About the job:Responsible for supporting management efforts of Clinical Project Managers and Directors, ensuring timelines, budgets and quality standards are being achieved.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 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 cohesivenessRegionally-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 / Director Support RWE activities as needed in the region Report to Clinical Research Manager (CRM) What You'll Bring:Bachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science or an equivalent combination of education and relevant work experience 0-2 years of experience in clinical research related field; candidates with fewer years of experience may be considered based on professional experience and/or educationCompetencies:Basic knowledge of medical and pharmaceutical terminologyBasic awareness and knowledge of the drug development and clinical trial processBasic awareness and knowledge of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirementsGood verbal and written communication skills in English (and local language)Good organizational and record retention skillsGood customer service and interpersonal skillsAbility to successfully work within a team-based environmentAbility to follow instruction under team member guidanceAbility to handle multiple tasks and manage time efficientlyBasic computer literacy and familiarity with Microsoft Office SuiteAbout CTICTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.comWhy CTI?Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.Important 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 messageWe will never ask for your bank account information at any point during the recruitment process