Study Setup and Planning: Support the Project Manager by attending meetings, preparing minutes and action logs, preparing protocol-specific laboratory instructions documents. Under supervision of the Project Manager oversee setup of protocol specific Laboratory Centralized Monitoring requirements
Study Activity Monitoring and Closeout: Perform routine tasks across assigned studies including site loading, Investigator Portal access, kit shipments, monitoring day-to-day study performance, overseeing Laboratory Centralized Monitoring. Work with internal and external teams to manage timely resolution of queries and protocol questions, issues and escalations Use status reports, monitoring tools and outputs to pro-actively identify trends and provide feedback to internal and external teams on performance of Investigator sites and company services. Support the Project Manager with administrative study tasks Coordinate and communicate with relevant stakeholders, including leading Customer communications and activities during any times when the Project Manager is absent. Oversee Project Close-out Meetings, Initiatives and Training Activities: May represent company at internal and external meetings, participate in external and internal audits/inspections. As required will support study training with sites, CRAs and customers Ensure outputs are delivered in line with organizational standards, protocol specific requirements and Customer expectations