Senior Centralized Study Coordinator

**Summary of Responsibilities:** * Follow all applicable departmental Standard Operating Procedures and Work Instructions. * Complete day-to-day tasks ensuring quality and productivity. * Track and report metrics as determined by management according to required timelines. * Participate in process improvement opportunities and assist with the implementation of revised processes and procedures. * Other duties/activities as assigned by study management team, but not limited to: * Manage clinical systems & access management * Manage study documents such as study level, country level and site level * Maintain study databases (CTMS, IWRS, EDC etc.) * Support study team in e-TMF management activities * Support study team in data review and support activities. * Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support. * Address all outstanding issues for sites and provide a snapshot of issues to Clinical team including CRA’s to make the site visits more effective and efficient. * Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable. * Actively support compliance metrics including TMF, CTMS, and overall project health. * Update timelines and milestones within project scheduling tools, CTMS, project governance tool, and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk. * Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations. * Draft or assist Functional Leads with project plans and coordinating review, feedback, and execution between study team and client. * Work with Study Team to maintain WISER moments. * May assist with additional cross-functional tasks according to project needs. * Initiates RIM changes, manages PCC Log, and supports documentation and impact tracking. * Assists in vendor management activities including invoice tracker and PO requisitions. * Handles PII assessments, system documentation, and updates to XRIM as needed Additional responsibilities (Centralized study team may perform below activities): * Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed. * Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements. * Vendor Management oversight. Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).