Job Description

Job location: Kolkata
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