Opportunity for B.Pharm, Pharm.D as Research Scientist at CDSA - Salary Rs. 67,000 + HRA pm

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 : Project Research Scientist - I (Medical)

Number of the post : One (01)
Name of the Project : Early Intervention with Low Molecular Weight Herparin (Enoxaparin) for Prevention of Moderate to Severe Acute Pancreatitis : A Double-Blind Placebo Controlled Investigator Initiated Multicenter Randomised Trial

Emoluments : Rs. 67,000/- + HRA
Age : 40 years
Essential qualifications and work experience : • MBBS, BDS, BVSc, BAMS, BHMS, BUMS, BSMS, BNYS, B.Sc. Nursing, BPT, B.Pharm, Pharm.D or equivalent with two years post-qualification experience in clinical project management and/or clinical trial/ study monitoring in a recognised organisation/institute (hospital, academic clinical trials unit, CRO, pharmaceutical, or medical device company)

Job profile
Project Research Scientist - I (Medical) 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.
• Maintain effective communication with investigators and site staff to ensure study success.
• Frequently travel to assigned trial/study sites by eligible modes of travel.
• Work in collaboration with Clinical Portfolio Management on assigned projects, and provide support to other internal departments in fulfilling their requirements, as and when necessary.

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.

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
2. 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/-
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 HR.CDSA@THSTI.RES.IN along with the screenshot of the error displayed (if any)