Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Clinical Research Associate
• The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company.
• The CRA is responsible for taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing activities of the appointed studies in compliance with local regulations,
• The CRA coordinates with CRM and RTM and communicates to them progress and critical issues that may impair trial progress. In some cases, the CRA may have direct contact with the ITM.
• Efficient and accurate site selection visits (as appropriate including analysis of site logistics, site performance/quality indicators)
• Accountability for patient recruitment strategies, including implementation of mitigation actions
• Has good knowledge of trial product and trial protocol and train site staff in trial procedures, handling of trial product and documents
• Visit trial sites regularly in accordance with the protocol to perform monitoring activities required
• Proactive use of IT Systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team\
• Guide site staff in preventing deviations that will compromise integrity and quality of trial-conduct
• Graduate in Medicine, Science, Pharmacy or other relevant
• ICH GCP trained and if applicable certified
• Additional qualification on clinical research would be preferred
• 2 - 4 years of experience as a CRA
• Experience in 1-2 multinational clinical trials phase 2-3 from site initiation till site closure
Qualification : B.Pharmacy, BSc
Experience : 2 - 4 years
Location : Mumbai, Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical
End Date : 20th September, 2023
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