Job Title

Clinical Research Associate II, Melbourne basedJoin to apply for the Clinical Research Associate II, Melbourne based role at FortreaClinical Research Associate II, Melbourne based3 days ago Be among the first 25 applicantsJoin to apply for the Clinical Research Associate II, Melbourne based role at FortreaAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 15,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Fortrea CRAs EnjoyWorking on cutting edge global clinical trialsHave experienced & supportive managers to help grow CRA knowledge and skillsCareer development opportunitiesOpportunities to work for dedicated sponsors (FSP) and full service (GCD)Your Responsibilities IncludeResponsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assignedResponsible for all aspects of site management as prescribed in the project plansEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policyEnsure audit readiness at the site levelTravel, including air travel, may be required and is an essential function of the job.Prepare accurate and timely trip reportsInteract with internal work groups to evaluate needs, resources and timelinesAct as contact for clinical trial supplies and other suppliers (vendors) as assignedResponsible for all aspects of registry management as prescribed in the project plansUndertake feasibility work when requestedParticipate in and follow-up on Quality Control Visits (QC) when requestedRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgetsTrack and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training, mentoring and development of new employees, e.g. co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assignedAbout YouUniversity or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.Demonstrated experience in onsite monitoring from SIV to Close-outUnderstanding and experience in Australian Regulatory GuidelinesHappy to split time between the office and home (Hybrid)Learn more about our EEO & Accommodations request here.Seniority levelSeniority levelEntry levelEmployment typeEmployment typeFull-timeJob functionJob functionResearch, Analyst, and Information TechnologyReferrals increase your chances of interviewing at Fortrea by 2xGet notified about new Clinical Research Associate jobs in Melbourne, Victoria, Australia.South Yarra, Victoria, Australia 2 weeks agoAssistant CRA (FSP) | Remote Melbourne, Sydney or BrisbaneMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 3 weeks agoGraduate Clinical Research Associate -VictoriaMelbourne, Victoria, Australia A$100,000.00-A$140,000.00 1 week agoMelbourne, Victoria, Australia 3 weeks agoCRA (Level I) FSP | Melbourne, Sydney or BrisbaneMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 13 hours agoResearch Assistant, Evidence Synthesis and Research QualityMelbourne, Victoria, Australia 6 days agoMelbourne, Victoria, Australia 3 weeks agoMelbourne, Victoria, Australia 6 days agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 7 hours agoMelbourne, Victoria, Australia 6 hours agoResearch Officer Australia Dementia Network RegistryMelbourne, Victoria, Australia 3 days agoSouth Yarra, Victoria, Australia 1 week agoCountry Approval Specialist (FSP) | Melbourne, Sydney or BrisbaneMelbourne, Victoria, Australia 1 week agoFootscray, Victoria, Australia 12 hours agoParkville, Victoria, Australia 3 days agoMelbourne, Victoria, Australia 5 days agoClinical Research Coordinator (CMA, LPN or CNA)Research Assistant - Youth Mental HealthMelbourne, Victoria, Australia A$85,555.00-A$116,094.00 1 week agoMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 3 weeks agoAssociate Clinical Trial Manager - PhD / Post-Doc - Infectious DiseaseSouth Yarra, Victoria, Australia 3 days agoClinical Research Associate II/ Senior Clinical Research AssociateMelbourne, Victoria, Australia 2 weeks agoClinical Specialist Cardiac Rhythm ManagementMelbourne, Victoria, Australia 1 week agoAssociate Clinical Trial Manager - PhD / Post-Doc (Oncology)South Yarra, Victoria, Australia 1 week agoFootscray, Victoria, Australia 3 days agoSenior Clinical Research Associate I (SCRA1), FSP modelMelbourne, Victoria, Australia 3 days agoMelbourne, Victoria, Australia A$300,000.00-A$350,000.00 1 week agoResearch Assistant - Digestive PhysiologyMelbourne, Victoria, Australia A$122,212.00-A$145,121.00 1 week agoMelbourne, Victoria, Australia 5 days agoWere unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr