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May

Senior Clinical Research Associate

Planet Pharma - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Planet Pharma is partnered with a medium-sized, growing Clinical Research Organisation that is seeking a Senior CRA to join them on a permanent basis. The CRA proactively identifies, resolves/mitigates, and escalates risks and/or issues, may be responsible for multiple studies, and must work independently with team support. The position is fully home-based in Australia.


  • Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
  • Maintains submission of expenses according to travel and expense requirements within company guidelines
  • Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol, and client requirements
  • Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
  • Plans day to day activities for monitoring of a clinical study and sets priorities per site
  • Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required by clinical monitoring plan.


REQUIREMENTS:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (i.e., registered nurse); 

Melbourne, VIC

Health, Medical & Pharmaceutical




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