Clinical Research Associate

1 - 5 years

0 Lacs

Posted:2 weeks 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 responsibilities will include conducting site feasibility assessments, identifying potential investigators, negotiating study budgets, finalizing investigators and sites, and executing study-related contracts. You will be responsible for preparing and submitting study documents for EC permission, overseeing IP dispensing, managing inventory, and ensuring reconciliation. Additionally, you will play a key role in ensuring timely site initiation, monitoring, and close-out activities, as well as conducting investigator and site personnel training on study protocols, procedures, and GCP principles. Your tasks will involve overseeing trial participant recruitment, data entry, source data verification, and query resolution in an efficient and effective manner. Furthermore, you will be responsible for reporting adverse events, ensuring compliance with regulations and Suns PV policies, identifying risks, analyzing issues, and implementing CAPA for sites that do not meet expectations. You will also collaborate with in-house or CRO partners for data management, statistical analysis, statistical analysis reports, and DBL coordination. To qualify for this role, you should hold a Bachelor's or Master's degree in a health-related field such as Biology, Chemistry, Nursing, Pharmacy, or Public Health, or possess a Post-graduate Diploma in Clinical Research. A minimum of 1-5 years of relevant experience in the field of Clinical Research is required to be successful in this position.,

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