1.0 - 5.0 years

0 Lacs

bhubaneswar

On-site

As a Clinical Research Associate based in Bhubaneshwar, your primary responsibilities will include performing site feasibility assessments, identifying potential investigators, negotiating study budgets, finalizing investigators and sites, and executing CDA and study-related contracts. You will also be responsible for preparing and submitting study documents for EC permission across centers, overseeing IP dispensing, managing inventory, and conducting reconciliations. In addition, you will play a key role in ensuring timely site initiation, monitoring, and close-out activities, as well as overseeing investigator and site personnel training on study protocols, procedures, and GCP principles. Your duties will also involve facilitating the recruitment of trial participants, ensuring efficient data entry, source data verification, and query resolution, and reporting SAEs and SUSARs in compliance with regulations and Suns PV policies. Furthermore, you will be responsible for identifying risks, conducting analysis, and implementing CAPA for sites that do not meet expectations. Collaborating with in-house or CRO partners for data management, statistical analysis, and report generation will also be part of your role. To qualify for this position, you must have a Bachelor's or Master's degree in a health-related field such as Biology, Chemistry, Nursing, Pharmacy, or Public Health. A Post-graduate Diploma in Clinical Research would also be beneficial. Additionally, a minimum of 1-5 years of relevant experience in Clinical Research is required to be successful in this role.,

Posted 3 days ago

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