Project Coordinator

Roles and Responsibilities include:

·         *Provide support to the Project Management Department and assistance to Project Manager(s) in completion of all required tasks to meet departmental and project goals.
·         Support the cross-functional teams regarding development and maintenance of the trial master file and study specific documentation.
·         *Set up, organize, track and maintain clinical study and project documentation both hardcopy and electronic (e.g. Main Study Files, CRFs, etc.) including document receipt and review, scanning and indexing, quality control, copying, filing,  preparation for internal/external audits, final reconciliation and archival.
·         *Assist in quality control audits of clinical study and project documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.)
·         Assist with Investigative site and vendor contract execution, if required.
·         Assist with submissions to the Independent Ethics Committee and Hospital Ethics Committees, if required.
·         Review deliverables prepared by team before passing to client, as required.
·         Effectively apply IDS project management methodology and enforce project standards as appropriate.
·         Ensure project documents are complete, current, and stored appropriately.
·         *Plan and coordinate limited service, stand alone projects, as assigned, in accordance with the contract and in adherence with ICON SOPs, ICH GCP and appropriate regulations.
·         Create, execute, maintain a detailed project plan in accordance with the approved scope of work and revise as appropriate to meet changing needs and requirements.
·         Coordinate day-to-day operational aspects of a project and scope.
·         Track, report and approve team hours and expenses on a weekly basis as applicable.
·         Manage project budget to ensure financial targets are met through regular review of direct/indirect costs and project resources for assigned projects. 
·         Determine appropriate revenue recognition, ensure timely and accurate invoicing, and monitor receivables for assigned projects. 
·         Collaborate with Finance and Project Analysis to ensure accurate revenue recognition, invoicing, and other financial reconciliation activities for assigned projects.
·         Recognize and submit out of scope requests for costing and approval for assigned projects.
·         Prepare management reports and serve as management’s source for project updates on milestones, project schedule and key project issues and metrics for assigned projects. 
·         Facilitate effective communication among all project-related parties.  
·         Coordinate roles and responsibilities within the project team, ensuring that each team member understands requirements for project deliverables as outlined within the scope of work.