Médecins Sans Frontières, an international medical humanitarian association created in 1971, provides medical assistance to populations whose lives are threatened: mainly in the event of armed conflicts, but also of epidemics, pandemics, natural disasters or exclusion from care. The French section of MSF is present in about thirty countries.
We are looking for a endTB Clinical Trials Intern.
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 be the intern at Sponsor level of two clinical trials:
- endTB: completed enrollment of 750 MDR-TB patients and expected to end in 2023
- endTB-Q: currently enrolling XDR-TB patients (target 324 patients) and expected to 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 the Trial Manager, you will be part of the central operational team, including about 15 people (Central Study Coordinators, Biostatistician, Data Manager, Clinical Trial Pharmacist, Tuberculosis Laboratory Experts, Pharmacovigilance Manager, Clinical Trial Assistant), distributed among the various partners, some of whom are based in Paris.
You will support the central operational team with the clinical trial data management activities.
You will work closely with the 2 Central Study Coordinators (in charge of the daily follow-up of the country teams), Quality Assurance Officer, Data Manager and Biostatistician.
Main activities of the intern
Work with Data Manager and Central Study Coordinators to assist with data cleaning activities:
- Follow-up until resolution of the queries sent by the operational team to the sites (e.g. queries raised for discrepancies between the Case Report Form (CRF) and protocol, queries from reconciliations with laboratory results)
- Support the reconciliation of missing data and manual data review
- Support the primary results validation process
Support Central Study Coordinators at local level:
- Attend regular weekly calls between the sites and the Central Study Coordinators and support in writing and releasing the meeting minutes
- Other administrative tasks as needed
Work with Quality team at central level:
- Support Trial Pharmacist for the reference safety information review of investigational products used in endTB clinical trials
- Assist Central Team with the preparation training/presentation material
- Develop tracking tables and/or comprehensive visuals summarizing the most recurrent central activities
- Support the Quality Assurance Officer for study documents archiving in the Trial Master File
This list of activities may be adjusted.