THSTI Clinical Research Project Openings


RECRUITMENT NOTICE NO.: THS-C/RN/12/2026 Dated: 12 th May 2026 

RECRUITMENT NOTIFICATION 

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, 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 Virus Research, 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 Innovation in Bio design 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. BRIC-THSTI trains the next generation of scientific leaders through many ambitious and globally competitive academic courses which promotes research and innovation through multi-disciplinary academia-industry partnerships. 

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 development as 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. 

CDSA 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. 

4. This recruitment is to fill up the vacancies of BRIC-THSTI under the following projects: 

Educational Qualification and Experience required for the post: 

1. Name of the post Research Officer 

Name of the Project Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment (ATT) and macronutrient supplementation on body weight, nutritional outcomes, and quality of life in adults with newly diagnosed drug-sensitive NAAT-positive Pulmonary Tuberculosis: An open-label randomized controlled parallel-arm clinical study 

Emoluments Rs. 67,000/- + HRA 

Age 40 years 

Minnimum Educational Qualification and Experience 

• Post Graduate Degree, including the integrated PG degrees, in any branch of Life Sciences with three (3) years post qualification experience in clinical trial monitoring. OR 
• PhD with experience in clinical trial monitoring. 

Job profile The Research Officer plays a pivotal role in supporting the execution and management of clinical trials across all stages. Working under the direction of the Project Manager and study monitors, they ensure the smooth operation of daily trial activities, maintain regulatory and trial documentation, and coordinate communication and logistics across study stakeholders. This role is expected to work independently on assigned tasks, proactively identify potential issues, and propose process improvements. 

Key Responsibilities: 

Clinical Trial Support & Documentation 
• Coordinate and track the distribution and reconciliation of clinical trial supplies, laboratory kits, and investigational products to investigational sites. 
• Ensure timely delivery and tracking of essential study documents and materials in accordance with study timelines and site activation plans. 
• Maintain and regularly update trial tracking tools (e.g., enrollment logs, regulatory document trackers, training logs). 

Regulatory & Site Start-up Support 
• Support CRAs and site staff in the collection, review, and tracking of essential regulatory documents for ethics committee and regulatory authority submissions. 
• Assist in preparing site initiation packages and supporting site readiness for activation. 
• Liaise with regulatory, legal, and contracts departments to ensure timely processing of site contracts and confidentiality agreements. Trial Master File (TMF) Oversight 
• Lead TMF set-up and ongoing maintenance, ensuring completeness, accuracy, and audit-readiness of clinical documentation. 
• Perform periodic TMF quality control (QC) checks and contribute to TMF metrics and reconciliation activities. 
• Support the development and implementation of TMF filing plans and oversight reports. Meeting Coordination & Communication 
• Schedule, coordinate, and document clinical team meetings, site communications, and teleconferences; maintain meeting agendas and minutes. 
• Assist with the organization and execution of investigator meetings, including logistics, preparation of materials, and follow-up documentation. 

Data & Site Management 
• Support CRAs with clinical data flow, Case Report Form (CRF) tracking, and resolution of data queries with investigational sites. 
• May accompany CRAs on monitoring visits to gain on-site experience and provide additional support during critical phases of the trial. Cross-functional & Operational Support 
• Serve as the central point of contact for the clinical team regarding projectspecific communications and documentation. 
• Collaborate with Clinical Portfolio Management, Regulatory Affairs, Data Management, and Quality Assurance to ensure alignment of deliverables. 
• Support budget tracking, invoice verification, and financial documentation coordination related to trial expenses and vendor contracts. 

Quality & Compliance 
• Ensure adherence to ICH-GCP, applicable regulatory requirements, and internal Standard Operating Procedures (SOPs). 
• Participate in internal and external audits and inspections as needed; support audit readiness and CAPA (Corrective and Preventive Action) implementation. 
• Contribute to internal quality initiatives and process optimization efforts. 

Skills 
• Strong understanding of ICH-GCP guidelines and clinical trial lifecycle. 
• Experience working with electronic Trial Master File (eTMF), Clinical Trial Management Systems (CTMS), and document management platforms. 
• Excellent communication, organizational, and problem-solving skills. 
• Detail-oriented with the ability to manage multiple tasks and prioritize effectively. 
• Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).

Date of walk-in interview for Sr. No. 1: 25th May 2026 @ 09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001 


2. Name of the post Project Manager (Monitoring) 

Name of the Project Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment (ATT) and macronutrient supplementation on body weight, nutritional outcomes, and quality of life in adults with newly diagnosed drug-sensitive NAAT-positive Pulmonary Tuberculosis: An open-label randomized controlled parallel-arm clinical study 

Emoluments Rs. 78,000/- + HRA 

Age Up to 45 years 

Minimum Educational Qualification and Experience Essential qualifications and work experience: 

• Post Graduate Degree, including the integrated PG degrees, in any branch of Life Sciences with five (5) years’ post qualification experience in clinical trial monitoring. OR 
• PhD in any branch of Life Sciences with two (2) years post qualification experience in clinical trial monitoring. 

Desirable qualifications and work experience: 
• Experience of clinical trial or public health project management in a recognised organisation/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company). 
• Demonstrable experience of line management, project management concepts, and ability to understand, explain and communicate project concepts using standard tools and templates 

Job profile The Project Manager (Monitoring) will be responsible for ensuring the quality, integrity, and compliance of assigned clinical research studies through robust monitoring and oversight activities. The role focuses on clinical site monitoring, quality assurance, risk-based oversight, and capacity building, while working in close coordination with the central study, regulatory, and project management. 

Key Responsibilities: Clinical Monitoring & Oversight 
• Conduct site qualification, initiation, routine monitoring, and close-out visits for assigned clinical research studies in accordance with approved monitoring plans. 
• Perform both onsite and remote monitoring to ensure subject safety, protocol adherence, data accuracy, and documentation completeness. 
• Review source documents, CRFs, informed consent forms, and essential documents to ensure compliance with protocol, GCP, and applicable regulations. 
• Identify, document, and follow up on protocol deviations, non-compliance issues, and data discrepancies. • Ensure timely preparation and submission of monitoring visit reports and follow-up letters. Quality Assurance & Compliance 
• Support implementation and maintenance of quality management systems related to clinical monitoring and study oversight. 
• Ensure adherence to ICH-GCP, Indian regulatory requirements, ethics committee approvals, and institutional SOPs during study conduct.
• Support audit and inspection readiness, including participation in audits and follow-up on assigned Corrective and Preventive Actions (CAPAs). 
• Contribute to the development and periodic review of monitoring plans, SOPs, checklists, and quality tools. Risk-Based Monitoring 
• Support the development and implementation of risk-based monitoring strategies. 
• Proactively identify study and site-level risks related to data quality, participant safety, or compliance. 
• Escalate critical issues to the study leadership and Quality/CPM teams in a timely and documented manner. Training & Capacity Building 
• Deliver GCP, GDocP and monitoring-related training to site staff and study teams as required. 
• Provide ongoing guidance and mentoring to site personnel to improve compliance, documentation quality, and operational performance. 
• Serve as a trainer for clinical research and monitoring-related training initiatives conducted by CDSA, as assigned. Coordination & Reporting 
• Work closely with the central study team, data management team, and Quality/CPM leadership to ensure effective study oversight. 
• Participate in internal study review meetings to provide updates on monitoring findings, site performance, and quality trends. 
• Maintain accurate and inspection-ready documentation of all monitoring and quality oversight activities. 

Travel Requirement 
• Must be willing to travel extensively to clinical sites across India, including short-notice travel and extended site visits when required. 

Skills 
• Strong understanding of clinical trial monitoring, GCP, and human subject protection. 
• Demonstrated ability to independently manage assigned monitoring responsibilities with minimal supervision. 
• Strong observational, analytical, and problem-solving skills. 
• Excellent written and verbal communication skills in English. 
• Ability to prepare clear and concise monitoring reports, quality summaries, and follow-up documentation. 
• Proficient in MS Word, Excel, PowerPoint, and electronic clinical trial systems (EDC, CTMS, eTMF – as applicable). 
• Professional judgment, integrity, and the ability to build trust with investigators and site teams. 
• Ability to work collaboratively within multidisciplinary research teams. 

3. Name of the post Clinical Research Associate 

Number of the post 02 

Name of the Project Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment (ATT) and macronutrient supplementation on body weight, nutritional outcomes, and quality of life in adults with newly diagnosed drug-sensitive NAAT-positive Pulmonary Tuberculosis: An open-label randomized controlled parallel-arm clinical study 

Emoluments Rs. 67,000/- + HRA 

Age 40 years

Minimum Educational Qualification and Experience 
• Master’s degree in any branch of life sciences or pharmacy or public health or health related discipline with minimum three (3) years of relevant clinical trial monitoring experience. 
• MBBS/ BDS/ BHMS/ BAMS/ BPT with relevant clinical trial monitoring experience. 

Job profile 
• The Clinical Research Associate (CRA) is responsible for overseeing clinical trial sites from initiation to closeout, ensuring compliance with study protocols, ICH-GCP, applicable regulations, and internal SOPs. 

Responsibilities include: 
• Conduct site monitoring visits from initiation through closeout, ensuring trials are conducted in compliance with the study protocol, GCP guidelines, SOPs, and applicable regulatory requirements. 
• Set up trial sites, ensuring that investigational products and essential trial supplies are delivered, stored, and documented appropriately. 
• Perform quality checks and execute quality assurance process across clinical operations and clinical laboratories in accordance with GCP/GCLP standards. 
• Provide training on protocols and trial procedures to site staff and maintain ongoing communication to support study execution and address issues. 
• Support clinical staff through guidance and training as and when needed. 
• Create, maintain, and submit all required documentation related to site management, monitoring visits, findings, and follow-up actions. 
• Track and manage study progress, including regulatory and ethics submissions, patient recruitment and enrolment, CRF completion, and data query resolution. 
• Verify data accuracy through source data/document verification to ensure consistency between CRFs and clinical records. 
• Prepare detailed monitoring visit reports and contribute to the preparation and archiving of essential trial documents. 
• Assess trial site compliance and escalate quality or protocol deviations to the Project Manager, or Senior Leadership as appropriate. 
• Collaborate with Clinical Portfolio Management and other internal departments on cross-functional initiatives and project requirements 
• Collaborate cross-functionally with clinical operations, data management, safety, and regulatory teams. • Maintain effective communication with investigators and site staff to ensure study success. 
• Frequently travel to assigned trial/study sites by eligible modes of travel, including city and state public transportation, own transportation, train travel, or private mass transport services, including standard and luxury buses. 

Skills 
• Proficient in computer applications, with demonstrated expertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). • Strong knowledge of ICH-GCP, GCLP, and regulatory guidelines. 
• Excellent documentation, communication, and organizational skills. 
• Ability to travel frequently to assigned trial sites. 
• Detail-oriented with effective time management skills and ability to manage multiple tasks and priorities efficiently. 

4. Name of the post Senior Project Associate

Name of the Project Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment (ATT) and macronutrient supplementation on body weight, nutritional outcomes, and quality of life in adults with newly diagnosed drug-sensitive NAAT-positive Pulmonary Tuberculosis: An open-label randomized controlled parallel-arm clinical study

Emoluments Rs. 56,000/- + HRA 

Age 35 years

Minimum Educational Qualification and Experience 
• Post Graduate Degree, including the integrated PG degrees, in any branch of Life Sciences. AND 
• Good Clinical Practice (GCP) certification is mandatory. 

Job Profile 

• The Senior Project Associate conducts monitoring visits for the 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.
• 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. 
• Effective time management skills and ability to manage competing priorities. 

Skills 
• Strong understanding of ICH-GCP guidelines and clinical trial lifecycle. 
• Experience working with electronic Trial Master File (eTMF), Clinical Trial Management Systems (CTMS), and document management platforms. 
• Excellent communication, organizational, and problem-solving skills. 
• Detail-oriented with the ability to manage multiple tasks and prioritize effectively. 
• Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook). 

Last date for receipt of online application for posts: 01 June 2026. 

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