Clinical Research Associate - CRA (Level Depending on Experience)Job Category: Clinical MonitoringRequisition Number: CLINI001314Posted: November 15, 2024Full-TimeLocationsShowing 1 locationAustralia478 George StreetLevel 3Sydney, NSW 2000, AUSCTI 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.What Youll DoServe as main CTI contact for assigned study sitesConduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with or oversee study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings; may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project TeamParticipate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required proceduresWhere applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is availableProvide regular updates to Sponsor/ ClientWhere applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site paymentsManage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring PlansIdentify and anticipate site issues and implement corrective and preventive actions or escalate as appropriateLiaise with Clinical Data Management for data cleaning activitiesServe as mentor / trainer for CRAs; may include conducting training/assessment visitsFunction in the role of Lead CRA for assigned project(s)Identify and propose process improvementsProvide therapeutic area expertise to team membersWhat You BringAt least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human ResourcesBachelor''s Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate''s Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human ResourcesPrevious experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRAYou need to be fully eligible to work in Australia - CTI does not provide VISA SponsorshipThe role is meant in a hybrid setting in SydneyWhy 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.We 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 #J-18808-Ljbffr
Job Title
Clinical Research Associate - CRA (Level Depending on Experience)