Clinical Research Referent (RRC) – Paris – Bordeaux – M/F At ALIMA

PRESENTATION ALIMA

THE ALIMA SPIRIT: ALIMA’s purpose is to save lives and care for the most vulnerable populations, without any identity, religious or political discrimination, 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.

THE VALUES and PRINCIPLES of our action, enshrined in our CHARTER:

1. The patient first
2. Revolutionizing humanitarian medicine
3. Responsibility and freedom
4. Improve the quality of our actions
5. Trust
6. Collective intelligence
7. Environmental responsibility

ALIMA promotes and defends the principles of fundamental human rights. ALIMA has a zero-tolerance approach towards people guilty of acts of gender-based and sexual violence as well as towards inaction in the face of alleged or proven acts of violence. Protecting those benefiting from and impacted by our intervention is our top priority in everything we do. Anyone collaborating with ALIMA undertakes to:

• Respect the charter, the code of conduct, institutional policies including the protection policy against abuse of power and sexist and sexual violence, the corruption and fraud prevention policy;
• Report any violation of policies, framework documents and procedures to a superior, referent.

CARE – INNOVATE – TOGETHER: Since its creation in 2009, ALIMA has reached more than 18 million beneficiaries in 15 countries, mainly in Africa. In 2024, we developed 59 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 health structures (including hospitals and health centers). Our action results from constant adaptation to realities on the ground and advances in medicine. In 2024, ALIMA reached 5.9 million beneficiaries. We work in partnership, particularly with local NGOs, whenever possible to ensure that our patients benefit from expertise where it is foundwhether at the level of their country or the rest of the world. Furthermore, to improve the humanitarian response, we carry out operational and clinical research projects, particularly in the field of the fight against malnutrition and viral hemorrhagic fevers.

THE ALIMA TEAM: more than 2000 people currently work for ALIMA. The field teams, as close as possible to patients, receive their support from coordination teams generally based in the capital of the countries of intervention. These receive support from the 4 desk teams and the emergency and opening department 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, the research organizations PACCI, INSERM, INRB, the Universities of Bordeaux or Copenhagen, the NGO Solidarités International and many others.

OUR PROJECT THEMES: Malnutrition, Sexual and reproductive health including gender-based violence, Primary and secondary health, surgery, pediatric care, killer diseases such as Malaria, AKI, Diarrhea, Epidemics (hemorrhagic fevers, meningitis, Cholera, Measles, Dengue, Covid-19).

OUR COUNTRIES OF INTERVENTION: Mali, Burkina Faso, Central African Republic, Ethiopia, Haiti, Nigeria, Niger, Chad, Democratic Republic of Congo, Cameroon, Guinea, South Sudan, Senegal, Mauritania and Sudan.

JOB CONTEXT

JOB TITLE: Clinical Research Referent (RRC)

PLACE OF ASSIGNMENT: Paris or Bordeaux, with regular travel to the various implementation sites in sub-Saharan Africa

Functional links:

• She.he reports to the coordinator of the MIE research center.
• She.he collaborates closely with the representatives at the ALIMA headquarters in Dakar (Desks) and the coordinations of the countries and sites concerned.
• She works closely with the promoter, the main investigators and all the project partners.

Research at ALIMA: The Emerging Infectious Diseases (EID) division

ALIMA’s Emerging Infectious Diseases (EID) research center designs and coordinates clinical research projects in Africa on viral hemorrhagic fevers (Lassa fever, Ebola virus disease) and other diseases with epidemic potential. As part of its activities, the center coordinates consortia of research partners, as well as the implementation and monitoring of activities in the field. In close collaboration with the promoter(s), local health authorities, research institutions and communities, we manage the entire life cycle of research projects, from their design to their integration into operational contexts. We are a research center within a medical humanitarian NGO. By implementing research projects in the south,particularly in an epidemic context, our objective is to contribute to improving care in communities, patient care and strengthening capacities for preparation and response to epidemics. As part of our activities, we coordinate different clinical research consortia and manage research projects in a humanitarian context, from their design to their implementation in the field to the results of the study. In particular, we coordinate the EBO-PEP consortium, a clinical trial dedicated to post-exposure prophylaxis against the Bundibugyo Ebola virus disease prevalent in the DRC.As part of our activities, we coordinate different clinical research consortia and manage research projects in a humanitarian context, from their design to their implementation in the field to the results of the study. In particular, we coordinate the EBO-PEP consortium, a clinical trial dedicated to post-exposure prophylaxis against the Bundibugyo Ebola virus disease prevalent in the DRC.As part of our activities, we coordinate different clinical research consortia and manage research projects in a humanitarian context, from their design to their implementation in the field to the results of the study. In particular, we coordinate the EBO-PEP consortium, a clinical trial dedicated to post-exposure prophylaxis against the Bundibugyo Ebola virus disease prevalent in the DRC.

The CEF research center team, based in France, brings together experienced professionals in clinical research and humanitarian action with complementary profiles (doctors, nurses, pharmacists, epidemiologists, laboratory technicians). Each Clinical Research Manager (RRC) coordinates one or more studies in conjunction with all ALIMA operational teams and national and international partners. Due to the epidemic nature in which these studies take place, RRCs must be highly available for field deployments (duration 1 week to 2-3 months), sometimes with very short notice, as well as great autonomy in project management and an ability to evolve in complex humanitarian contexts. The RRCs combine scientific and regulatory coordination.operational management and support for field teams.

PROTECTION OF BENEFICIARIES AND MEMBERS OF THE COMMUNITY

Level 3: The position holder is responsible for the application of HR processes and may be required to carry out field visits. She. He may therefore be in contact with children and/or vulnerable adults. Therefore, criminal record check or presentation of a certificate of good conduct and morals will be necessary. In situations where it is impossible to provide a criminal record or a certificate of good conduct and morals, a sworn declaration will be requested

MISSION AND MAIN ACTIVITIES

In collaboration with the coordinator of the MIE center and the principal investigator, the RRC coordinates the activities of the EBO-PEP project.

1. Lead and coordinate the EBO-PEP consortium

• Ensure good relations between the various consortium partners, the promoter, the donor(s) and the institutions involved in the study.
• Interface with the promoter and coordinate with him the monitoring of the progress of the trial, operational difficulties, decisions to be made and actions to be implemented.
• Organize and monitor the contributions of the various partners, defining with them the responsibilities, deliverables and deadlines of each, and ensuring their monitoring.
• Support the institutions and teams responsible for implementing the trial, by facilitating the resolution of difficulties encountered and ensuring coordination with other project stakeholders.
• Organize and lead consortium meetings and exchanges between the different partners (working groups). Including the scientific committees and other governance bodies of the study.
• Ensure the transmission of information necessary for monitoring activities and decision-making between the various consortium partners.
• Document and archive the consortium’s activities, exchanges and decisions.
• Coordinate the preparation and consolidation of reports intended for partners, the promoter and the lessor.

2.Ensure the implementation and monitoring of the EBO-PEP study

• Plan, coordinate and monitor the implementation of all project activities, in collaboration with the various partners.
• Ensure operational coordination between the ALIMA headquarters teams, the promoter, the monitoring and data processing team, the field teams and other institutional partners.
• Ensure compliance with the schedule, objectives, regulatory requirements, applicable procedures and budget, identify deviations and implement corrective actions.
• Coordinate, in collaboration with principal investigators and the sponsor, relationships with suppliers of trial drugs, including contracting, planning and monitoring of shipments.
• Identify and anticipate operational and medical risks and constraints likely to affect the implementation of the study.
• Participate in the recruitment of field teams for the implementation of activities and provide technical and operational support.
• Coordinate the necessary deployments during the launch, opening of new sites or the evolution of studies in an epidemic context.
• Participate in the definition of operational needs and the preparation of calls for tenders.
• Participate in the development, monitoring and revision of the budget.
• Ensure monitoring of commitments, deliverables and deadlines from different donors.
• Organize and contribute to the preparation of progress reports and reporting.

3. Coordinate study documentation and ensure compliance with ICH E6 (R3) Clinical Trial Best Practices (CPB) at the implementation site

• Collaborate with the sponsor, international and local regulatory authorities for the implementation of the research.
• Organize compliance with legal requirements: ethics committees, drug regulations…
• Collaborate with the trial data monitoring and management team that ensures data quality collection and monitoring for the implementation of activities in accordance with the protocol, applicable procedures and principles of ICH E6 PCBs (R3).
• Organize the implementation of study documents (Source Documents, Case Report Form, database …) in collaboration with the monitoring and data management team.
• Organize initial and continuing training for members of the field research team in collaboration with the monitoring and data management team.
• Contribute to the preparation and execution of audits of inclusion sites.
• Maintain open communication with investigators and sponsors to ensure compliance with PCBs.

4. Contribute to the scientific valorization of the study

• Coordinate the writing of study protocols and trial documents, in collaboration with the monitoring and data processing team and principal investigators, and ensure follow-up.
• Contribute to the scientific valorization of the results obtained (writing of articles, various scientific communications), in support of principal investigators.

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

• Participates in training and awareness sessions,
• Applies standards relating to the prevention of abuse,
• Ensures, where applicable, that team members follow training and awareness sessions and apply abuse prevention rules.
• Helps create and maintain a fulfilling and protective environment.

PROFILE SEARCH

Experiences/Candidate training

• Doctor, nurse, pharmacist or laboratory diplomas.
• Master’s or thesis in public health/epidemiology.
• Field experience, and the implementation of mandatory clinical trials.
• Strong ability to manage complex projects
• Prior experience coordinating clinical trials of at least 2 years.
• Knowledge of good practices related to mandatory clinical research: Regulatory aspects, ethics and vigilance.
• Experience and appetite in data creation and management.
• Fluency in oral and written French and English is essential.

Regular trips to the field are to be expected.

JOB CONDITIONS

Duration of contract: 12-month fixed-term contract

Taking up a position: As soon as possible

Salary: According to ALIMA salary scale