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. 

• 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.  

• 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.