Senior Clinical Research Associate I (SCRA1), FSP modelJoin to apply for the Senior Clinical Research Associate I (SCRA1), FSP model role at FortreaSenior Clinical Research Associate I (SCRA1), FSP model3 days ago Be among the first 25 applicantsJoin to apply for the Senior Clinical Research Associate I (SCRA1), FSP model role at FortreaJob OverviewThe Senior CRA I is responsible for site monitoring and site management.
Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines.
The Senior CRA I assure the implementation of project plans, as assigned.
Function as leader for projects of limited scope, as assigned.
Assume line management responsibilities, as assigned.
Act in the project role of a Local Project Coordinator or Lead CRA as assigned.Job OverviewThe Senior CRA I is responsible for site monitoring and site management.
Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines.
The Senior CRA I assure the implementation of project plans, as assigned.
Function as leader for projects of limited scope, as assigned.
Assume line management responsibilities, as assigned.
Act in the project role of a Local Project Coordinator or Lead CRA as assigned.Summary Of ResponsibilitiesResponsible 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 assigned.Responsible for all aspects of site management as prescribed in the project plans.Qualifications (Minimum Required)University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.Thorough understanding of the drug development process.Fluent in local office language and in English, both written and verbal.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.Experience (Minimum Required)Typically Three (3) years of clinical onsite monitoring experience.Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.Advanced site monitoring skills.Advanced study site management skills.Advanced registry administration skills.Ability to work with minimal supervision.Valid Driver's License.Physical Demands/Work EnvironmentTravel requirements: *****%Learn more about our EEO & Accommodations request here.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionResearch, Analyst, and Information TechnologyReferrals increase your chances of interviewing at Fortrea by 2xGet notified about new Senior 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,******-A$140,******** week agoMelbourne, Victoria, Australia 3 weeks agoCRA (Level I) FSP | Melbourne, Sydney or BrisbaneMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 7 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 agoResearch Officer – Australia Dementia Network RegistryMelbourne, Victoria, Australia 2 days agoMelbourne, Victoria, Australia 1 hour agoSouth Yarra, Victoria, Australia 1 week agoCountry Approval Specialist (FSP) | Melbourne, Sydney or BrisbaneMelbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 4 days agoFootscray, Victoria, Australia 5 hours agoParkville, Victoria, Australia 2 days agoClinical Research Coordinator (CMA, LPN or CNA)Melbourne, Victoria, Australia 55 minutes agoResearch Assistant - Youth Mental HealthMelbourne, Victoria, Australia A$85,******-A$116,******** week agoClinical Research Associate II, Melbourne basedMelbourne, Victoria, Australia 3 days 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 agoMelbourne, Victoria, Australia A$300,******-A$350,******** week agoResearch Assistant - Digestive PhysiologyMelbourne, Victoria, Australia A$122,******-A$145,******** week agoMelbourne, Victoria, Australia 4 days agoWe're unlocking community knowledge in a new way.
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