Clinical Research Associate Opportunity

2 days ago

Melbourne, Victoria, Australia beBeeResearch Full time $100,000 - $140,000
Job Title: Clinical Research Associate II

The role of a Clinical Research Associate II involves overseeing various aspects of study site monitoring, including routine visits and closeout of clinical sites, maintaining study files, conducting pre-study and initiation visits, and liaising with vendors.

  1. Responsible for all aspects of study site monitoring, ensuring compliance with regulatory requirements;
  2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to;
  3. Verify the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review;
  4. Monitor data for missing or implausible information;
  5. Prepare accurate and timely trip reports;
  6. Interact with internal work groups to evaluate needs, resources, and timelines;
  7. Act as contact for clinical trial supplies and other suppliers;
  8. Undertake feasibility work when requested;
  9. Participate in and follow-up on Quality Control Visits (QC) when requested;
  10. Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks assigned by supervisor;
  11. Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs;
  12. Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management;
  13. Assist with training, mentoring, and development of new employees, e.g. co-monitoring;
  14. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
  • About You
  1. University or college degree, or certification in a related allied health profession from an appropriately accredited institution;
  2. Demonstrated experience in onsite monitoring from SIV to Close-out;
  3. Understanding and experience in Australian Regulatory Guidelines;
  4. Happy to split time between the office and home (Hybrid).

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