Centralized Study Coordinator

Job description

- **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. - Prepare CRA Prep Packs and send it to CRA’s before the site visit and liase with CRAs and Clinical team to resolve all outstanding queries and issues - 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. - A ssists 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 .