Clinical Development Services Agency - An extramural unit of THSTI invites for the post of Clinical Research Associate
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.
The early focus of the CDSA mandate is to promote the enhancement of clinical trial capacity in India as per international standards. This would involve (a) developing Centres of Excellence (COE) in clinical research through partnerships with leading institutions conducting clinical trials in India (b) providing comprehensive and sustained training in clinical research through these COE in order to build a cadre of world class investigators capable of conducting clinical trials for regulatory submissions.
Position: Clinical Research Associate (CRA)
Emoluments: Up to Rs 50,000/- per month consolidated
To monitor clinical trials for projects related to severe acute malnutrition in pediatric population at various trial centers in India.
- Monitoring of clinical studies including study initiation, adverse event reporting, food accountability, source data verification, compliance with protocol and study closure.
- Review documents required at the investigator site as per GCP guidelines.
- Track recruitment rates of patients and flow of clinical data at various investigational sites.
- Ensure data have been transcribed into CRFs in an accurate and timely manner.
- Interface with the Principal Investigator / Co-Investigator for resolution of queries.
The Educational Qualifications:
The candidate must have a basic degree in Medicine, Nursing/ Pharmacy / Biological sciences with certified training in GCP/GLP.
2-3 years of demonstrated experience in monitoring Phase II-III clinical trials. Candidates with a back-ground of nutrition and/or experience in pediatric or epidemiological studies will be preferred.
The position is based in Gurgaon but candidates must be prepared for significant travel for trial monitoring activities to different parts of the country.
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