Clinical Research Professional

3 days ago

Sydney, New South Wales, Australia beBeeClinicalResearchAssociate Full time $90,000 - $120,000
Job Summary:

A Clinical Research Associate (CRA) plays a vital role in accelerating drug/device/outcomes research by independently monitoring studies to ensure patient safety and data integrity. We take a comprehensive approach, fostering a collaborative work environment through regular communication with our stakeholders.

  • Complete onsite and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
  • Qualify potential investigative sites, initiate clinical trials, maintain study files, provide instructions to site personnel, and conduct study close-out.
  • Verify the protection of study participants by confirming informed consent procedures and protocol compliance with applicable regulations.
  • Ensure the integrity of clinical data and compliance with approved protocol, GCP, applicable regulations, and SOPs.
  • Manage investigative site staff to facilitate trial deliverables, such as subject enrollment and data delivery.
  • Verify proper management and accountability of Investigational Product (IP).
  • Write and submit reports of investigational site findings and update tracking systems.
  • Evaluate observed deficiencies, issues, and corrective/preventative action plans.
  • Manage essential documents according to local regulations and ICH-GCP guidelines before, during, and after clinical studies.
  • Assist with resolving investigational site/data queries.

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