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 : Research Officer (iKMC Study), 01 Position
Age Limit Upto 40 Years
Emoluments/ Duration : Rs. 75,000/- per month consolidated, 30 Months
Location : NCR Biotech Science Cluster, Faridabad
Job profile
- Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
- Advising and providing training to research team on interpretation of GCP/ethical requirements on biomedical research for quality management.
- Overseeing and/or performing quality functions and executing quality programs (clinical operations, data collection, management and transmittal)
- Developing quality management plan and ensuring compliance
- Setting up documentation standards and ensure compliance throughout the study span
- Identifying areas of deficiency and trends in quality and escalating to appropriate personnel
- Collaborate with clinical and project coordination team to ensure compliance with quality standards, timelines and appropriate followup in areas of deficiency
- Coordinate expert monitoring visit/ audits as per project requirement.
- Educating, training, and mentoring research team in quality improvement methods
- Supervise quality management team to ensure efficient monitoring of all the study components, reporting and follow-up for corrective and preventive action.
- Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
Qualifications and Experience
Medical or allied bachelor’s degree or Masters in life sciences/ pharmacy/ healthcare or other related discipline. At least 5 years of demonstrated experience in the area of Management, Quality Assurance and/or Clinical operations of clinical trials / research projects. GCP trained and experience of handling field based studies will be preferred.
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Skills
- Good understanding of needs for project and job responsibilities.
- Extensive knowledge of GCP/GLP, public health studies and appropriate regulations and guidelines.
- Ability to develop and implement clinical monitoring plans, SOPs, database concepts, and formats
- Ability to build effective project teams, ability to motivate others, delegation, drive and timely/ quality decision making
- Operational skills including focus and commitment to quality management and problem solving
- Influencing skills including negotiation and teamwork.
- Effective communication skills to provide timely and accurate information to stakeholders
- Ability to assess non-compliance situations and recognize potential or real wider strategic risk to project, escalates when needed.
- Ability to identify systematic causes of complex quality problems and recommend long-term solutions
- Fair and ethical. Creates a culture that fosters high standard of ethics.
- Basic business computer skills (MS Word, Excel, e-mail)
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 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 “Research Officer (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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