Operations

• Performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities
• Communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of project files
• Handles project correspondence
• Participates in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Attends meetings and prepares accurate meeting minutes and action items
• Anticipates, identifies and resolves potential issues and implements corrective actions
• Completes all necessary and assigned training
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS)

Senior Clinical Operations Specialist – FSP

EMEA Operations Specialist

Clin Ops Specialist – FSP