France: STUDY COORDINATOR (M/F) - Epicentre

Organization: Epicentre
Country: France
Closing date: 22 Sep 2014

Epicentre recruits a Study Coordinator (M/F)

Epicentre is a non-profit organization, created in 1987 by Médecins Sans Frontières, whose activities include research, field epidemiology and training, which groups health professionals specialised in public health and epidemiology. In 1996, Epicentre became a World Health Organization Collaborating Centre for Research in Epidemiology and Response to Emerging Diseases.Epicentre follows its activities from its headquarters in Paris and from its offices in Geneva, Brussels, Barcelona, New-York and research centres in Uganda and Niger.

****Mission and Responsibilities****

This position will support the execution of an international multicentre randomized therapeutic trial (END-TB for Evaluating New Drugs for multidrug-resistant TB) to evaluate short oral drug regimens for treatment of multidrug resistant tuberculosis in a pragmatic adaptive design. The trial is a collaborative project between Partners in health (PIH, Boston USA), Médecins Sans Frontières (MSF, Paris, France and Geneva, Switzerland), the Institute of Tropical Medicine (ITM, Antwerp, Belgium) and Epicentre (Paris, France) and is funded by UNITAID. The trial sites are in Georgia, Armenia, Kirghizstan, Mozambique, Lesotho, Kazakhstan, Haiti and Peru.

****Position****

The study coordinator will support the preparation of the MSF trial sites in Georgia, Armenia, Kirghizstan and Mozambique and the execution of the trial in these sites. This position is part of a four-person study team at Epicentre that also includes a co-investigator, the trial statistician, and the trial data manager. This position will be directly supervised by the Epicentre co-investigator. The study coordinator will also receive support from the trial manager (PIH, Boston).

****Main Activities:****

1. Participates in the recruitment of the trial staff in each MSF site: writing of job description and participation in the staff interview together with MSF.
2. Supports day-to-day preparation of the sites and implementation of the study protocol through detailed management charts incorporating tasks, timelines, personnel and progress, as well as through calls and email communication with the study team. Participates in the training of on-site trial staff according to the trial procedures.
3. Ensures that all necessary approvals from ethics committees, local authorities and local drug authorities are obtained before starting recruitment, and that all safety and progress reports are submitted on time.
4. Participates in the development of study-related documents: study operating procedures quality management plan.
5. Maintains a good working knowledge of applicable institutional guidelines for proper research conduct, International Code of Harmonization Guidelines, and other regulations, and makes sure all research components and study staff are adhering to such guidelines/regulations. This includes ensuring all site investigators have completed and provided appropriate documentation, including recent certificates of training on Good Clinical Practices.
6. Serves as the primary point of contact for the study Clinical Monitor for the MSF sites and transmits the monitoring visit reports to the trial manager and Epicentre co-investigator.
7. Verifies with the site coordinators and site principal investigators that all trial related documents are available on site in the trial master file according the ICH guidelines, that up-to-date versions of study documents are circulated to all site staff, and that accurate versions are being implemented to ensure standardization of activities across sites.
8. Serves as the key liaison between the trial manager, the Epicentre co-investigator and the trial staff on site to ensure that all required documentation is provided when necessary and that the trial site progress reports are sent on time to the trial manager and Epicentre co-investigator.

****Candidate requirement****

Essential

· Working experience in therapeutic trial as trial monitor, senior research assistant or trial coordinator;

· Good knowledge of Good Clinical Practices and the International Code of Harmonization Guidelines;

· Fluent in English;

· Flexible for regular travels to the sites: 1 to 2 visits per site per year (1-2 weeks) according to needs.

Desirable

· International working experience, especially in limited resource countries;

· Familiarity of multi-site clinical trials;

· Knowledge of tuberculosis clinical practices.

****Conditions****

• Position based in Epicentre, Paris, France (possibly Geneva or Brussels)
• Short term Contract : 18 months starting ****3^rd November 2014****
• Remuneration according to experience and Epicentre salary grid.

Applications should be made online, ****before 22 September 2014**** by completing the form available from the following link :http://www.epicentre.msf.org/en/job-opening

For complementary information about this position please contact: maryline.bonnet@epicentre.msf.org

How to apply:

Applications should be made online, ****before 22 September 2014**** by completing the form available from the following link :http://www.epicentre.msf.org/en/job-opening