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Job Overview:
The Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

We have some openings currently in all Australian capital cities with a single sponsor. Local travel preference can be accommodated.

Education/Qualifications:
Minimum Required: • University 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. • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements • Thorough knowledge of monitoring procedures • Basic understanding of the clinical trial process • Valid Driver's License

Preferred: • Thorough knowledge of Company SOPs regarding site monitoring

Experience:
Minimum Required: • A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted. • Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Good planning, organization and problem-solving abilities • Ability to work with minimal supervision • Good communication and interpersonal skills • Good analytical and negotiation skills • Computer competency • Fluent in local office language and in English, both written and verbal • Works efficiently and effectively in a matrix environment

Preferred: • One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred, however an equivalent combination of education and experience to successfully perform the key responsibilities of the job.