Clinical Operations

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies
• Communicate with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepare and maintain site manuals, reference tools and other documents
• Maintain, update, and input clinical tracking information into databases
• Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manage shared mailbox, process site requests and route correspondence appropriately
• Coordinate ordering, packaging, shipping and tracking of site supplies and materials
• Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items
• Handle receipt, tracking and disposition of Case Report Forms and Queries when required

Clinical Operations jobs in South Korea

Clinical Operations Specialist