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:
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.
