Clinical Project Coordinator/Clinical Trial Assistant

What You'll Do

• Support Clinical Project Manager / Director in completing management activities; supports activities through all phases of a clinical project; provide back-up management as needed • 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 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 • Support the review and tracking of site pre-screening, 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 with developing feasibility surveys and survey content; participate in feasibility calls; assist with any site follow-up needed throughout start-up • Assist Clinical Project Manager / Director with documenting clinical project and 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 • Participate in preparing and following-up from internal and external audits; participate in audits as needed • Assist with the management of all clinical project-related supplies and drug management • Assist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.) • Provide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects • Assist with orientating new Clinical staff • Provide third party vendor support • Represent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness