THSTI Pharma Clinical Research Associate Vacancy Announced
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
the 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 the development of an eco-system for training and learning and works with public sector institutions and small and medium enterprises (SME) to translate innovative technologies into medical products for the public good.
The main objectives of CDSA are:
a) As an academic Clinical Research Unit, to undertake & provide end-to-end
clinical study support for investigators and SMEs in study planning, set up,
conduct: project management, monitoring, data management, safety reporting,
analysis and report writing
b) Build research capacity and capability through high-quality training in the area
of clinical development/trials and regulation
c) Support and strengthen clinical research environment in the country
d) Regulatory science and policy support: provide tools and approaches to support
researchers, regulators, health
Job Title: Clinical Research Associate
Number of posts Five
Salary: Up to Rs 65,000/-
Age 35 years
Minimum Educational Qualification and Experience
• Bachelor’s in medical sciences or Master’s degree/ diploma, pharmacy, public health, healthcare or another related discipline
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred
• At least 3 years of relevant clinical trial monitoring experience
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 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 centre 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.
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 to compete for priorities.
General Terms & Conditions:
a) These are short-term positions (period of 03 months to 01 years) and the 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 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 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.
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, the 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.
HOW TO APPLY:
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) Ph.D./MD Degree (if applicable)
viii) Relevant experience certificates (if applicable)
ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if
applicable
Procedure for filling up online application:
i) The eligible and interested candidates may apply online at the Institute’s website
www.thsti.res.in/career. Applications through any other mode will not be
accepted.
ii) The following will be the stepwise 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.
 Last date for receipt of online application: 10th March 2022
The applications will be scrutinized/shortlisted and processed for further selection.
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