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 : STUDY MONITOR (PTB)
Emoluments : (Upto Rs.40,000 per month, consolidated) Project-based position on contractual basis for 12 months.
Qualifications and Experience
Bachelor's degree in healthcare or other related discipline or equivalent combination of education, training and experience or diploma/post graduate degree in Clinical Research with at least 2 years of relevant experience.
Skills/Desirables
- Basic knowledge of applicable clinical research regulatory requirements; i.e., Indian-GCP, Schedule-Y and ICH-GCP guidelines
- Effective communication skills
- Good computer skills (MS Word, Excel, e-mail, etc)
Job profile
• Perform site initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
• Administer protocol and study-related training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Project Manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other study-related documentation.
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
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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 controlling authority, in case candidates are otherwise well qualified.
5. Interested candidates may please submit the following documents through e-mail with subject line Application for the post of “Study Monitor – PTB Project” to cdsa_admin@thsti.res.in.:
- Cover letter indicating their motivation for the position applied for (150 words)
- Format of application for CDSA positions
- Updated CV (Self-attested)
6. Only shortlisted candidates will be contacted for further discussion
7. Incomplete applications will stand summarily rejected without assigning any reasons.
8. The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
9. This position is strictly project-based.
10. All results will be published on our website and all future communications will be only through email
11. Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
12. This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
13. Canvassing in any form will be a disqualification. Those who have applied earlier need not apply again.
Note: In case a suitable candidate is not found, the call for application will remain open till suitable candidate is found. As soon as suitable candidate is found, this recruitment notice will be closed on our website.
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