Clinical Research Associate
2 days ago
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
- Minimum qualification requirement is to have a Bachelor's or Master's degree in a health-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
Locations: Not Applicable
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