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 (iKMC Study), 01 Position
Age Limit Upto 35 Years
Emoluments/ Duration : Rs. 45,000/- per month consolidated, 30 Months
Location NCR Biotech Science Cluster, Faridabad
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.
1) Performs site monitoring as well as remote monitoring activities in accordance with contracted scope of work / clinical operations plan
2) Completes induction program including appropriate therapeutic, protocol and clinical research trainings to perform job duties.
3) Acts as communication channel while facilitating effective communication among investigators, CDSA and key stakeholders
4) Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
5) Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
6) Verifying that data entered on to the CRFs is consistent with patient clinical notes (source data/ document verification).
7) Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, subject enrolment, protocol compliance, clinical data collection including CRF completion, and data query generation and resolution.
8) Archiving study documentation and correspondence
9) Ensure that study is conducted, recorded and reported as per protocol, guidelines and applicable regulations & help ensure quality and integrity of clinical data.
10) Escalates quality issues to the Quality manager / Trial Coordinator /senior management and work with study team for implementation of action plan for resolution of issues.
11) Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements 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
At least with 3 years of clinical operations /monitoring experience in clinical trials / research projects
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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 prioritie
- Ability to establish and maintain effective working relationships with coworkers, managers, investigators
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. Only 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 15th October 2017.
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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