The Translational Health Science and Technology Institute (THSTI) is an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Govt. of India.
The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad and is designed as a dynamic, interactive organization 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.
Post: Clinical Research Associate/Study Monitor
Project: GARBH-Ini/POD
Emoluments : Rs. 52,080/- (1 position) & Rs. 55,000/- (2 positions)
Age: 30 years
Experience and Minimum Educational Qualifications
MBBS/BDS/BHMS/BAMS/BPT/ Bachelor’s in medical sciences or Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare, or another related discipline At least 2 years of relevant clinical research experience
Skills: –
• Computer skills including proficiency in the 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.
Job profile
The Study Monitor/ CRA conducts 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 the contracted scope of work.
• Performs quality functions and executes 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 onto 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.
General Terms and Conditions: –
a) These are short-term positions and extensions that 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. d) Closing date of the online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification, etc.
e) The age limit, qualification, experience, and other requirements may be relaxed at the discretion of the competent authority, in the case of candidates who are otherwise suitable.
In case candidates are not found suitable for the posts notified, they can be offered lower posts / lower emoluments on the recommendation of the Selection Committee.
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. 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) plus 3 years provided they have put in a minimum of 6 months attested service.
g) All results will be published on our website and all future communications will be only through email.
h) In case a large number of applications are received, screening will be done to limit the number of candidates to those possessing higher/relevant qualifications and experience.
i) With regard to any provisions not covered in this notification, the bye-laws of THSTI / Govt. of India rules/guidelines shall prevail.
j) Canvassing in any form will be a disqualification.
Interested candidates fulfilling the criteria mentioned above may walk in for a written test/skill test/interview on September 23rd, 2022 at 10:30 am at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad-121001.
