ट्रांसलेशनल हेल्थ साइंस एंड टेक्नोलॉजी इंस्टिट्यूट
Name of the post
Clinical Research Associate
Number of posts
Minimum Educational Qualification and Experience
- Bachelors in Life Sciences with minimum three years of relevant clinical trial monitoring experience.
- 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
- 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.
- 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.
- 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.
- 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.
Last date of receipt of online application:
13th June 2023
How to Apply:
- Documents to be kept handy before filling up the online application: (all the documents except (i) should be in pdf format)
- A soft copy of your passport size photo and signature. (jpeg/jpg/png format)
- A comprehensive CV containing details of qualification, positions held, professional experience / distinctions etc.
- Matriculation certificate (equivalent to 10th Standard) / Mark sheet
- Intermediate certificate (equivalent to 12th Standard) / Mark sheet
- Graduation/Diploma degree certificate / Mark sheet
- Post-Graduation degree certificate & Mark sheet (if applicable)
- PhD/MD Degree (if applicable)
- Relevant experience certificates (if applicable)
- Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable.
- Forwarding letter / NOC from the current employer in the case of candidates working in Govt. / PSUs / autonomous bodies.
- Submission of the application will be through online mode only. Otherwise, it will get rejected or ignored.
General Terms & Conditions:
- This is a short-term position (01 year) 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.
- All educational, professional and technical qualifications should be from a recognized Board/University.
- The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post.
- Closing date of online application will be the CRUCIAL DATE for determining eligibility with regard to age, essential qualification, etc.
- The number of positions to be hired, 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 a lower post / lower emoluments on the recommendation of the Selection Committee.
- Age and other relaxations for direct recruits and departmental candidates:
- By five years for candidates belonging to SC/ST communities.
- By three years for candidates belonging to OBC communities.
- For Persons with Benchmark Disabilities (PWBD) falling under the following categories:
- UR – ten years
- OBC – 13 years
- SC/ST – 15 years
- 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.
- There is no upper age limit for the Institute employees who are treated as departmental candidates.
- All results will be published on our website and all future communications will be only through email.
- 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.
- With regard to any provisions not covered in this notification, the bye-laws of THSTI / Govt. of India rules / guidelines shall prevail.
- Canvassing wrong in any form will be a disqualification.
- The candidate may be transferred to site location as per the project requirement and management discretion.
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About Translational Health Science And Technology Institute (THSTI) – ट्रांसलेशनल हेल्थ साइंस एंड टेक्नोलॉजी इंस्टिट्यूट:
THSTI has unique foundational elements to support its mission. With enthusiastic, well-trained interdisciplinary young faculty who have a spectrum of scientific strengths that bridges clinical, basic and applied sciences; their commitment to fo
cus on practical science and technology and the building and strengthening of academia-industry networking promote an institutional architecture and environment to support translation. The strong clinical links and collaboration and the support of clinical development feasible through CDSA distinguish THSTI among all DBT institutions.
As an autonomous institute of DBT established with the mandate of finding solutions for large and unique public health problems, we exist to serve society through science. Therefore, we take on problems that may be complex and large but where our inter-disciplinary skills are necessary for solutions. Altruism, ambition and accountability define the future of THSTI, and we look forward to working with partners towards our mandate of creating an environment that enables innovation and drives the translation of research into clinical settings and commercial enterprises as services and products that will improve public health in India.
Contact Us: Translational Health Science and Technology Institute
NCR Biotech Science Cluster, 3rd Milestone, Faridabad – Gurgaon Expressway, PO box #04, Faridabad – 121001 (HARYANA)
Webside Address: https://thsti.res.in/newthsti/
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