of activities and the project timeline,
• Administrative and budgetary monitoring in collaboration with the administrative and financial project manager of the project (budgetary reviews and monitoring of financial reporting, organization of travel for the various team members, monitoring of the hiring of personnel necessary for the project)
• Monitoring of regulatory activities linked to the research project: proofreading and monitoring of contracts,
• CORAL / ALIMA representation in regional and international conferences and seminars

2. Responsible for monitoring the project with the lessor and sponsor

• Coordinates communication with the lessor,
• Participates in the development of new calls for tenders,
• Contractual monitoring (drafting of reports) with the lessor and sponsor.

3. Organization of field activities

In collaboration with those responsible for the operational and engineering implementation of the project:

• Coordination of the organization of the test work packages,
• Provides technical support to research teams in the field,
• Logistics and engineering monitoring (BPC) for the implementation and monitoring of the trial, collaboration with the database management and monitoring team,
• Ensures weekly monitoring of projects and participates in team meetings,
• Participates in training and awareness sessions,
• Acts as project manager in the field at the request of the center coordinator.

4. Responsible for writing scientific documents

• Responsible for writing study protocols which will be validated by the coordination,
• Responsible for amendments to study protocols including him. She ensures follow-up,
• Sharing and communication after submission to the ethics committee,

5. Implementation of preventive measures against abuse of power, gender-based and sexual violence:

• Applies standards relating to the prevention of abuse,
• Ensures, where applicable, that the members of his team follow training and awareness sessions and apply the rules for preventing abuse,
• Contributes to creating and maintaining a fulfilling and protective environment.

EXPERIENCES ET COMPETENCES

Formation

You hold a higher degree as a doctor, nurse or pharmacist (Master’s degree or thesis in public health/epidemiology). You have at least 1 year of prior experience in clinical research (clinical trials), you have good experience in research project management, good knowledge of good clinical practices and emerging infectious diseases. You have an appetite for creating and managing data. You have a good command of the Office pack, other collection software, data analysis. You also have good statistical analysis skills.

LANGUAGES

Excellent written and oral expression in French and English

CONDITIONS

Type of contract: Fixed-term contract under French law

Contract duration: 7 months renewable

Start date: June 2024

Salary: Level 8 of the Paris Headquarters Grid

• Five weeks of paid leave per year and recovery day system for business travel
• Supplementary health coverage for the employee and their dependents.
• Restaurant voucher worth €9.25/day of which 60% (€5.55) paid by ALIMA and €3.70 (40%) by the employee
• 1.95 days of RTT per month.
• 201.6 actual working days per year
• 50% coverage for public transport in the Paris region