Operational Research Coordinator - Mumbai
- Doctors Without
- 3 - 6 years
- Mumbai
- 3 years ago
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Job Description
Vacancy: Operational Research Coordinator (for our EndTB Trial)
No. of Vacancies-1
Doctors without Borders IndiaDoctors Without Borders/ Medecins Sans Frontieres (MSF) is an international, independent, medical
humanitarian organisation that delivers emergency aid to people affected byarmedconflict, 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 Bihar, Chhattisgarh, Delhi, Jammu
and Kashmir, Jharkhand, Maharashtra, 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 theHarvardMedical
School have launched two major clinical trials, endTB and endTB-Q which seek to revolutionize
treatment for the toughest strains of tuberculosis (TB), the worlds leading infectious diseasekiller.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 trialsistofind
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, SouthAfrica 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).
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.
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 & MS Excel)
Excellent reporting skills.
Languages:Good Knowledge of English & Local Languages (Hindi , Marathi)
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
Duration: 12 Months (Renewable)
Location: Mumbai
Expected Start Date: 1st July 2021 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 Stateand local
level before and after the Studies approval as representative of the endTB project in India (underthesupervisionof
the Project Coordinator). He/She will take care of getting (and maintain) Ethic and Regulatory authoritiesapproval
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 safety of study staff.
In collaboration with the Coordinating PI as well as the Site PIs and under the guidance of the Sponsorteam,
ensure studies start-up activities, budget development, staff recruitment, are performed in a timely and
accurate manner.
Oversee subject recruitment and study enrollment goals.
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 nationalregulations.
Support the Internal Monitors and the two Site Coordinators to ensure that site trial staff adheres to the
study procedures, verification procedures, audits and inspections procedures.
Collaborate and support the Coordinating PI and the Site PIs in preparation and timely submission of
reportable adverse events to the MSF Pharmacovigilance Unit, central research team, local authorities,and
relevant ethics committees.
Assist in site budget development and payment request submission.
Interact with the logistic team so that clinical trial requirements are defined and met both in terms of space
and processes.
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 reachsite
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, includingdrug licenseimportation.
Monitor study progress and prepare progress reports for EC/RA as required.
Review and ensure conformity with local requirements and GCP requirements all trial documentsrelevant to
the site, including the study protocol, the patient information leaflet, informed consent form (ICF) etc
Manage translations, as required .
Responsible for the EndTB trial budget and participate in the monthly forecast exercise.
Participate to recruitment of site staff as needed.
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.
Benefits (Non-negotiable)
Monthly Gross Salary: INR 119,429 and Secondary Benefits as per policies:
13th Month Salary/ Festival Bonus
18 Annual Leaves
12 Casual Leaves
Other compassionate leaves
Medical Reimbursement including dependentsTo apply please email your CV and motivation letter with the subject Ref: ORC(EndTB) to: ms**********i@br*****s.msf.org by 5th June 2021 10:00 pm.
ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW. www.msfindia.in
Job Classification
Industry: NGO / Social Services / Industry AssociationsFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Not mentioned
Role: Not mentioned
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any SpecializationPost Graduation: M.Pharma in Any Specialization, Medical-MS/MD in Any Specialization, MS/M.Sc(Science) in Any Specialization
Doctorate: Ph.D in Any Specialization
Contact Details:
Company: Doctors WithoutAddress: 3rd Floor , Pitruchaya Building, Sanghavi Corporate Park, Near Wasan Motors, Govandi East Mumbai -88
Location(s): Mumbai
Keyskills: Clinical Research Project Management Clinical Trials GCP Pharmacy Healthcare Pharmacovigilance ICF Phd RA
Doctors Without
Médecins Sans Frontières (MSF)/Doctors Without Borders 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 65 countries...
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