Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an autonomous organisation and extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.
Post : Clinical Research Associate
Age Limit : Upto 40 Years
Emoluments/ Duration : Upto Rs. 45,000/- per month consolidated, 24 Months
Location : Safdarjung Hospital, Delhi
Job profile
Overall responsibilities are to ensure that the study is conducted in accordance with study protocol, standard operating procedures, good clinical practices, and applicable guidelines.
• Performs site monitoring activities in accordance with contracted scope of work
• Completes induction program including appropriate therapeutic, protocol and clinical research trainings to perform job duties.
• Acts as communication channel while facilitating effective communication among investigators, CDSA and key stakeholders
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Verifying that data entered on to the CRFs is consistent with patient clinical notes (source data/ document verification)
• Conduct process monitoring of the assigned study
• Manages the progress of assigned studies by tracking EC submissions and approvals, subject enrolment, protocol compliance, clinical data collection including CRF completion, and data query generation and resolution.
• Archiving study documentation and correspondence
• Ensure that study is conducted, recorded and reported as per protocol, guidelines and applicable regulations & help ensure quality and integrity of clinical data.
• Escalates quality issues to the project coordinator /senior management and work with study team for implementation of action plan for resolution of issues.
• Work closely with Clinical Portfolio Management department and/or other internal departments as and when required
Qualifications and Experience
• Medical /Allied bachelor’s degree or Master’s degree in life sciences/pharmacy/healthcare or other related discipline or diploma/ post graduate degree in Clinical Research
• 2-3 years of clinical operations /monitoring /site coordination experience in clinical trials / research projects
Skills
• Excellent reading comprehension and strong written as well as verbal communication skills including good command of English required
• Computer skills including proficiency in use of Microsoft Office applications
• Good knowledge and ability to apply GCP and applicable regulatory guidelines
• Good organizational behavior and problem solving skills
• Effective time management skills and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with co-workers, managers, investigators
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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 posts are relaxable at the discretion of the competent authority, in case of candidates who are otherwise suitable. Candidates not found suitable for the posts notified, can be offered a lower post on the recommendation of the Selection Committee.
5. No TA/DA will be admissible to appear in the interview, including (SC/ST candidates).
6. Preferably female candidates, who can join immediately needs to apply, as the position is to be filled on an urgent basis.
7. This position will be purely on temporary/contractual basis for the specified period of time and based on project.
8. In case large number of applications are received for each post, screening will be done to limit the number of candidates to those possessing higher/relevant qualification.
9. Only shortlisted candidates will be called for Written test/Interview. Request for change in Written test/ Interview schedule will not be entertained under any circumstances.
10. The salary is a consolidated sum without any other benefits and it is based on experience, qualifications, skill set, etc. of the candidates.
11. Interested candidates may please send their current CV along with the application form (attached on CDSA website) with a recent color photo and cover letter indicating their motivation for the position applied for in 150 words and three references by e-mail with subject line mentioning “Application for the position “Clinical Research Associate (iKMC Study)” to cdsa_admin@thsti.res.in.
12. Incomplete applications will stand summarily rejected without assigning any reasons thereof.
13. All results will be published on our website and all future communications will be only through email.
14. Canvassing in any form will be a disqualification.
Applications will be accepted up to 8th January 2018.
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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