Clinical Research Associate

1 - 5 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Clinical Research Associate at Sun Pharma Laboratories Ltd in Bhubaneshwar, your primary responsibilities will include: - Performing site feasibility, identifying potential investigators, negotiating study budgets, finalizing investigators and sites, and executing CDA and study-related contracts - Preparing and submitting study documents for EC permission across various centers - Overseeing and documenting IP dispensing, inventory management, and reconciliation - Ensuring timely site initiation, monitoring, and close-out activities, along with generating necessary reports - Providing training to investigators and site personnel on study protocols, procedures, and GCP principles - Facilitating timely recruitment of trial participants, efficient data entry, source data verification, and query resolution - Reporting SAEs and SUSARs in alignment with regulations and Suns PV policies - Identifying risks, analyzing issues, and implementing CAPA for sites not meeting expectations - Coordinating with in-house or CRO partners for data management, statistical analysis, and reporting Qualifications required for this role: - Minimum Bachelor's or Masters degree in a health-related field like Biology, Chemistry, Nursing, Pharmacy, or Public Health - Post-graduate Diploma in Clinical Research - Relevant experience of 1-5 years in the field of Clinical Research Please note that the mentioned company is Sun Pharma Laboratories Ltd, and the job location is Bhubaneshwar. As a Clinical Research Associate at Sun Pharma Laboratories Ltd in Bhubaneshwar, your primary responsibilities will include: - Performing site feasibility, identifying potential investigators, negotiating study budgets, finalizing investigators and sites, and executing CDA and study-related contracts - Preparing and submitting study documents for EC permission across various centers - Overseeing and documenting IP dispensing, inventory management, and reconciliation - Ensuring timely site initiation, monitoring, and close-out activities, along with generating necessary reports - Providing training to investigators and site personnel on study protocols, procedures, and GCP principles - Facilitating timely recruitment of trial participants, efficient data entry, source data verification, and query resolution - Reporting SAEs and SUSARs in alignment with regulations and Suns PV policies - Identifying risks, analyzing issues, and implementing CAPA for sites not meeting expectations - Coordinating with in-house or CRO partners for data management, statistical analysis, and reporting Qualifications required for this role: - Minimum Bachelor's or Masters degree in a health-related field like Biology, Chemistry, Nursing, Pharmacy, or Public Health - Post-graduate Diploma in Clinical Research - Relevant experience of 1-5 years in the field of Clinical Research Please note that the mentioned company is Sun Pharma Laboratories Ltd, and the job location is Bhubaneshwar.

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