EndTB Clinical Trials Intern M/W

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.

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 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.

Professional skills

We are looking for an intern interested in research (particular interest in clinical trials and/or data management is a plus).

To apply for this internship, you must be at least in the process of completing a Bac+4 or Master 1 in a health or science field. An intern in the process of completing a Bac+5 or Master 2 would also be welcome.

If your education or previous experience has provided you with a good understanding of the international ethical and regulatory requirements of clinical research, this is an asset, but not a prerequisite.

Languages : Fluently spoken and written English (work mainly in English); Good level of French an asset

Position’s specificities

Status: 6-month full-time internship, based in Paris. Internship agreement obligatory.

Conditions: Compensation according to the level of studies (from € 4.48 /hour Bac +3 to € 6.55 /hour Bac +5 and above, gross). Restaurant vouchers with a face value of €9 (60% coverage by Médecins Sans Frontières). 50% of the public transport ticket is covered.

Desired start date: February or March 2023.