Clinical Research Associate - Cra

Job Description

General Mission

As part of the clinical trials conducted by Epicentre/MSF on Ebola caused by the Bundibugyo virus (BDBV) in the Democratic Republic of the Congo (DRC), and potentially in other countries, the Clinical Research Associate (CRA) ensures the quality and regulatory compliance of studies in accordance with applicable International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines. The CRA conducts clinical monitoring activities, oversees the management of investigational products in collaboration with the responsible pharmacist, and contributes to the quality management system while providing operational support to project teams.

1. Coordination of Clinical Monitoring Activities

• Define, implement and follow up the monitoring plan using a risk-based approach.
• Develop study documentation for the submission of research protocols to local and national Ethics Review Boards (ERBs) and, when required, regulatory authorities.
• Plan and organize monitoring activities according to study budgets, timelines and requirements.
• Depending on the selected organization:
  • Conduct monitoring activities directly as a CRA, including site visits and preparation of monitoring reports.
  • Select, train, support and supervise external monitoring service providers.
  • Review and approve monitoring reports.
• Identify, document and escalate monitoring findings to study teams.
• Ensure the definition, implementation and follow-up of Corrective and Preventive Actions (CAPAs).
• Facilitate and organize all study-related committees, including meetings and associated documentation (DSMB, Scientific Committee, and ad hoc teleconferences with various partners).

2. Support to Study Quality Management

• Contribute to study risk management processes (identification, assessment, mitigation and follow-up) in accordance with ICH-GCP principles and Epicentre's quality system.
• Ensure the implementation and maintenance of essential quality management documentation for studies (ISF, TMF, source documents, procedures and standardized forms).
• Support the training of study teams on study procedures and Standard Operating Procedures (SOPs), both at central and site level.

3. Support to Safety Review and Pharmacovigilance Activities

Main responsibilities include, but are not limited to, in collaboration with the Pharmacovigilance Officer:

• Review the consistency and completeness of Serious Adverse Event (SAE) reports.
• Ensure that SAE reports are submitted within protocol-defined timelines.

4. Pharmaceutical Management of Investigational Products

• Ensure follow-up of regulatory registration procedures for investigational products when required.
• Verify the proper management, traceability and accountability of investigational products.
• Verify compliance with storage, distribution, use, return, reconciliation, inventory and destruction procedures for investigational products in accordance 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 cold chain requirements throughout the lifecycle of investigational products, including temperature monitoring, management of temperature excursions, associated documentation and compliance with applicable quality procedures, particularly in the logistically challenging environments of Eastern DRC.

5. Support to Project Coordination

• Support Project Manager(s) in study coordination activities:
  • Activity planning;
  • Tracking objectives, deliverables and milestones;
  • Coordination of meetings and steering committees;
  • Study document management.
• Provide support to Principal Investigators (PIs) and study teams for the day-to-day management of clinical trials.
• Contribute to scientific monitoring and literature review related to Ebola clinical trials.

Functional Relationships

The CRA works closely with:

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

Qualifications

Diplôme

• Master en santé publique, biologie ou discipline scientifique équivalente, complété par une formation d’Attaché(e) de Recherche Clinique (ARC).
• Un diplôme en pharmacie ou en médecine serait un plus.

Expérience

• Expérience confirmée en monitoring d’essais cliniques de phase 2/3, incluant la conduite autonome de visites de monitoring et le suivi de plans d’actions correctives et préventives (CAPA).
• Au moins 2 ans d’expérience professionnelle préalable dans des pays à ressources limitées, en contexte humanitaire ou dans des environnements opérationnels complexes.
• Une expérience avec MSF ou d'autres ONG est un plus.

Connaissances et compétences

• Excellentes capacités d’analyse, de synthèse, de rédaction et de communication.
• Aptitude à s’adapter à des situations complexes ou atypiques ainsi qu’à des contextes culturels variés.
• Capacité à s’intégrer efficacement et à collaborer au sein d’équipes multidisciplinaires et multiculturelles.
• Sens de l’organisation et aptitude à gérer les priorités dans un environnement exigeant.
• Goût prononcé pour le travail collaboratif dans des environnements internationaux et multiculturels.
• Rigueur, sens des responsabilités et capacité à encadrer, accompagner et superviser une équipe.
• Disponible ASAP.

Langues

• Français et anglais niveau C1 minimum.

Additional Information

Qualifications

• Master's degree in Public Health, Biology or a related scientific discipline, complemented by Clinical Research Associate training.
• A degree in Pharmacy or Medicine would be an asset.

Experience

• Proven experience in monitoring Phase II/III clinical trials, including the autonomous conduct of monitoring visits and follow-up of Corrective and Preventive Action (CAPA) plans.
• At least 2 years of prior professional experience in low-resource settings, humanitarian contexts, or complex operational environments.
• Previous experience with MSF or other NGOs is an asset.

Knowledge and Skills

• Excellent analytical, synthesis, writing and communication skills.
• Ability to adapt to complex or atypical situations and diverse cultural environments.
• Ability to work effectively within multidisciplinary and multicultural teams.
• Strong organizational skills and ability to manage priorities in demanding environments.
• Strong interest in collaborative work within international and multicultural settings.
• High level of rigor, accountability, and ability to guide, support and supervise team members.
• Available to start as soon as possible.

Languages

• French and English, minimum C1 level.

Job Conditions

Contract Type: 12-month fixed-term contract (renewable), full-time

Location: Paris, France, with frequent international travel, primarily to Eastern Democratic Republic of the Congo (DRC)

Start Date: As soon as possible

Salary: €55,286 gross annually paid over 13 months

Benefits:

• 25 days of paid annual leave + 22 additional leave days
• Meal vouchers (€12/day, 60% covered by Epicentre)
• 100% employer-funded health insurance
• 50% reimbursement of public transportation costs in the Paris region

Administrative Requirement: Due to administrative constraints related to the duration of the contract, applicants must already hold a valid authorization to work in France (European Union citizen or residence permit allowing employment in France).

Why Join Us?

• Be part of a multicultural team working in the field of epidemiological research.
• Contribute to meaningful work in a dynamic humanitarian environment.
• Have your ideas, expertise and contributions recognized and valued.
• Participate actively in the life of the organization and grow with an evolving role.

How to apply

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

Only shortlisted candidates will be contacted.

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

Epicentre is committed to protecting the personal data of its members, employees, and applicants. The data collected during this application process will be strictly shared with individuals involved in the recruitment process, ensuring fair and high-quality processing, regardless of the Epicentre structure’s location.