Clinical Research Associate

3 days ago

India Sun Pharmaceutical Industries - Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year


Job location: Chennai 

YOUR TASKS AND RESPONSIBILITIES:
  • Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
  • Preparation and submission of study documents for EC permission for respective study across centers
  • Oversee & document IP dispensing, inventory management & reconciliation
  • Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
  • Investigator and site personnel training on the Study protocol, procedures, and GCP principles
  • Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
  • Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
  • Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
  • Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL


WHO YOU ARE:
  • Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
  • Relevant experience of 1-5 years minimum in the field of Clinical Research
 

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