Clinical Trial Support Half-time– endTB project M/F

Mission

endTB is a project that aims to provide access to new treatments for patients with multi-drug resistant tuberculosis (MDR-TB). The project is conducted in partnership, within a consortium (involving MSF, Partners in Health (PIH) and Interactive Research and Development (IRD)), a research partnership (involving Harvard Medical School (HMS), Institute of Tropical Medicine-Antwerp (ITM) and Epicentre) and an additional contract with University of California San Francisco (UCSF). The project is co-funded by Unitaid and some consortium partners.

You will participate in the management of two Phase III randomized clinical trials aimed at determining the safety and efficacy of new therapeutic regimens for MDR-TB patients: – endTB for which the 750 MDR-TB patients are now enrolled and which will end in 2023, – endTB-Q for which one thirds of the 324 XDR-TB patients are still to be enrolled and which will end in 2024.

Both clinical trials are conducted under the responsibility of MSF France as Sponsor in 11 sites in 6 countries: India (MSF project), Peru, Kazakhstan, Lesotho (PIH projects), Pakistan (IRD project) and Vietnam (UCSF project).

Reporting to Clinical Trials Manager, you will be part of the central operational team, including about 15 people, distributed among the various partners, some of whom are based in Paris. This team includes: 1 Clinical Trials Manager, 3 Central Study Coordinators (in charge of the daily follow-up of the country teams), 1 Quality-Assurance Officer, 1 Clinical Trials Pharmacist, 1 Data Manager, 1 Biostatistician, 3 Pharmacovigilance Officers, 2 Tuberculosis Laboratory Experts and 1 Clinical Trials Support (the position opened here).

You may also be required to interact with the Project Director/Principal Investigator and the Project Manager on an ad hoc basis, and more regularly with the Project Assistant (in support of administrative, financial, communication and partners management aspects).

Job requirements Education: 3 years of higher education required. Training in the field of Clinical Research.

Experience: Minimum 3 years experience as a Clinical Research Assistant – essential. Knowledge of the ethical and regulatory requirements of clinical research – essential. Experience in international multi-center clinical trials – preferred. Knowledge of MSF is a plus but not essential.

Languages: Professional written and spoken English – essential. Good level of French – appreciated.

Specificities of the position

Status: 6 months fixed term contract, part time (50%). Position based in Paris, metro Jaurès. No travel.

Desired start date: July 18, 2022.

Salary conditions: 38.2K€ gross annual salary over 13 months based on a full-time contract. Health insurance 100% covered by MSF. Restaurant vouchers with a face value of 9€ (60% paid by MSF). 50% of public transport pass paid.