CPA

About The JobResponsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets and quality standards are being achieved.What You'll DoClinical Project Manager / Director in completing clinical project management activities; support activities throughout all phases of a clinical project, including any SOP-required deliverable as appropriateUpdate Clinical Project Manager / Director on progress, outstanding items, and issues with assigned tasks/responsibilities as they ariseAssist 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 activitiesAssist in development of initial drafts of clinical project plans, manuals, presentations, and other clinical project documents for review; update as requested by clinical project teamUnder the direction of the clinical project team, prepare initial drafts of internal reports, external reports, newsletters, and other clinical project communications; distribute reports and communications to sites, vendors, Sponsors, and internal team membersPrepare initial drafts of meetings agendas and minutes in collaboration with Clinical Project Manager; attend routine internal and external team meetingsMaintain tracking tools, clinical systems, and shared document repositories utilized for clinical project managementManage and maintain CTI clinical system user account requestsSupport the review and tracking of site prescreening, screening, and enrollment activities as well as subject status informationSupport tracking of action itemsSupport and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activitiesAssist the clinical project team and/or the Feasibility Department with developing feasibility surveys; participate in feasibility calls; assist with site follow-up needed throughout start-upAssist clinical project team with tracking and filing of clinical project plan and/or Standard Operating Procedure (SOP)-related deviationsReceive and submit/distribute clinical project-related documentation; set up and maintain paper and electronic Trial Master Files; and support TMF reconciliation and periodic review follow-upCreate and compile the Investigator Site File and Pharmacy Binde or Study Manual in collaboration with CPM/RASSU/Clinical Monitoring. Organize shipments to CRA/Site. Includes set-up and maintenance of Index with Comments.Assist clinical project team with internal and external audit preparation and follow-upAssist with the provision of all clinical project-related supplies and drug management; compile and ship supplies to sitesAssist 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 Assistants and Research Associates (RAs) in clinical projectsAssist with orientating new Clinical staffProvide third party vendor supportRepresent CTI in a professional manner and foster collaboration with all clinical project teams/ functional departments; assist in promoting interdepartmental cohesiveness Regionally-Specific Essential Functions: MEAManage receipt and first review of site and vendor invoices, process subject milestones payments per scope, prepare payment requests for internal review / approval, assist in the preparation of payment projections, and maintain payment records; escalate any issues with invoices to Clinical Project Manager / DirectorSupport RWE activities as needed in the regionReport to Clinical Research Manager (CRM)What You Bring0-2 years of experience in clinical research related field; candidates with fewer years of experience may be considered based on professional experience and/or educationImportant NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.Please NoteWe will never communicate with you via Microsoft Teams or text message.We will never ask for your bank account information at any point during the recruitment process.