ph3What You’ll Do /h3 ul liSupport 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 /li liUpdate Clinical Project Manager / Director on progress, outstanding items, and issues as they arise; support Clinical Project Manager / Director with issue resolution /li liAssist 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 /li liDevelop 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) /li liPrepare 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 /li liAssist with tracking project scope and internal financial reporting /li liPrepare 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 /li liMonitor and maintain tracking tools, clinical systems and shared document repositories utilized for clinical project management /li liManage and maintain CTI clinical system user account requests /li liSupport 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 /li liSupport tracking of action items and internal team follow-up /li liSupport and prepare / maintain tracking of clinical project start-up activities and milestones, including site selection and site start-up activities /li liAssist 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 /li liAssist clinical project team with tracking and filing of clinical project plan and/or Standard Operating Procedure (SOP)-related deviations /li liSupport 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 /li liCreate 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. /li liParticipate in preparing and following-up from internal and external audits; participate in audits as needed /li liAssist with the management of all clinical project-related supplies and drug management /li liAssist other departments as needed throughout all phases of clinical projects (e.g., Regulatory Affairs Study Start-up, Data Management, Safety, etc.) /li liProvide support in developing new Clinical Project Coordinators, Clinical Project Assistants, and Research Associates (RAs) in clinical projects /li liAssist with orientating new Clinical staff /li liProvide third party vendor support /li liRepresent CTI in professional manner and foster collaboration with all clinical project teams / functional departments; assist in promoting interdepartmental cohesiveness /li /ul h3What You’ll Bring /h3 ul liBachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience /li liAt least 1 year of experience in clinical research related field /li liFluent in English /li /ul /p #J-18808-Ljbffr

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