International clinical study coordinator

European Commission; France; Sur place; EUR 35 000 - 50 000; Plein temps

Résumé du poste

Une organisation de recherche en santé publique recherche un coordinateur d'étude clinique pour le projet PROMISE-ZERO. Le candidat idéal devra avoir une expérience en gestion de projets, être bilingue en français et anglais, et avoir une forte connaissance de l'infectiologie, notamment du VIH. Le poste est basé à Montpellier, avec des responsabilités variées allant de la planification à la supervision de l'étude dans un cadre multinational.

Qualifications

• Expérience en gestion de projets de recherche clinique
• Connaissance en infectiologie, notamment le VIH
• Capacité à travailler en équipe et à communiquer efficacement

Responsabilités

• Planifier et coordonner l'implémentation de l'étude PROMISE-ZERO
• Assurer la conformité réglementaire tout au long de l'étude
• Participer à la formation du personnel impliqué dans l'étude

Connaissances

Gestion de projet

Connaissance de l'infectiologie

Compétences interpersonnelles

Communication (oral et écrit)

Bilingue Français/Anglais

Formation

Diplôme en sciences biomédicales ou domaine similaire

Outils

REDCap

STATA

Microsoft Office

Description du poste

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Pharmacological sciences » Clinical pharmacology

Organisation/Company Universite de Montpellier Department Human Resources Research Field Pharmacological sciences » Clinical pharmacology Researcher Profile Recognised Researcher (R2) Positions Research Support Positions Country France Application Deadline 24 Aug 2025 - 23:59 (Europe/Paris) Type of Contract Temporary Job Status Full-time Is the job funded through the EU Research Framework Programme? Horizon Europe Reference Number 2025-R0393 Is the Job related to staff position within a Research Infrastructure? No

Offer Description

- work environment: The principle of our research unit is to harbor under the same roof the different domains of research contributing to the common goal of improving care and prevention of chronic and emerging infections: cognitive (basic science), translational and clinical research. A multidisciplinary approach and organization is prioritized in order to benefit as much as possible from synergy inside and outside the unit and to maximize the opportunities to benefit from support of national, European and international funds in global research projects. The research project you will be working on is an implementation study comprising a cluster randomized clinical trial, a social science component based on the RE-AIM model, a health economics component and an environmental impact component. The main objective is to evaluate the efficacy of an optimized strategy to prevent postnatal transmission of HIV from mother to child at 18 months. The intervention consists in offering an HIV diagnostic test to children exposed at the Point of Care during vaccination visits at 6 weeks and 9 months. HIV-exposed uninfected children and their mothers will be eligible for the clinical trial. In the intervention arm, mothers will benefit from Point of Care viral load monitoring at 6 weeks and 9 months. Post-natal prophylaxis (lamivudine) will be initiated for children whose mothers have an unsuppressed viral load. In the control arm, participants will follow national recommendations. This project is implemented in rural Zambia.

- main mission: You will be responsible for planning and coordinating the implementation and follow-up of the PROMISE-ZERO study. This includes regulatory, financial, logistical, administrative, organizational and human aspects. You will work under the direct responsibility of the study's principal coordinating investigators.

- activities:

• Contribute to the development and timely review of project plans and tools.
• Conduct a literature review specific to the research project.
• Participate in the drafting and updating of study documents such as the protocol, participant information and consent form and study procedures.
• Demonstrate leadership in identifying, recommending and implementing improvements to policies and processes; define best practices.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Help organize meetings of the various committees involved in the study (steering committee, scientific committee, etc.)
• Participate in the training of study personnel, particularly in the areas of ethics and participant protection, research protocol procedures and good clinical practice,
• Set up and supervise the medication circuit and other devices as required.
• Oversee subject recruitment and retention objectives.
• Contribute to the development of data organization, collection, communication and tracking systems.
• Collaborate with the study team, principal investigators and sponsor in the monitoring and reporting of serious adverse events.
• Report regularly to the various partners on the progress of the project.
• Participate in regulatory, administrative, logistical, financial and scientific aspects of project closure.
• Participate in the analysis, communication and exploitation of research results.
• Ensure a continuous supply of laboratory consumables (at the recruiting site).
• Good general knowledge of infectiology and HIV infection in particular.
• Familiarity with the conduct of clinical trials in resource-limited countries, and knowledge of social science methodology would be a plus.
• Fluency in English and French: international experience appreciated.
• Proficiency in Microsoft Office applications and databases (REDCap, STATA/R).
• Knowledge of medical terminology
• Sense of responsibility
• Ability to communicate and manage relations with internal and external contacts at both technical and operational levels.
• Ability to work as part of a team
• Excellent oral and written communication skills
• Thoroughness
• Take initiative and make decisions
• Strong interpersonal skills
• Detail-oriented

Number of offers available 1 Company/Institute Pathogenesis and Control of Chronic and Emerging Infections (PCCEI) Country France City Montpellier Geofield