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Clinical Research Associate II (CRA2)

Job ID: 150488707
Job Views: 3
Location: Sydney, , Australia
Job Category: Health Care
Employment Type:

Job Description

Are you an exceptional Clinical Research Associate (CRA) based in Sydney or Melbou
e, Australia that has trial site monitoring experience and would like to expand your expertise in early clinical development Phase 1 oncology studiesClinical Research Associates manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.Responsibilities include:Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentationNegotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedStudy site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assignedSite management as prescribed in the project plansComplete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by managementMay support in organization of meetings and other tasks as instructed by supervisorRequirements:Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH GuidelinesExcellent understanding of Serious Adverse Event (SAE) reportingTypically 2+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).Knowledge of the Australia/ NZ site and regulatory environment is beneficial Covance Australia is committed to providing Clinical Research Associates; the flexibility to work from home, the freedom to grow careers across all phases and areas of clinical trial operations as well as provide cutting edge technology and processes that help to manage time and workload. About Covance: Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.Why CovanceAt Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world''s largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.Discover your potential in a company that truly invests in you. Talk to us to lea
more and explore your career. Apply online today.**

Hashtags Search #Sydney #Clinical Re #Covance

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