THSTI Offers Research Opportunities for Life Sciences or Pharmacy Candidates

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.

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

Research Officer
Number of the post : 01
Name of the Project : Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to anti- tuberculosis 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 : • 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 project- specific 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 Research Officer : 25th May 2026 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001

Project Manager (Monitoring)
Number of the post : 01
Name of the Project : Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to anti- tuberculosis 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 : upto 45 years
Minimum Educational Qualification and 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.

Clinical Research Associate
Number of the post : 02
Name of the Project : Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to anti- tuberculosis 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 : upto 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.

Senior Project Associate
Number of the post : 01
Name of the Project : Efficacy. Safety, and Tolerability of Ayurveda regimen as an adjunct to anti- tuberculosis 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 : upto 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.
• 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.
The applications will be scrutinized/shortlisted and processed for further selection.
NOTE : 1) The candidates applying for the Sr. No. 1 post must bring their latest resume, one set of photocopy of documents in support of their educational qualification and experience along with originals and a valid ID cards for verification.
2) Candidates coming after the time slot mentioned will not be entertained.
3) All the candidates coming for written test/skill test/interview will be mandatorily required to deposit their mobile phone along with a valid Identity proof at the reception and the same will only be returned back on completion of the entire selection process.

General Terms & Conditions
a) These are the short-term positions, and extension will be granted subject to satisfactory performance of the incumbents and tenure of the project for which they are selected. Those appointed to these positions will not have any claim for regularization of their employment.
b) All educational, professional and technical qualifications should be from a recognized Board/University.
c) The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post. The candidates are required to satisfy themselves, before applying /appearing for the selection process, that they possess the minimum eligibility criteria as laid down in the recruitment advertisement. No query will be entertained with regard to the eligibility criteria.
d) Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification, experience etc.
e) The age limit, qualification, experience and other requirements may be relaxed at the discretion of the competent authority, in case of candidates who are otherwise suitable.
f) Age and other relaxations for direct recruits and departmental candidates: 1. By five years for candidates belonging to SC/ST communities. 2. By three years for candidates belonging to OBC communities. 3. For Persons with Benchmark Disabilities (PwBD) falling under the following categories : (i) UR - ten years, ii) OBC - 13 years (iii) SC/ST - 15 4. Age is relaxable for Central Government servants up to five years in accordance with the instructions or orders issued by the Central Government, from time-to-time. 5. Institute employees will get the age relaxation to the extent of the service rendered by them as on closing date of advertisement. 6. For Ex-servicemen upto the extent of service rendered in defence forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service.
g) All results/notifications will only be published on our website. Therefore, the candidates should essentially visit THSTI website, regularly.
h) All communications will only be made through email.
i) In case a large number of applications are received, screening will be done to limit the number of candidates to those possessing higher/relevant qualification and experience.
j) The no. of vacancy indicated above may change subjected to the actual requirement at the time of Written test/skill test/interview.
k) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules/ guidelines shall prevail.
l) Canvassing wrong information in any form will be a disqualification.

How to Apply
1. Documents to be kept handy before filling up the online application: (all the documents except (i) should be in pdf format) :
i) A soft copy of your passport size photo and signature. (jpeg/jpg/png format)
ii) A comprehensive CV containing details of qualification, positions held, professional experience / distinctions etc.
iii) Matriculation certificate (equivalent to 10th Standard) / Mark sheet
iv) Intermediate certificate (equivalent to 12th Standard) / Mark sheet
v) Graduation/Diploma degree certificate / Mark sheet
vi) Post-Graduation degree certificate & Mark sheet (if applicable)
vii) PhD degree/certificate (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable

Procedure for filling up online application :
i) The eligible and interested candidates may apply online at the Institute’s website. Applications
through any other mode will not be accepted.
ii) The following will be the step wise procedure-
A) Step 1 : Details of applicant
B) Step 2 : Uploading of documents
C) Step 3 : Payment of application fee
• The payment can be made by using Debit Card / Credit Card / Internet Banking/ UPI.
• Once payment is made, no correction / modification is possible
• Candidates are requested to keep a copy of the provisional receipt for future reference.
• Fee once paid shall not be refunded under any circumstances.
• Details of fees to be paid are as shown below :
1. Unreserved, OBC & EWS candidates Rs. 590/-
2. SC/ST/Women/PwBD Rs 118/-
D) Step 4 : Submission of application form
iii) On successful submission of application, an auto-generated email containing the reference
number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.
iv) Candidates are required to keep a printout of the online application form by using the print button on the dashboard for future reference.
v) Candidates must ensure that he / she fulfils all the eligibility criteria as stipulated in the
advertisement. If it is found that he / she does not fulfil the stipulated criteria during the recruitment process, the candidature of the candidate will be cancelled. If the same is noticed after the appointment, the candidate will be terminated following due process.
vi) Incomplete applications shall be summarily rejected and no correspondence in this regard shall be entertained.
vii) In case of difficulty in filling up the online form, please send e-mail to personnel@thsti.res.in along with the screenshot of the error displayed (if any).