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.
Post : Senior Clinical Research Associate
Number of the post : 03
Name of the Project : Effect of Immediate Kangaroo Mother Care (iKMC) on neonatal mortality and culture-positive sepsis in low-birth-weight neonates in district hospitals in Chhattisgarh, India: a stepped-wedge cluster randomized trial
Emoluments : Rs. 75,000 per month
Age : 40 years
Minimum Educational Qualification and Experience
• Bachelor's in Life Sciences with a minimum of three years of relevant clinical trial monitoring or clinical trial/study coordinator, or clinical trial/study associate experience. OR
• Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline with a minimum of 2 years of relevant clinical trial monitoring or clinical trial/study coordinator, or clinical trial/study associate experience. OR
• MBBS/ BDS/ BHMS/ BAMS/ BPT with a minimum of 2 years of relevant clinical trial monitoring or clinical trial/study coordinator, or clinical trial/study associate experience.
Job profile
• The Sr. 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 monitoring visits (on-site and remote), including initiation, routine monitoring, and closeout.
• Ensure trial sites comply with regulatory, protocol, and GCP requirements.
• Conduct risk-based monitoring and escalate site issues and protocol deviations appropriately.
• Verify informed consent and subject safety in alignment with ethical standards.
• Monitor AE/SAE reporting timelines to ensure compliance with regulatory requirements and escalate delayed submissions to the pharmacovigilance team.
• Review source documents and CRFs to verify data accuracy and consistency (SDV).
• Ensure appropriate management and documentation of investigational product (IP).
• Maintain essential trial documents in accordance with ICH GCP and local regulations.
• Prepare detailed monitoring visit reports and manage action items.
• Support regulatory and ethics submissions, patient recruitment, and resolution of data queries.
• Provide training to site personnel on study protocols, GCP, and SOPs.
• Ensure timely delivery and proper handling of study supplies and investigational product.
• Monitor quality metrics and assist with CAPA implementation.
• Ensure site readiness for audits and regulatory inspections.
• Use clinical trial systems (EDC, CTMS, eTMF) for tracking, documentation, and communication.
• 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.
• 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
Walk in Interview
Date : 02nd December 2025 @09:00 AM
Time : 09:00 AM
Venue : THSTI, NCR Biotech Science Cluster, 3rd Milestone,
Faridabad-Gurugram Expressway, Faridabad – 121001.
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