Operational Research Coordinator ( Mumbai /)
- Doctors Without
- 3 - 7 years
- Pune
- 2 years ago
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Job Description
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 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 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 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 in 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 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 Pharma co vigilance 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 time frame 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
Desired Candidate Profile
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.
Qualifications:
- Minimum Masters level qualification in Health Sciences/ Pharmacy/ Medicine, PHD would be an added advantage
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
Perks and Benefits
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
Duration 12 Months (Renewable)
Location: Mumbai / Pune
Expected Start Date: 18th July 2022
To apply please fill out the Application Form https://forms.gle/R7qWpSa1S9XoMs447 by 4th July 2022 by 10:00 pm. In case of any technical issue or query please reach out on : ms**********************t@gm**l.com
ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW. www.msfindia.in
Job Classification
Industry: NGO / Social Services / Industry AssociationsFunctional Area: Other,
Role Category: Other
Role: Other
Employement Type: Contract
Education
Under Graduation: Graduation Not RequiredPost Graduation: M.Pharma in Pharmacy, Medical-MS/MD in Tuberculosis & Respiratory Diseases / Pulmonary Medicine
Doctorate: Ph.D/Doctorate in Medicine
Contact Details:
Company: Doctors WithoutAddress: 3rd Floor, Pitruchaaya, Sanghavi Corporate Park, Off. B.K.S.D Marg, Near Wasan Motors Service station, Govandi East, Mumbai-400 088, INDIA
Location(s): Pune
Keyskills: project management GCP clinical trials pharmacovigilance PHD CRCC clinical research scientific background
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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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