Zydus Therapeutics

Research Analyst

• Responsible for of all aspects of site monitoring activities
• Including the conduct of Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Periodic Monitoring Visits (PMVs) and Close-out Visits (COVs) in accordance with ICH/GCP principles
• Act as the primary contact/ manager for sites to include, but not limited to the following activities
• Provide proper training and guidance to site staff on the protocol and all study related materials
• Ensure appropriate safety monitoring, per ICH/GCP principles, are reviewed on an ongoing basis and ensure site has proper oversight of safety reporting requirements
• Acts as the primary contact to assigned sites to ensure there is proper compliance to the protocol, adherence to patient safety, proper IP management and study supply management
• Review sites recruitment and enrollment activities and assist with recruitment planning and solutions as needed
• Ensure proper review of the sites Investigational Site File Binder and ensure all plans, communications and logs are maintained and updated appropriately as per ICH GCP and GDP requirements
• Will provide support to all functional groups (as needed) to ensure proper reporting of safety data and proper site compliance to all protocol and protocol related materials
• Will perform site oversight to prevent noncompliance, escalate noncompliance issues and provide guidance/ preventative action plan to prevent future noncompliance as needed

Clinical Research Associate