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.
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.
Project Scientist -III
Name of the Project : INDIGO Effective and Affordable flu Vaccine for the world
Emoluments : Rs. 78,000/- + HRA
Age : Up to 40 years
Essential qualifications and work experience :
• MBBS/ BDS/ Alliied Medical degree OR
• Ph.D/Master’s degree/ diploma in life sciences, pharmacy, public health, healthcare or other related discipline OR
• A minimum of 2 years’ experience in Clinical Project Management and/or Clinical trial/Study monitoring Post Ph.D or 5 years experience Master’s degree/M.B.B.S/B.D.S
• Experience of clinical trial or public health project management in a recognized organization/institute (academic clinical trials unit, CRO, pharmaceutical, biotechnology, or device company). Desirable qualifications and work experience:
• Postgraduate degree in Public Health
• MD/DNB from a recognized Indian University/ recognized by MCI
• PhD in a health-related discipline
• Demonstrable experience of line management, project management concepts and ability to understand, explain and communicate project concepts using standard tools and templates.
The position is responsible for Responsible for oversight, management and operational execution of assigned clinical studies and trials. Timely delivery of key tasks, while maintaining high quality standards are: -
Key Responsibilities
• The project manager will manage the performance of project team working on projects.
• The management and cross-functional coordination of the project and work closely to develop and maintain the overall project plan and timelines, communicate project expectations to the respective resource/consultant and manage the overall project budget. Support the team in the implementation of systems for resource planning, study / trial administration, implementation, oversight monitoring, quality assurance and documentation and record keeping.
• Establishment of procedures to ensure adherence to trial protocols and administrative requirements
• Develop project specific and protocol specific training or as requested.
• Monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes
• Liaison with Steering Committee and DSMB with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirement
• Work with the Investigators to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding, or timelines
• Development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees
• Manage distribution, collection and tracking of regulatory documentation to ensure compliance with regulatory and project requirements and audit readiness
• Work with data management and other departments to track progress, milestones and the challenges
• Communicate to team members the scope of work, timeline and project goals, technical information or update.
• Provide guidance and operational area training for project team members and staff as required
• Faculty for training projects conducted by CDSA
• Any other assignment with Clinical Portfolio Management team, based on project deliverables or exigencies.
Skills
• Leadership skills that include the ability to build effective project teams, ability to motivate others, delegation, drive and timely/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, action oriented and resilience in a fast- paced and rapidly changing environment
• Comprehensive understanding of Indian Clinical Trials Regulations, ICH and CDSCO Good Clinical Practice
• Business/ Operational skills that include commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Computer literacy in Word, Excel, PowerPoint, Access or other trial management systems
• Ability to develop and deliver presentations, prepare technical reports and contribute effectively in the manuscripts
• Ability to develop and implement monitoring plans and SOPs
• Ability to make evaluative judgments, remain flexible as projects and priorities change
• Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Knowledge of regulations and guidelines pertaining to the conduct of clinical trials/ studies on human subjects.
Consultant – Clinical Research Associate
Name of the Project : Digoxin in patients with rheumatic heart disease – A randomized placebo – controlled Trial
Emoluments : Rs. 60,000/-
Age : 35 years
Essential qualifications and work 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 Clinical Research Associate/ Study Monitor 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
Research Associate (Quality Assurance)
Name of the Project : Sepsis related mortality in neonates in India: A multi-disciplinary, multi-institutional research program for context specific solutions
Emoluments : Rs. 58,280/-
Age : 35 years
Essential qualifications and work 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 (Experience as above)
Job profile
The Research Associate is responsible for the oversight of clinical trial sites to ensure adherence to study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. This position involves conducting regular monitoring visits, supporting site operations, and maintaining data quality and compliance across all phases of the clinical trial lifecycle.
• 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.
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.
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 qualification 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.
Interested candidates fulfilling the criteria as mentioned for Project Scientist Post may walk-in for a written test/skill test/interview on 02nd September 2025 @09:00 AM for Consultant - CRA at THSTI, NCR Biotech Science Cluster,3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
Interested candidates fulfilling the criteria as mentioned For Consultant and Research Associate May walk-in for written test/skill test/interview on 04th September 2025 @09:00 AM at THSTI, NCR Biotech Science Cluster, 3rdMilestone, Faridabad-Gurugram Expressway, Faridabad – 121001.
NOTE
1) The candidates 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.
See All B.Pharm Alerts M.Pharm Alerts Ph.D Alerts Haryana Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
