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.

Please note that this position is office based to be filled at our headquarters office in Covington, KY or the Raleigh, NC office location.

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 perio...