- Position: Clinical Tial Executive (EndTB Trial)
- Location of Job: Pune
- Duration: 12 months (Renewable)
- Start Date: 22 February 2021
- Closing date: 5 February 2021 until 5:30 PM
- No. of vacancies: 01 (One)
- Email: email@example.com
Doctors Without Borders / Medecins Sans Frontieres (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, natural and man-made disasters and exclusion from healthcare in more than 70 countries. DWB offers assistance to people in need and irrespective of race, religion, gender or political affiliation.
Doctors Without Borders has worked in India since 1999, providing free-of-charge essential healthcare to people in remote areas; treatment and care for people affected by HIV/AIDS, malnutrition; hepatitis C, tuberculosis, kala azar and sexual and gender-based violence; an important subject for our action is containing effect of antibiotic resistance. We also respond to natural disasters and other emergencies, provides mental healthcare and advocates for the development of more effective and affordable medicines to improve access to treatment everywhere.
Doctors Without Borders was awarded the Indira Gandhi Prize for Peace, Disarmament and Development in 1996 and the Nobel Peace Prize in 1999.
Doctor Without Borders India (DWBI) runs projects in the states of Andhra Pradesh, Bihar, Chhattisgarh, Delhi, Jammu and Kashmir, Jharkhand, Maharashtra, Manipur, and Telangana.
Doctors Without Borders India (DWBI) and the endTB project
Doctors Without Borders, and its partners i.e. Partners In Health (PIH), Interactive Research and Development (IRD), Epicentre, France, Institute of Tropical Medicine, Belgium and the Harvard Medical School have launched two major clinical trials, endTB and endTB-Q which seek to revolutionize treatment for the toughest strains of tuberculosis (TB), the world’s leading infectious disease killer. The goal of these studies is to generate high quality evidence from a highly heterogeneous population that could lead to a change in the global recommendations for the management of MDR-TB.
The endTB trials are multi-country, randomized, controlled, Phase III clinical trial testing five new, all oral, shorter duration regimens compared to the current standard of care. The aim of the trials is to find shorter, less toxic and injection-free treatments for ‘multidrug-resistant TB’ (MDR-TB). The experimental regimens mainly rely on newly approved or repurposed drugs and avoid drugs to which high rates of resistance have been reported in MDR-TB patient populations. These multi-country trials are being conducted in Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa and Vietnam. In India the trials are conducted at Mumbai and Pune sites by Doctors Without Borders India (DWBI) in Partnership with ICMR- National AIDS Research Institute (NARI) and in support with National Tuberculosis Elimination Program (NTEP).
Main Tasks & Responsibilities
The candidate will be required to ensure that the activities performed in the clinical trials are in line with the protocols, the regulations and that the study documentation is of quality and compliant with the trial framework. He /She will second the Site Study Coordinator on the various tasks associated with running multisite complex clinical trials. Generally, he/she is responsible for the day to day management of the project and assisting the project team in the start-up (including briefings), execution and closeout of the trial.
Among the responsibilities of the Clinical Trial Assistant are the following (the list is not exclusive)
- Preparation phase: Assist in the preparation of study documentation (protocol submissions to ethics committees, regulatory institutions), forms and the development filing systems and processes (documentation of the study, compliant with trial regulations).
- Ensure that updated study documents are available to investigators and site staff, and accountable for the management of non-clinical study materials and supplies. Prepare Investigator meetings, prepare study-related presentation materials and provide administrative technical support to study team
- Responsible for the maintenance and filing of study data, and files, and assist with the collection, review, and tracking of regulatory documents and safety data
- Assist project team with other study-related activities such as organizing study meetings and reviewing the documents under the supervision of the site coordinator, producing agendas and minutes for study-related meetings, assembling training and study materials, updating contact details, maintaining study documentation, assisting in the preparation of administrative documents and other tasks as required.
- Assist site team in setting up study clinics, identifying the needs and requirements for supplies follow up for the purchase orders and contracts.
- Ensure smooth communication between the trial team and the regular project team
- Maintain a flexible approach and responds to the needs of the project even if outside of this job description.
- Record and report adverse and serious adverse events to DCGI, Ethics Committee, and Sponsor and answer the queries raised by them in the stipulated period.
- Liaise with the study physician and Principal Investigator to prepare the safety reports and assessment of the causal relationship between drugs and adverse events.
- Degree in Health Science/ Pharmacy.
- A professional certificate/ diploma in a clinical trial will be desirable.
- 2-3 years of experience in clinical trials
- Ability to organize and prioritize workload & taking initiative when appropriate
- Able to integrate into a multi-cultural team and cooperate with co-workers
- Able to work independently as well as part of a team and ability to cope with stress.
- Ability to act with responsibility
- Demonstrates flexibility in taking up tasks outside of regular job responsibilities as required
- Aptitude for humanitarian medical work.
- Excellent reporting skills.
- Languages : English essential. Local languages ( Hindi and Marathi) desirable.
HR & Benefits (Non-Negotiable)
- Monthly Gross Salary: INR 46,368/-
- Secondary Benefits as per policies:
- 13th Month Salary/ Festival Bonus
- 18 Annual Leaves
- 12 Casual Leaves
- Other compassionate leaves
- Medical Reimbursement including dependents
- Personal Accidental Insurance including dependents
Please note that this job is referred to as “Medical Coordinator Assistant” in DWBI’s Function Grid, but the responsibilities are those of a Clinical Trial Executive.
To apply please email your CV and motivation letter with subject Ref: Medical Coordinator Assistant
by 5th February 2021, 11:00 pm.