What You’ll DoSupport 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 appropriateUpdate Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolutionAssist 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 activitiesDevelop initial drafts of clinical project plans, manuals, presentations, and other clinical project documents; assist in reviewing andmaintaining 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 membersAssist with tracking project scope and internal financial reportingPrepare initial drafts of detailed meeting agendas and minutes; assist in initial review of meeting documents prepared by others; attend routine internaland external team meetingsMonitor and maintain 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 information; follow up with internalclinical project team and/or sites as necessary regarding any identified issuesSupport tracking of action items and internal team follow-upSupport 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 and survey content; participate in feasibility calls; assist with any 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 deviationsSupport 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-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.Participate in preparing and following-up from internal and external audits; participate in audits as neededAssist with the management of all clinical project-related supplies and drug managementAssist 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 projectsAssist with orientating new Clinical staffProvide third party vendor supportRepresent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesivenessWhat You’ll BringBachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experienceAt least 1 year of experience in clinical research related fieldFluent in English

📌 Clinical Project Assistant/ Coordinator (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid