Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology, Ministry of Science and Technology, Govt, of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad, and is designed as a dynamic, interactive organization with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into tangible products to improve human health.
Post : Full time Senior Research Officer - Ethics
About the Project
CDSA is currently working on a project along with PATH and FERCI which aims to create a sustainable integrated electronic research application system that will empower medical / research institutions to enhance management of their research ethics review process, facilitate a common review process for multi-center research and empower researchers to improve quality of research proposals. A Clinical Research Advancement Towards Excellence (CReATE) software suite has been developed previously by PATH in collaboration with FERCI and this project will build on and expand the scope and reach of CReATE.
Emoluments : Up to Rs. 80,000 per month, consolidated for 36 Months subject to performance, initial contract for one year with six months’ probation period.
Job profile
The roles & responsibilities of Senior Research Officer are as follows but not limited:
A. Leadership and Strategy
Analyse market dynamics for the novel software tools for the ethics review process in the country, Develop marketing and revenue generation strategies for sustainable roll-out of the software solutions at the national level
B. Operations Management
Working with project leadership, develop and track detailed project plans including schedules, cost estimates, resource plans, communication plans, risk mitigation plans, and issue resolution plans.
C. Quality Monitoring
Monitor the uptake and feedback obtained from users of the software at is rolled out in the different institutes.
D. Communications
Provide project summaries and updates to the management and leadership teams. Communicate with members of ECs, institutions, PATH team, IT team and others on a regular basis to understand all project related developments and help with project advocacy.
E. Training
Will need to provide training to users of CReATE and help handhold them.
F. Research
Map policies and guidelines applicable to the research ethics review process in India. Undertake baseline, end line activities to analyse the impact of the project.
Essential Functions
Support the development of software scale-up strategies and tools.
• Map policies and guidelines applicable to the research ethics review process in India.
• Analyse market dynamics for the novel software tools for the ethics review process in the country.
• Contribute to the development user requirement specifications for enhancement of the software functionalities.
• Support external working groups, technical advisory, and scientific bodies as needed and appropriate.
• Contribute to CDSA and its partner’s development of updates, tools and materials for review and consideration by relevant stakeholders and steering committee.
• Manage timelines for development and scale-up processes.
• Support efforts for introduction of the software in new research institutions.
• Develop marketing and revenue generation strategies for sustainable roll-out of the software solutions at the national level
Coordinate interactions with key stakeholders for continuous engagement and monitoring.
• Track engagement with key stakeholders, including program partners, user institutions and IT developer in advancing the roll-out of the software solutions.
• Support engagement with expert advisory bodies in accordance with timelines.
• Organize and coordinate consultations and interactions with personnel from academia, industry and government to foster consensus on the evidence generated for utility of the software solutions.
• Prepare reports from meetings to inform the partners about meeting outcomes.
• Working with project leadership, develop and track detailed project plans including schedules, cost estimates, resource plans, communication plans, risk mitigation plans, and issue resolution plans.
• Provide project summaries and updates to the management and leadership teams.
Provide support to other initiatives of CDSA which are aimed at streamlining clinical research and associated ethics processes in India.
• Provide support and work with the CDSA team in managing current ongoing projects related to streamlining the clinical research ecosystem in India. Specifically projects related to development of the clinical trials toolkit, setting up a network of clinical research units and common review for multicenter trials.
Qualifications and Work Experience
Education
Essential: Master’s degree in public health, clinical research or related disciplines.
Desirable Degree in business administration will be added advantage, IT knowledge.
Work Experience
Essential: 3 years of experience in working in clinical research related projects of
which a minimum of 1 year is in India. This could include work in this sector as a part
of a pharmaceutical company, any private consulting company, NGO or directly with
government agencies
Experience of working with/demonstrated knowledge of ethical review processes in
India and an understanding of current developments in this sphere.
Desirable: Previous experience in supervising, supporting or working with computer IT professionals
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Age limit : Not exceeding 45 years
Location : CDSA, Faridabad (Haryana)
Skills
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, action oriented and resilience in a fast-paced and rapidly changing environment
• Business/ Operational skills that include commitment to problem solving, managing multiple stakeholder relationships and keeping track of the multiple deliverables and timelines of the project.
• Influencing skills including negotiation and teamwork
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Computer literacy in Word, Excel, PowerPoint, Access or other trial management systems
• Ability to develop and deliver presentations, prepare technical reports and contribute effectively in the manuscripts
• Ability to develop and implement monitoring plans and SOPs
• Ability to make evaluative judgments, remain flexible as projects and priorities change • Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects is desirable
• Ability to travel for business purpose.
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please walk-in for the interview along with two sets of latest passport photograph, current updated CV, Education qualification and Experience certificate on 17 December 2018 from 9:30 AM onwards at NCR Biotech Science Cluster, THSTI Building, 3rd Milestone, Gurgaon- Faridabad Expressway, Faridabad 121004. (For directions, please visit THSTI website at <thsti.res.in/contact_us.php> at CDSA, Faridabad (Haryana).
6. All the originals to be also brought along for verification.
7. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
8. All results will be published on our website and all future communications will be only through email
9. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
10. Canvassing in any form will be a disqualification.
CLINICAL DEVELOPMENT SERVICES AGENCY
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)
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