Clinical Trial Coordinator – ELDORADO Project (GHIGS)

Université de Bordeaux; Bordeaux; Hybride; EUR 50 000 - 70 000; Plein temps

Résumé du poste

L'Université de Bordeaux recherche un Coordinateur d'Essai Clinique pour un projet de recherche international sur le VIH. Le candidat supervisera la mise en œuvre d'essais cliniques complexes, garantissant la conformité aux normes. Des compétences en gestion de projet, avec une passion pour la recherche en santé mondiale, sont essentielles. Le poste offre 50 jours de congés et la possibilité de télétravail.

Prestations

50 jours de congé dès la première année

Télétravail possible

Participation aux frais de transport public

Couverture santé privée

Établissement accessible aux personnes handicapées

Qualifications

• Docteur en médecine requis.
• Intérêt fort pour la recherche clinique en santé infectieuse.
• Expérience souhaitée en gestion de projet et recherche clinique.

Responsabilités

• Superviser la mise en œuvre de l'essai clinique.
• Assurer la conformité avec les normes cliniques nationales et internationales.
• Coordonner les aspects médicaux de l'essai sur tous les sites.

Connaissances

Gestion de projet

Communication

Compétences analytiques

Formation

Doctorat médical

Description du poste

À propos de nous

The University of Bordeaux is a large, dynamic, and responsible university that is attentive to the well-being of its staff. Joining it means working in a privileged environment within a particularly diverse and open professional community, benefiting from support and inclusion programs, training, and internal mobility. It means taking part in an academic, scientific, and human adventure. It means committing to meeting the challenges of the 21st century.

The Bordeaux Population Health center is one of the leading population health research centers in France. It includes 10 teams (approximately 500 people) working on cross-disciplinary areas such as: brain health throughout life; data science (AI), molecular epidemiology, longitudinal cohorts, medico-administrative databases; infectious diseases and global health; aging and resilience; and environmental and social determinants of health.

Mission

The Clinical Trial Coordinator will be responsible for overseeing the clinical aspects of a European research project (EDCTP3) focused on HIV, conducted within the Bordeaux Population Health Research Center (GHiGS team, INSERM UMR 1219 – IRD EMR 271).

The core component of the project is a phase 3 clinical trial aiming to evaluate doravirine as an alternative to dolutegravir in antiretroviral treatment (ART)-naïve patients.

This trial, sponsored by ANRS | MIE, is being conducted across 19 investigational sites in six countries (Brazil, Cameroon, Côte d’Ivoire, Mozambique, France, and Thailand), as part of a broader EDCTP3 initiative. The project aims to assess the toxicity of dolutegravir—the WHO-recommended first-line ART—and evaluate doravirine as an alternative treatment option.

Main Activities

• Supervise trial implementation in close collaboration with national and site-level principal investigators.
• Coordinate and contribute to the development of clinical procedures for the main trial and sub-studies addressing metabolic disorders, organ damage (heart and liver), mental health, and quality of life.
• Adapt protocols and procedures in response to new medical needs or challenges, ensuring alignment with evolving standards of care.
• Ensure compliance with national and international clinical standards, with a strong focus on patient safety, protocol adherence, and consistency in medical procedures across all participating sites.
• Coordinate the medical aspects of the trial across all sites.
• Design, organize, and monitor the training plan for research staff, including webinars on managing metabolic disorders and alcohol-tobacco withdrawal.
• Coordinate and facilitate clinical meetings.
• Oversee the implementation and compliance of essential clinical research documents (protocols, CRFs, monitoring plans), both remotely and on-site.
• Coordinate validation and coding of key trial events and outcomes (medical criteria, endpoints, adverse clinical or laboratory events).
• Support investigators with the reporting and follow-up of Serious Adverse Events in collaboration with the sponsor’s pharmacovigilance unit.
• Contribute to data analysis, dissemination, and valorization of research results.
• Develop training materials and participate in the training of investigators and community advisory board members in participating countries.
  
  

Working Conditions

The position involves regular interaction with a wide range of stakeholders in France and internationally, including researchers, administrative teams, higher education institutions, laboratories, healthcare centers, NGOs, and ministries.

Fluency in English is essential, as the project is led by an international consortium and implemented across six countries in Europe, South America, sub-Saharan Africa, and Southeast Asia.

Effective project coordination is crucial, with strict adherence to established timelines.

Internal Contacts

• Central coordination team of the ELDORADO project (project lead, project manager, clinical research associates, data manager, statistician, communications officer)
• French coordinator of the clinical coordination work package
• Technical services of Unit U1219
  
  

External Contacts (France and international)

• International coordinators of the clinical coordination work package
• Project investigators outside the University of Bordeaux
• Principal investigators and co-investigators at national and site levels
• Project partners: universities, research organizations, hospitals, laboratories, NGOs
• Institutional partners such as WHO and national institutions leading HIV programs
  
  

Profil

A medical doctorate is required for this position. A strong interest in clinical research, particularly in infectious diseases and global health, is expected. Familiarity with research contexts in low- and middle-income countries is desirable; field experience would be a valuable asset.

The candidate must have a solid command of clinical trial methodology and biomedical research regulations (Good Clinical Practice and applicable legislation), as well as a good understanding of HIV and its associated comorbidities. Fluency in both French and English, written and spoken, is essential. Knowledge of Portuguese is an advantage.

Experience in project management, team supervision, and collaborative work with various stakeholders is desired. The candidate should demonstrate rigor, autonomy, strong writing skills, analytical and synthesis abilities, and the capacity to work under tight deadlines.

Previous experience in clinical research is highly valued.

Job Benefits

50 days of vacation from the first year of collaboration

Remote working possible according to needs and organization of the service

Refill of 75% of the subscription to the public transport

Participation in the private healthcare up to 15€ / month

Leisure, sport and culture for all staff

Disabled-friendly establishment

Possibility of staff parking

Sustainable mobility package for commuting – work

Recruitment process: Applications are reviewed as they arrive.

Candidates selected for an interview will be contacted by the Recruitment Officer for a first pre-qualification phone conversation. An interview with the supervisor will then be organised by videoconference.

Référence de l'offre : m76zab6cqp