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Operational Research Coordinator

General

Position: Operational Research Coordinator
Location of Job: Mumbai
Duration of the Job: 12 Months (renewable)
Monthly Gross Salary: INR 119,429/-
Closing Date: 5th June 2021
Expected Start Date: 1st July 2021
No. of vacancies: 01 (One)
Email: msfocb-mumbai@brussels.msf.org

Background

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 the effect of antibiotic resistance. We also respond to natural disasters and other emergencies, provide 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. Doctors 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

Main Purpose

The endTB Operational Research Coordinator will bring clinical research experience and be responsible for coordinating the endTB and endTB-Q clinical trials at the participating sites (Mumbai and Pune) in India. Based in Mumbai or Pune with frequent travels between the two cities, he/she will supervise the Site Coordinator in Pune and the Site coordinator based in Mumbai. He/she will be accountable for the overall conduction of the studies in India. The coordinator will liaise with regulatory authorities and partners at national level, as well as State and local level before and after the Studies approval as representative of the endTB project in India (under the supervision of the Project Coordinator). He/She will take care of getting (and maintain) Ethic and Regulatory authorities’ approval working in close collaboration with the Sponsor, the Country PrincipaI Investigator (PI) and the two Site PIs. During the study conduct, the endTB Operational Research Coordinator will support the Country PI and the Site PIs to facilitate and oversee overall clinical trial activities (with special focus on the Site where he/she is based). S/he will play a critical role in the conduct of the study to ensure compliance with the International Conference of Harmonization Good Clinical Practice (ICH-GCP), study protocol and all applicable regulatory and Ethics Committee requirements. S/he will work closely with the Sponsor team, the MSF program(s), all relevant local institutions (e.g. Ethics Committee and Regulatory Authorities) and ensure smooth operational activities of departments involved in clinical trial implementation at Site level (eg: clinical, laboratory, pharmacy).

Context Specific Accountabilities

With the support of the Mumbai project management team, the endTB Operational Research Coordinator will:

Be responsible to evaluate site capacity (material and staff) and identify efforts to be deployed to reach site initiation.
Support the Sponsor, the Coordinating PI, the Site PIs and the Site Coordinators in preparation of documents to obtain study amendments approval from all local relevant authorities, including drug license importation. Monitor study progress and prepare progress reports for EC/RA as required.
Review and ensure conformity with local requirements and GCP requirements all trial documents relevant to the site, including the study protocol, the patient information leaflet, informed consent form (ICF) etc
Ensure that all study staff is trained according to the protocol, operating procedures and GCP.
Ensure with the Site and Trial pharmacists that study drugs will be available at dispensing site according to trial schedule, are stored according to trial standards and that drug accountability is organized on recruitment site and at the pharmacy.
Ensure that quality assurances are in place according to the requirements set by the Analytical project manager from ITM (Antwerp, Belgium) for TB laboratories and with other laboratories for clinical lab tests.
Ensure the Investigator Site Files (ISF) are properly maintained at the Sites.
Ensure with the Site PIs that notifiable events are reported on time to the MSF Pharmacovigilance unit and to the relevant ethics committee(s) and regulatory authorities.
Ensure data is recorded, handled, stored and reported accurately and promptly and confidentiality is maintained.
Provide patient data (collected in eCRF, SAEs and other notifiable events) and pre-screening/screening logs to central research team and external monitor or any audit, when required.
Ensure study visits are organized within the Clinical trial required timeframe for all study participants.
Provide support and supervise the endTB Clinical research Site Coordinator in Mumbai and Pune for the conduct of the clinical trial.
Facilitate the visit of the external monitor at the Sites and ensure corrective actions and preventive actions indicated by the external monitor are timely implemented.
To be the focal point for any communications related to the EndTB trials in consultation with the Project Ops Responsible.

Requirements

Qualifications

Minimum Masters level qualification in Health Sciences/ Pharmacy/ Medicine, PHD would be an added advantage

Experience

Interventional Clinical Trial experience as study coordinator or study monitor (preferably also in Trial Site set-up and Study implementation). Clinical Research Coordinator Certification (CRCC) is an asset.
Comprehensive knowledge and understanding of Indian clinical research regulations and GCP
Thorough understanding of human subjects data confidentiality
Must have distinctive communication, time management, strategic thinking, negotiation and problem solving skills
Excellent organizational and coordination skills including ability to prioritize
Excellent collaboration skills and demonstrated ability to work across multiple organizations in pursuit a common goal and to engage credibly with senior counterparts across multiple sectors
Previous experience in Tuberculosis field desirable
Experience with electronic medical records and/or data capturing systems is desired
Scientific background

Specific Skills

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.
Demonstrates flexibility in taking up tasks outside of regular job responsibilities as required and aptitude for humanitarian medical work.
Essential computer skills (especially MS Office MS Word & MS Excel)
Excellent reporting skills.
Languages: Good Knowledge of English & Local Languages (Hindi , Marathi)

HR & Benefits (Non-negotiable)

Monthly Gross Salary: INR 119,429
Secondary Benefits as per policies:
- 13th Month Salary/ Festival Bonus
- 18 Annual Leaves
- 12 Casual Leaves
- Other compassionate leaves
- Medical Reimbursement including dependents