Clinical Project Coordinator

Job Summary: The Clinical Project Coordinator position is responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets and quality standards are being achieved.



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*Please note that this position is office based to be filled at our Raleigh, NC office location.

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What You'll Do


* Support Clinical Project Manager / Director in completing clinical project management activities; support activities throughout all phases of a clinical project, including any SOP-required deliverable as appropriate


* Update Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution


* Assist Clinical Project Manager / Director or Clinical Research Manager / Clinical Operations Director with preparing data reports for site and Clinical Research Associate (CRA) management; provide support for site management activities


* Develop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing and maintaining these presentations and documents as required per CTI Standard Operating Procedures (SOPs)


* Prepare initial drafts, including templates and content, of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team members


* Assist with tracking project scope and internal financial reporting


* Prepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internal and external team meetings


* Monitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management


* Manage and maintain CTI clinical system user account requests


* Support the review and tracking of site prescreening, screening, and enrollment activities as well as subject status information; follow up with internal clinical project team and/or sites as necessary regarding any identified issues


* Support tracking of action items and internal team follow-up


* Support and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities


* Assist the clinical project team and/or the Feasibility Department with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up


* Assist clinical project team with tracking and filing of clinical project plan and/or Standard Operating Procedure (SOP)-related deviations


* Support and maintain clinical project documents in paper and/or electronic Trial Master Files and support Clinical Project Manager / Director with TMF reconciliation and period review follow-up


* Create and com...