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Operational Research Coordinator

General

Position: Operational Research Coordinator
No of vacancies: 1
Duration: 12 Months (Renewable)
Monthly Gross Salary: INR 1,45,790/-
Location: Mumbai / Pune
Expected Start Date: 04th July 2022
Closing date: 6th June 2022 by 10 PM
Application Form: https://forms.gle/R7qWpSa1S9XoMs447
Email to: msfocb.mumbai.recruitment@gmail.com

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 advocate 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 Bihar, Chhattisgarh, Delhi, Jammu and Kashmir, Maharashtra, and Manipur.

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 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 either in Pune or Mumbai, he/she will directly coordinate the activities of the Pune and Mumbai sites. He/she will be accountable for the overall conduction of the studies in India. The Operational Research coordinator will liaise with regulatory authorities and partners at the 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 Central study coordinator and Operations Responsible). He/She will take care of getting (and maintain) Ethic and Regulatory authorities’ necessary approval working in close collaboration with the Sponsor, the Country PrincipaI Investigator (PI) and the two Site PIs.

Accountabilities

Ensure the protection of the rights, safety, and welfare of all study participants and the safety of study staff.
Make sure the study is planned, set up, conducted, documented and reported according to the protocol, effective standard operating procedures (SOPs), GCP, and applicable international and national regulations.
Supervise regulatory submission and liaise as needed with EC and DCGI and ensure adequate follow up to facilitate expediting application review for approval
Oversee subject recruitment and study enrollment goals
In collaboration with the Coordinating PI as well as the Site PIs and under the guidance of the Sponsor team, ensure studies start-up activities, budget development, staff recruitment, are performed in a timely and accurate manner.
Provide and maintain education in GCP and other regulations that govern the research activities, as well as in study procedures, to site trial staff.
Support and guide the Internal Monitors to ensure that site trial staff adheres to the study procedures, verification procedures, audits and inspections procedures.
Collaborate and support the Coordinating PIs and the Site PIs in the preparation and timely submission of reportable adverse events to the DWBI Pharmacovigilance Unit, central research team, local authorities, and relevant ethics committees.
Interact with the logistic team as needed so that clinical trial requirements are met both in terms of space and processes.

Context Specific Accountabilities

Support the Sponsor, the Coordinating PI and the Site PIs in preparation of documents to obtain study approval from all local relevant authorities, including drug license importation and subsequent amendments
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.
Responsible for the ENDTB budget available at sites & participate in recruitment of site staff.
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 are 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 processes are followed up 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.
Maintain the Investigator Site File (ISF) and ensure that all the essential documents are filed in the TMF
Support the Site PIs and Coordinating PI for the submission of any amendment to protocol or ICFs for approval to local RA and EC bodies.
Ensure with the Site PIs that notifiable events are reported on time to the DWBI 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 and patients are followed up as per protocol and SOP
Should manage and also provide support to the endTB Clinical Research Site Coordinator in Mumbai and Pune for the conduction 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.
Support the site closure activities at the end of the studies and ensure that the ethics and regulatory requirements are fulfilled.

Requirements

Qualifications

Minimum Masters level qualification in Health Sciences/ Pharmacy/ Medicine, PHD would be an addaed advantages

Experience

Minimum 3 years of Interventional Clinical Trial experience as study coordinator or trial/operational manager (preferably also in Trial Site set-up and Study implementation). Clinical Research Coordinator Certification (CRCC) is an asset.
Excellent knowledge and understanding of Clinical Research Regulations (preferably in India) and GCP
Understanding of human Subjects Data confidentiality
Proficiency in Microsoft Office Applications, Internet Applications. Experience with electronic medical records and/or data capturing systems is desired
People Management , Effective Communication, Time Management and Problem solving skills
Experience in Tuberculosis Field Desirable
Scientific background

Specific Skills

Ability to multitask, 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.
Good Punctuality and ability to act with responsibility
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 and MS Excel) & reporting skills.

HR & Benefits (Non-negotiable)

Monthly Gross Salary: INR 145790 and 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