Clinical Trial Specialist

18 hours ago

Perth, Western Australia beBeeClinical Full time $80,000 - $120,000

As a Clinical Research Associate, you will be responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies in accordance with standard operating procedures (SOPs), international conference on harmonization good clinical practice standard (ICH-GCP), and other applicable regulations.

The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time, and within budget. This includes but not limited to:

  • Study site selection, initiation, and clinical monitoring.
  • Performing pre-study visits to ensure eligible sites are selected according to sponsor site selection criteria, including adequate resources and experience.
  • Preparing and conducting Study Initiation Visits (SIV) to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
  • Ensuring Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP, and GCP.
  • Tracking study recruitment to ensure recruitment targets are achieved in all studies.
ResponsibilitiesSite Management

Key Responsibilities

  • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during, and at study close-down.
  • Maintain and update these documents in investigator files, trial master files.
  • Prepare/complete study records' archiving according to protocol and sponsor requirements.
Drug Safety

Key Responsibilities

  • Ensure safety information is disseminated to all sites according SOP and applicable regulations.
  • Ensure Serious Adverse Events (SAE) is reported within the timeline in compliance with SOPs and applicable regulations.
Finance and Administration

Key Responsibilities

  • Finalize budget and obtain signed contract from site prior to site initiation visit.
  • Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
Study Tools and Systems

Key Responsibilities

  • Update and maintain Study tools/systems in a timely manner.

This role requires a strong understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures. Additionally, strong skills on Microsoft Word, Excel, PPT, and Outlook are required.

This is an exciting opportunity to work unlocking community knowledge in a new way and making a difference in the field of pharmaceutical manufacturing.

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