Clinical Trial Professional

2 days ago

Sydney, New South Wales, Australia beBeeCareer Full time $200,000 - $250,000
Clinical Research Associate II: A Career in Clinical Trials

As a leading global contract research organization, we provide customers with a wide range of clinical development solutions across multiple therapeutic areas. Our team is passionate about scientific rigor and has decades of experience in clinical development.

  • Monitoring cutting-edge global clinical trials
  • Experienced managers to help grow knowledge and skills
  • Career development pathways
  • Opportunities to work for dedicated sponsors (FSP) and full-service organizations (FSO)
Responsibilities:
  • Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaison with vendors; and other duties as assigned
  • Responsible for all aspects of site management as prescribed in the project plans
  • Ensure the study staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements
  • Ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
  • Ensure resources are spent wisely by performing required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion
  • Ensure audit readiness at the site level
  • Prepare accurate and timely trip reports
  • Participate in and follow-up on Quality Control Visits (QC) when requested
  • Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs

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