Get AI-powered advice on this job and more exclusive features.This range is provided by Hlx Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeA$150.00/yr - A$175.00/yrWe're seeking a Senior Clinical Research Associate (CRA) for my client, a tech-enabled CRO that is transforming how technology is used in clinical trials with AI. In this role, the CRA will oversee clinical trial sites within a designated region, ensuring compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. Acting as the primary point of contact for assigned sites, they will facilitate communication between site personnel and the client. Key responsibilities include conducting site visits, managing essential document collection and review, and preparing detailed trip reports to summarize monitoring activities.Essential Functions of the job:Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance.Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actionsIdentifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious issues to the project team and develops action plans.Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.Verifies site processes to obtain informed consent have been adequately performed and documents for each subjectAssess site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring PlanPerforms Source Data Review/Source Data Verification for assigned clinical trial sitesReviews investigational product inventory, reconciliation and storage at trial sites, ensure GCP guidelines are followedReviews the Investigator Site File for accuracy and completenessProvides site and regional metrics into trackers to support project-level report generationUnderstands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions.Qualifications:Minimum of 2 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacityStrong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines.Demonstrated ability in report writing and strong ability to critically understand clinical research documentsExcellent organizational and communication skills.Ability to work collaboratively in a fast-paced, dynamic environment.Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlinesProficient with Microsoft Office Suite, Project Management tools. Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionAccounting/Auditing, Administrative, and ResearchIndustriesBiotechnology Research and Research ServicesReferrals increase your chances of interviewing at Hlx Life Sciences by 2xGet notified about new Clinical Research Associate jobs in Greater Sydney Area.Sydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 14 hours agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 1 year agoNorth Ryde, New South Wales, Australia 4 hours agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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