Site Coordinator - Pune - Doctors Without
- Doctors Without
- 4 - 5 years
- Pune
- 3 years ago
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Job Description
Vacancy: Mission Specialized Activity Manager / Site 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 by armed
conflict, epidemics, natural and man-made disasters and exclusionfrom 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 respondto
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 Researchand
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 worlds 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. InIndia 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 initiativewhenappropriate
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: English, Local languages (Hindi and Marathi) desirable.
Qualifications:
Minimum Bachelor level qualification in Health Sciences, or a closely related field
Experience:
Minimum of 4-5 years working in the health research field
A previous clinical trial or research experience (essential)
Site management/ Project management experience at Clinical trial site
(essential).
Experience working on MDR-TB patient clinical documents (advantage)
Languages: English, Hindi & Marathi
Knowledge: Clinical trial regulations, ICH- GCP guidelines
Competencies: Site Coordination, SOP preparations, Clinical Trial Monitoring,
CAPA implementations Main Tasks & Responsibilities
Accountabilities :
Coordinating, monitoring and evaluating the proper functioning of a medical or paramedicalactivity
at mission level according to DWBI protocols, standards, and procedures, ensuring the
implementation of the activity (education and counseling sessions, defaulter tracing, strengthening
of support groups, linking with social actors, community awareness activities, etc.)
Participating in the definition of strategies, protocols and activities of the mission and the projects
for his/her activity by assessing mission needs according to the changing medical needs andcontext
(including definition of log frame and budget) and developing tools (e.g. training materials,
counseling and education protocols, flyers, flipcharts, games)
Monitoring and evaluating the activity at mission level by defining indicators, following up tools and
designing contingency plans in collaboration with the Project Activity Managers (if required)
Functionally supervising the Project Activity Managers concerned and providing technical support
through regular project visits. Ensuring consistency and promotes cross-learningamongthe projects
Supporting the HoM and Medco in representing DWBI before the Ministry of Health and other
(inter)national partners for any issue concerning the area of responsibility such as the national roll-
out of area strategies and lobbying for adequate human resources
Context Specific Accountabilities:
Undergo training in the protocol, trial procedures (including Investigational productand TB lab),and
GCP.
Support the Operational Research Coordinator and the central study coordinator in performing re-
training of Site staff as required.
Verify patient, drugs and data management is performed accordingto locallyestablishedprocedures
and study protocol/SOPs/guidelines
Review Worksheets and other trial documents daily to ensure process consistency and adequacy of
processes and instruments used for data collection.
Ensure data quality is of a high standard (i.e. performing source data verification in data entered in
Open Clinica).
Verify that the Informed Consent Forms are complete, dated, andsigned by the study personnelwho
obtained informed consent and the patient, and, if applicable, the parent, guardian, or legal
representative.
Verify that protocol deviation are properly documented and defined corrective/preventive actions
implemented.
Supervise pharmacy work to make sure the drugs have been stored in controlled temperature
environment as per trial SOPs.Conduct training of site staffs for trial related procedures.
Liaising with Pune based partners and service providers, including trial site.
In DWBI, liaising with support department heads and team members to ensure adequate level of
information and mobilize necessary support to the trial implementation
Maintain the Investigator Site File and Central Investigator File content regularly.
Verify responses provided to data queries generated by the central DM team and by the external
monitor are accurate.
Ensure Serious Adverse Event reports are submitted to sponsors and regulatory agencies as perthe
defined timelines.
Coordinate with TB and Clinical lab for sample pick up from the site and receiving results in
time.Support the external monitor during the monitoring visits.
Attend meetings related to the endTB trial, including at DWBI, clinical, academic, and community
forums.
Supervision and Management of reports and ensuring good team work of trial team in Pune.
Travel to Mumbai site if and when requested.
Benefits (Non-negotiable)
Monthly Gross Salary: INR 94,956 and Secondary Benefits as per policies:
13th Month Salary/ Festival Bonus
18 Annual Leaves
12 Casual Leaves
Other compassionate leaves
Medical Reimbursement including dependents
Duration: 12 Months (Renewable)
Location: Pune
Expected Start Date: 7th June 2021To apply please email your CV and motivation letter with the subject Ref: SiteCo(EndTB) to: ms**********i@br*****s.msf.org by 21st May 2021 10:00 pm.
ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW. www.msfindia.in
Job Classification
Industry: NGO, Social Services, Regulators, 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, DM in Clinical Pharmacology
Doctorate: Doctorate Not Required
Contact Details:
Company: Doctors WithoutAddress: 3rd Floor, Pitruchaya building , Sanghavi corporate Park, Near Wasan motors, Govandi east Mumbai - 400088
Location(s): Pune
Keyskills: Site Management Project Management Site Coordination ICH-GCP Guidelines Data Management MS Office Education Counseling Health Research Counselling ICH
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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