Senior Clinical Operations Specialist
Current• Works collaboratively with Clinical Monitoring staff on site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines• Creates and assists cross-functionally with maintenance of project files, including project correspondence• Responsible for completing eTMF file audits• Prepares and maintains site manuals, reference tools and other documents • Maintains, updates, and inputs clinical tracking information into databases• Tracks and updates incoming and outgoing clinical and regulatory documents for investigator sites, studies, project team, or client• Manages shared mailbox, processes site requests and routes correspondence appropriately• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes as well as action items• Anticipates, identifies and resolves potential issues - Implements corrective actions, seeking appropriate guidance as needed to resolve more complex problems• Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training• Provides training or mentorship to inexperienced Clinical Operations Specialists
