Description of the organization

Created by Médecins Sans Frontières (MSF) in 1986, Epicenter carries out field epidemiology, training and medical research activities in support of MSF’s humanitarian objectives. We have 3 research centers in France, Niger and Uganda and outsourced epidemiologists. Our areas of expertise cover infectious diseases (malaria, TB, HIV, cholera, Ebola…), neglected diseases (leishmaniasis, trypanosomiasis…) and chronic diseases booming in African countries such as diabetes and cancer.

General mission

As part of clinical trials conducted by Epicenter/MSF on Ebola caused by the Bundibugyo virus (BDBV) in the Democratic Republic of Congo (DRC) and potentially in other countries, l’Clinical Research Associate (ARC) ensures the quality and regulatory compliance of studies in accordance with the applicable ICH Good Clinical Practice (ICH-GCP) guidelines, provides clinical monitoring, supervises the management of investigational products in collaboration with a responsible pharmacist and contributes to the quality management system, in operational support to project teams.

1. Coordination of clinical monitoring activities

• Define, implement and monitor the monitoring plan using a risk-based approach.
• Develop study-related documentation for submission of research protocols to local and national ethics committees (ERBs) and, if necessary, regulatory authorities.
• Plan and organize monitoring activities in accordance with the budget, schedule and study requirements.
• Depending on the organization chosen:
• Directly carry out monitoring activities as an ARC, including on-site visits and drafting of associated reports.
• Select, train, support and supervise external monitoring providers for studies.
• Review and approve monitoring reports.
• Identify, document and escalate monitoring findings with study teams.
• Monitor the definition and implementation of corrective and preventive actions (CAPA).
• Facilitate and organize all study-related committees, including meetings and documentation (DSMB, Scientific Committee, as well as one-off teleconferences with various partners).

2. Support for study quality management

• Contribute to the study risk management process (identification, evaluation, mitigation, monitoring), in accordance with ICH-GCP principles and the Epicenter quality system.
• Ensure the implementation and maintenance of documentation essential to the study quality management system (ISF, TMF, source documents, procedures and standardized forms).
• Provide support for training teams in study procedures and standard operating procedures (SOPs), both at central and local level.

3. Support for safety review and pharmacovigilance activities

Main activities, but not limited to, in collaboration with the Pharmacovigilance Officer:

• Check consistency and information contained in serious adverse event (SAE) reports.
• Ensure that EIG reports are transmitted within the deadlines provided for by the protocol.

4. Pharmaceutical management of investigative products

• Ensure monitoring of regulatory registration procedures for investigative products when required.
• Check the proper management, traceability and accounting of investigation products.
• Verify compliance of storage, distribution, use, return, reconciliation, inventory and destruction practices of investigative products, in accordance with current procedures and regulations. Ensure that pharmacists gather, maintain and update all documentation regarding investigational products used in clinical trials.
• Check compliance with the cold chain throughout the life cycle of investigation products, including temperature monitoring, management of thermal excursions, associated documentation and compliance with quality procedures in force, particularly in areas with high logistical constraints in eastern DRC.

5. Support for project coordination

• Support the Project Manager(s) in study coordination activities:
• Business planning;
• Monitoring of objectives, deliverables and milestones;
• Coordination of meetings and steering committees;
• Documentary management of studies.
• Provide support to IPs (Principal Investigators) and study teams for the daily management of trials.
• Contribute to scientific monitoring linked to Ebola trials.

Functional relationships

The ARC works closely with:

• The Project Managers in the DRC;
• The operational and logistics teams of MSF and Epicenter;
• The Principal Investigators;
• Epicenter’s Pharmacy, Quality, Monitoring and Pharmacovigilance teams;
• Institutional and regulatory partners.

Diploma

• Master’s degree in public health, biology or equivalent scientific discipline, supplemented by Clinical Research Attaché(e) training (ARC).
• A degree in pharmacy or medicine would be a plus.

Experience

• Proven experience in monitoring phase 2/3 clinical trials, including autonomous conduct of monitoring visits and monitoring of corrective and preventive action plans (CAPA).
• At least 2 years of prior professional experience in resource-limited countries, in humanitarian contexts or in complex operational environments.
• Experience with MSF or other NGOs is a plus.

Knowledge and skills

• Excellent analytical, synthesis, writing and communication skills.
• Ability to adapt to complex or atypical situations as well as varied cultural contexts.
• Ability to integrate effectively and collaborate within multidisciplinary and multicultural teams.
• Organizational skills and ability to manage priorities in a demanding environment.
• Strong taste for collaborative work in international and multicultural environments.
• Rigor, sense of responsibility and ability to supervise, support and supervise a team.
• Available ASAP.

Languages

• French and English C1 level minimum.
• Additional information

  Terms

  Position based in Paris with numerous international trips, mainly in the East of the DRC. Remuneration: 55,286 Euros annually over 13 months.

  Duration: 12-month renewable fixed-term contract

  Advantages:

• 25 days of paid leave + 22 additional days of leave
• Restaurant vouchers (12 €/day, 60% covered by Epicenter)
• Mutual insurance covered 100%
• Reimbursement of 50% of the public transport ticket in Ile de France.
• Due to administrative constraints linked to the duration of the contract, candidates must already have a work authorization in France (citizen of the European Union) or a residence permit allowing them to work on French soil.

  Why join us?

• You will work with a multicultural team in the field of epidemiological research
• You will evolve in the humanitarian environment
• Your contributions and ideas will be valued and highly appreciated
• You will participate in the life of the association and your missions will evolve as you become involved.

How to apply

Please submit your application via this link (CV and cover letter) no later than October 4, 2026 .

We value diversity and seek to have an inclusive and accessible work environment. We encourage all individuals who meet the required qualifications to apply, regardless of their ethnic, national or cultural background, age, gender, sexual orientation, religious beliefs, disability or other aspects of their identity.

Epicenter is committed to the protection of the personal data of its members, employees and people wishing to join the association. The data collected during this application will be strictly transmitted, for fair and quality treatment, to people involved in the recruitment process, regardless of where the Epicenter structure to which they belong is located.

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