Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Clinical Research Associate II
(An Open-label, non-randomized Two-stage, Dose Finding study of Verapamil tablet formulation in Adult TB patients in Continuation Phase)
Consolidated salary per month : Up to Rs. 60,000/-
Duration : The study duration is two years. The initial appointment will be for a period of one year to be continued subject to performance.
Age : Up to 45 years
The Study Monitor/ Clinical Research Associate conducts monitoring visits for assigned study protocol and study sites. Overall responsibilities are to oversee the progress of assigned clinical study to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Key responsibilities for CRA include following;
• Performs site preparedness / start -up, site initiation and site monitoring (throughout the trial which involves visiting the trial sites on a regular basis) and close-out visits in accordance with contracted scope of work
• Performs quality functions and execute quality programs (clinical operations, clinical laboratory) to ensure compliance with protocol, SOPs, Good Clinical Practices guidelines and applicable regulations.
• Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
• Ensures that each study site has the adequate clinical trial supplies and equipment (including the investigational product, as applicable) and ensure 100% accountability of the same.
• Administers / facilitate protocol and other related study 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 study 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.
• Perform source data review and source data verification (to ensure that data entered on to the CRFs is consistent with patient clinical notes / source documents
• Writing site visit reports and follow-up letters within the timelines as per the SOPs / project requirement.
• Filing and collating trial documentation and reports.
• Archiving study documentation and correspondence
• Evaluates the quality and integrity of study 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
• Bachelor’s in medical sciences or Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred
• Minimum 3 years of relevant clinical trial/ study monitoring experience
• 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
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GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification should be from a recognized Board/ University and full-time.
2. The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
3. Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
4. The qualification, experience and other requirements for the post can be relaxed at the discretion of the Chairman of the Interview Committee, in case candidates are otherwise well qualified.
5. Only shortlisted candidates will be contacted for interview
6. Incomplete applications will stand summarily rejected without assigning any reasons.
7. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is the maximum and can be lesser based on candidate’s experience, qualifications, skill set, etc.
8. This position is strictly project-based.
9. All results will be published on our website and all future communications will be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement for attending the interview.
11. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
12. Canvassing in any form will be a disqualification.
Procedure for filling online application:
a. Before filling up the online application, keep the following documents handy:
i) A soft copy of your passport size photo and signature. (only jpeg/jpg format, file size 50 kb maximum)
ii) A comprehensive CV (PDF format only, file size 1 mb maximum) containing details of qualification, positions held, professional experience/distinctions etc.
iii) The documents in support of educational qualification and experience (PDF format only, file size 1 mb maximum) as mentioned below:
• Matriculation Mark sheet
• Intermediate Mark sheet
• Graduation Degree/Mark Sheet
• Post-Graduation Degree/Mark Sheet
• Ph.D degree
• Relevant experience certificates
• Caste certificate in the format prescribed by the Govt. of India, if applicable
• Disability certificate in the format prescribed by the Govt. of India, if applicable
• List of Publications (if any)
• List of patents (if any
b. Candidates are requested to use Google Chrome internet browser for best results in submission of online application.
c. Once online application is submitted, no correction/ modification is possible.
d. In case of difficulty in filling up the online form, please send an e-mail to firstname.lastname@example.org
e. On successful submission of your application, a pop up window will appear showing the reference number. Please keep a note of the reference number for future correspondence.
Last date for receipt of online application is October 2, 2019
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