Walk-In Interview as a Clinical Research Associate at BRIC – Translational Health Science and Technology Institute (THSTI) – 19th March 2024

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Welcome to an unparalleled opportunity to join the esteemed BRIC – Translational Health Science and Technology Institute (THSTI), an autonomous institution under the Department of Biotechnology, Ministry of Science and Technology, Government of India. Situated within the vibrant NCR Biotech Science Cluster in Faridabad, we are at the forefront of cutting-edge research and innovation in healthcare.

We are excited to announce openings for a Clinical Research Associate (01) and a Quality Manager (01), offering individuals a chance to contribute to transformative healthcare advancements. As part of our interdisciplinary team, you’ll play a pivotal role in driving research initiatives that have the potential to impact lives globally.

Skills Computer skills including proficiency in use of Microsoft Office applications
1. Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
2. Strong written and verbal communication skills including good command of English required.
3. Excellent organizational and problem-solving skills.
4. Effective time management skills and ability to manage competing priorities.

Job profile
The Study Monitor/ CRA 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.
1. 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.
2. Performs quality functions and executing quality programs (clinical operations, clinical laboratory) as per GCP/GCLP and regulations.
3. Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
4. 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.
5. Administers protocol and related trial training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
6. May provide training and assistance to junior clinical staff.
7. Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required trial documentation.
8. 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.
9. Verifying that data entered on to the CRFs is consistent with participant clinical notes (source data/ document verification)
10. Writing visit reports.
11. Filing and collating trial documentation and reports.
12. Archiving trial documentation and correspondence.
13. Evaluates the quality and integrity of trial site practices related to the proper conduct of the protocol and adherence to applicable regulations.
14. Escalates quality issues to the Quality Manager, Project Manager and/ or senior management.
15. Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required.

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GENERAL TERMS & CONDITIONS: –
a) This is 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.
d) 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. In case candidates are not found suitable for the posts notified, they can be offered lower post / lower emoluments on the recommendation of the Selection Committee.
e) 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
1. 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. There is no upper age limit for the Institute employees who are treated as departmental candidates. 6. For Ex-servicemen up to the extent of service rendered in defense forces (Army, Navy & Air force) plus3 years provided they have put in a minimum of 6 months attested service.
f) All results will be published on our website and all future communications will be only through email.
g) 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.
h) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules / guidelines shall prevail.
i) Canvassing in any form will be a disqualification.
j) You are requested to bring 2 passport size photograph & one set of photocopies of your education/qualification certificate/documents along with the originals at the time of interview.

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