Recruitment notice no.: THS-C/RN/24/2024 Dated: 04 November 2024
1. BRIC-Translational Health Science and Technology Institute (THSTI) is an Institute of the Biotechnology
Research and Innovation Council, Department of Biotechnology, Ministry of Science & 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 products to improve human health.
2. BRIC-THSTI has built several inter-institutional collaborations and connectivity with industry supported
by well-trained teams of research and laboratory staff. THSTI has established various centres namely
(a) Centre for Maternal and Child Health, (b) Centre for Viral Therapeutics and Vaccines (c) Centre for
Tuberculosis Research (d) Centre for Microbial Research, (e) Centre for Immunobiology and
Immunotherapy (f) Centre for Drug Discovery (g) Clinical Development Services Agency (h)
Computational and Mathematical Biology Centre (i) Centre for Bio-design and Diagnostics. These
centres are strengthened by many core facilities viz. Bioassay Laboratory, Biorepository, Biosafety
Level -3 Lab, Data Management Centre, Immunology Core laboratory, Multi-OMICS facility,
Experimental Animal Facility, Vaccine design and Development facility, School of Innvoation in
Biodesign etc that serve as huge resources for the research programmes of THSTI and also the National
Capital Region Biotech Science Cluster and other academic and industrial partners.
3. This recruitment is to fill up the vacancies for project positions at Clinical Development Services Agency
(CDSA) center. CDSA is a niche center of THSTI established to facilitate development of affordable
healthcare products for public health diseases. It is the only public Centre in the country created with
a mandate to support and nurture cost-effective, high quality, not-for-profit technology-based
preclinical and clinical product developmentas well as support clinical research conducted by public
agencies. It works towards development of an eco-system for training and learning and work with
public sector institutions, and small and medium enterprises (SME) to translate innovative
technologies into medical products for public good.
The main objectives of CDSA are:
a) As an academic Clinical Research Unit, to undertake & provide end -to- end clinical study
support for investigators and SMEs in study planning, set up, conduct: project management,
monitoring, data management, safety reporting, analysis and report writing
b) Build research capacity and capability through high quality training in the area of clinical
development/trials and regulation
c) Support and strengthen clinical research environment in the country
d) Regulatory science and policy support: provide tools and approaches to support researchers,
regulators, health policy makers & industry
Applications are invited from eligible candidates to fill up the following positions:
1. Name of the post Project Research Scientist - I (Non-Medical)
Name of the Project Digoxin in patients with rheumatic heart disease – A randomized placebo –
controlled Trial
Emoluments Rs. 56,000/- +10,080/- (18% HRA) = Rs. 66,080/-
Age 35 Years
Duration Up to 15th March 2025
Minimum
Educational
Qualification and
Experience
• First Class Post Graduate Degree, including the integrated PG Degrees
OR
• Second Class Post Graduate Degree, including the integrated PG Degrees with
PhD
OR
• MBBS/BDS/BHMS/BAMS/BPT
AND
Minimum of two (2) years of relevant clinical trial/research monitoring or clinical
site coordinator experience.
Job profile
• The Project Research Scientist -I (Non-Medical)/Study Monitor/ Clinical
Research Associate (CRA) conducts monitoring visits for assigned trial protocol
and trial sites. Overall responsibilities are to ensure that the trial is being
conducted in accordance with the protocol, standard operating procedures,
good clinical practice, and applicable regulatory requirements.
• Performs site monitoring throughout the trial which involves visiting the trial
sites on a regular basis (site initiation to site closeout) in accordance with the
contracted scope of work.
• Performs quality functions and executes quality programs (clinical operations,
clinical laboratory) as per GCP/GCLP and regulations
• Completes appropriate therapeutic, protocol, and clinical research training to
perform job duties.
• Setting up the trial sites such that each center has the trial materials, including
the trial drug while ensuring all trial supplies are accounted for in the study.
• Administers protocol and related trial training to assigned sites and establishes
regular lines of communication with sites to manage ongoing project
expectations and issues.
• May provide training and assistance to junior clinical staff.
• Creates and maintains appropriate documentation regarding site
management, monitoring visit findings, and action plans by submitting regular
visit reports and other required trial documentation.
• Manages the progress of assigned studies by tracking regulatory/ IEC
submissions and approvals, recruitment, and enrolment, CRF completion and
submission, and data query generation and resolution.
• Verifying that data entered into the CRFs is consistent with participant clinical
notes (source data/ document verification)
• Writing monitoring visit reports.
• Filing and collating trial documentation and reports.
• Archiving trial documentation and correspondence.
• Evaluate the quality and integrity of trial site practices related to the proper
conduct of the protocol and adherence to applicable regulations.
• Escalates quality issues to the Quality Manager, Project Manager, and/ or
senior management.
• Work with the Clinical Portfolio Management department on other projects as
directed and with other internal departments on their requirements as and
when required.
Skills
• Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
• Computer skills including proficiency in the use of Microsoft Office
applications.
• Strong written and verbal communication skills including good command of
English required.
• Excellent organizational and problem-solving skills.
• Effective time management skills and ability to manage competing priorities.
➢ Last date of receipt of online application: 24
th November 2024.
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