Clinical Research Associate (CRA) At Epicentre

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Organization description

Founded by Doctors Without Borders (MSF) in 1986, Epicentre conducts field epidemiology, training, and medical research in support of MSF’s humanitarian objectives. We have three research centers in France, Niger, and Uganda, and deploy epidemiologists. Our areas of expertise cover infectious diseases (malaria, TB, HIV, cholera, Ebola, etc.), neglected diseases (leishmaniasis, trypanosomiasis, etc.), and chronic diseases that are rapidly increasing in African countries, such as diabetes and cancer.

General mission

Within the framework of clinical trials conducted by Epicentre/MSF on Ebola caused by the Bundibugyo virus (BDBV) in the Democratic Republic of Congo (DRC) and potentially in other countries, the Clinical Research Associate (CRA) ensures the quality and regulatory compliance of studies in accordance with the applicable ICH Good Clinical Practice (ICH-GCP) guidelines, ensures 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 submitting 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.
  • According to the chosen organization:
  • Directly perform monitoring activities as a Clinical Research Associate (CRA), including site visits and the preparation of associated reports.
  • Select, train, support and supervise external monitoring providers for studies.
  • Review and approve monitoring reports.
  • Identify, document and escalate monitoring findings to study teams.
  • Ensure follow-up on the definition and implementation of corrective and preventive actions (CAPA).
  • Facilitate and organize all committees related to the study, including meetings and documentation (DSMB, Scientific Committee, as well as ad hoc teleconferences with various partners).

2. Support for quality management of studies

  • Contribute to the risk management process of studies (identification, assessment, mitigation, monitoring), in accordance with ICH-GCP principles and Epicentre’s quality system.
  • Ensure the implementation and maintenance of essential documentation for the quality management system of studies (ISF, TMF, source documents, standardized procedures and forms).
  • Provide support for training teams on study procedures and standard operating procedures (SOPs), both centrally and locally.

3. Support for safety review and pharmacovigilance activities

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

  • Verify the consistency and information contained in the serious adverse event (SAE) reports.
  • Ensure that EIG reports are submitted within the timeframes stipulated by the protocol.

4. Pharmaceutical management of investigational products

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

5. Support for project coordination

  • Supporting the Project Manager(s) in the coordination of studies:
  • Activity planning;
  • Monitoring of objectives, deliverables and milestones;
  • Coordination of meetings and steering committees;
  • Document management of studies.
  • Provide support to PIs (Principal Investigators) and study teams for the day-to-day management of trials.
  • Contribute to scientific monitoring related to Ebola trials.

Functional relationships

The ARC works closely with:

  • The Project Manager(s) in the DRC;
  • The operational and logistical teams of MSF and Epicentre;
  • The Lead Investigators;
  • The Pharmacy, Quality, Monitoring and Pharmacovigilance teams at Epicentre;
  • Institutional and regulatory partners.

Diploma

  • Master’s degree in public health, biology or equivalent scientific discipline, supplemented by training as a Clinical Research Associate (CRA).
  • A degree in pharmacy or medicine would be an asset.

Experience

  • Proven experience in monitoring phase 2/3 clinical trials, including independently conducting monitoring visits and following up on 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 to varied cultural contexts.
  • Ability to integrate effectively and collaborate within multidisciplinary and multicultural teams.
  • Strong organizational skills and ability to manage priorities in a demanding environment.
  • Strong preference for collaborative work in international and multicultural environments.
  • Rigour, sense of responsibility and ability to lead, support and supervise a team.
  • Available ASAP.

LANGUAGES

  • French and English, minimum level C1.
  • Additional informationConditionsPosition based in Paris with frequent international travel, primarily in Eastern DRC. Salary: €55,286 per year (13 months).Duration: Fixed-term contract of 12 months, renewableBenefits :
  • 25 days of paid leave + 22 additional days of leave
  • Meal vouchers (€12/day, 60% covered by Epicentre)
  • Health insurance covered 100%
  • 50% reimbursement of public transport tickets in Ile de France.
  • Due to administrative constraints related to the duration of the contract, candidates must already have a work permit 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 be working in a humanitarian environment
  • Your contributions and ideas will be valued and greatly appreciated.
  • You will participate in the life of the association and your tasks will evolve as your involvement increases.

How to apply

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

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

Epicentre is committed to protecting the personal data of its members, employees, and prospective members. The data collected during this application process will be strictly limited to those involved in the recruitment process, regardless of the location of the Epicentre branch to which they belong, ensuring fair and high-quality processing.