THSTI Faridabad Recruits Bioinformatian/Clinical Research Associate

BRIC-Translational Health Science and Technology Institute (THSTI)

Recruitment notice no.: THS-C/RN/17/2024 Dated: 12 August 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 candidatesto fill up the following positions: 

Name of the post Research Scientist (Bioinformatics) 

Name of the Project Clinical Development Services Agency - CDSA 

Emoluments Rs. 1,10,000/- 

Duration One Year Age 40 years 

Minimum Educational Qualification and Experience 
Essential qualification and work experience: MD or MVSc or M. Tech with minimum 2 years’ relevant post qualification research experience OR PhD in Life Sciences/ Computational Science/ Bioinformatics/ Genomics from a recognized University with minimum 6 months relevant post qualification research experience. 

Desirable: Work experience in metagenomics and bacterial genomics. 

Job profile Research and support to the ongoing big data analysis or next generation DNA sequencing data analysis or Proteomics and metabolomics data analysis 

2. Name of the post Clinical Research Associate 

Name of the Project DBT Neo-Sepsis 

Emoluments Rs. 60,760/- Duration Up to 31st March 2025 (can be extended further) 

Age 35 Years 

Minimum Educational Qualification and Experience 

Bachelors in Life Sciences with minimum three years of relevant clinical trial monitoring experience. OR 
• Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline with minimum 2 years of relevant clinical trial monitoring experience. 
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred 

Job profile The Study Monitor/ CRA conduct 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 contracted scope of work. 
• Performs quality functions and executing 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 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 on to the CRFs is consistent with participant clinical notes (source data/ document verification) 
• Writing visit reports and Filing and collating trial documentation and reports. 
• Archiving trial documentation and correspondence. 
• Evaluates 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 Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required. 

Skills: - 
• Computer skills including proficiency in use of Microsoft Office applications 
• Basic knowledge and ability to apply GCP and applicable regulatory guidelines. 
• 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: 01st September 2024. 

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