France

Médecins sans frontières recruits 01 Clinical Research Associate

Médecins sans frontières recruits 01 Clinical Research Associate (M/F)

Description Contexte :

In 1995, Epicentre created a permanent research center in Uganda. The primary role of Epicentre in Mbarara is to conduct clinical research following Good Clinical Practice (GCP) requirements on critical public health burdens in Uganda and Africa. At present, the Mbarara Epicentre Research Centre is conducting 3 vaccine trials.

The Clinical Research Associate will work closely with the team in Mbarara, Uganda and Paris, France and will support the conduct of the 3 vaccine trials and ensure compliance with clinical trial protocols and GCP.

 

Activités principales :

  • Preparation of protocols and regulatory support:
  • Organizes and develops study related documents for submission of research protocols and any additional amendments to Ethics Review Boards (ERBs) and regulatory authorities
  • Ensures proper contracts and documentations have been completed, communicated and any problems resolved and discussed
  • Facilitates and organizes of all study related boards and committees including meetings, documentation and reimbursement contracts (DSMB, Scientific Committee, as well as punctual teleconferences with diverse partners)
  • Diffuses results to relevant partners and stakeholders
  • Participate in writing technical trial reports, including annual reporting to ERBs, MSF and partners

 

  • Conduct of research :
  • Identifies and assesses the suitability of facilities to use as the clinical trial site
  • Ensures agreed upon hiring necessary to complete the project is conducted in a timely manner
  • Regularly communicates with site instigators and vaccine trials coordinator to follow-up on the implementation of the trials and provide support and recommendations
  • Monitors the trials throughout their duration, which involves visiting the trials sites on a regular basis
  • Writes visit reports and follows-up on the action points
  • Ensures the trials sites have the necessary materials, including investigational products, for the conduct of the studies, and follows-up on the accountability and ordering
  • Participates in the training of the site personnel
  • Helps in the development of Standard Operating Procedures and their revision as necessary
  • Liaises with personnel in Paris office or outside to follow-up on specific issues, such as pharmacovigilance, laboratory activities, data management and statistics.
  • Follow-up and revise budgets in coordination with finance team

 

  • Project Closeout and Communication :
  • Prepares submission of accurate and timely closeout documents to ERBs, MSF and external funders as appropriate
  • Coordinates report diffusion to relevant partners and stakeholders with confirmation
  • Ensures adequate final accountability of investigational products
  • Supports the sites teams on the closures of the study site
  • Coordinates the archiving of study documentation and correspondence

 

  • Participates in Epicentre and MSF activities :
  • Maintains and nurtures an interest in our collective activities and in the development of the organization as well as our guiding principles with respect to the conduct of research in vulnerable populations
Ville PARIS
Expériences / Formation du candidat Prérequis :

  • Training in public health, epidemiology or clinical research with clear track record in GCP compliance
  • Relevant working experience in international clinical trials, MSF or another international NGO
  • Fluent in English, French desirable
  • Excellent communication skills, both in speech and writing
  • Excellent organizational and record-keeping skills
  • Willing to travel
  • Comprehension of various software programs
  • Able to be flexible and adapt to a changing environment and tight deadlines
Experience 0 à 3 ans
Fonctions Plaidoyer et Recherches, Gestion de projets/programmes
Secteurs d’activité Santé
Pays Europe, France
Salaire / Indemnité Conditions :

  • Poste based in Paris with frequent trips to Uganda and is expected to start as soon as possible
  • Short-term Contract: 12 months
  • Starting date: as soon as possible
  • Remuneration: between 48K€ annual gross salary; 22 extra days off, health insurance, reimbursement 50 % of public transport title, meal voucher
Comment postuler To apply : https://smrtr.io/3xHDn
Date de fin de validité 04/11/2019

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