Clinical Trials Manager

5 days ago

Sydney, New South Wales, Australia beBeeResearch Full time $200,000 - $250,000
Job Summary:

The Senior Clinical Research Associate is responsible for overseeing all aspects of study site management to ensure high quality data. This involves monitoring clinical trials, ensuring that projects are conducted in accordance with applicable SOPs, regulations and ICH guidelines.

  • Act as a member of the project team to contribute towards efficient management of trials
  • Perform Site Qualification Visits: discuss protocol and other available study documentation with Investigator and other trial staff to ensure that trial staff and site facilities meet protocol requirements and local regulations, ICH-GCP and G CRO's SOPs
  • Support feasibility, site selection and start up activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions with sites
  • Negotiate site budgets and assist with the execution of site contracts with support from the Project Manager
  • Perform Site Initiation Visits: train Investigators and other trial staff in the protocol and data collection methods to ensure accurate and complete patient data, conforming to protocol requirements and local regulations, ICH-GCP and GC CRO's SOPs
  • Perform Interim Monitoring Visits: ensure adherence to protocol and monitor participant source data via source document verification per the monitoring plan, perform Investigational Product accountability and meet with site staff to ensure study procedures are conducted in accordance with the protocol and ICF GCP
  • Perform Site Close Out Visits

Key Requirements:

  • Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
  • At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical and/or Biotechnology industry as a SCRA/CRA
  • Experience in managing early phase oncology trials is highly preferred

Benefits:

This role offers opportunities to work directly with sponsors on assigned projects, internal and external training and development opportunities, and more.

As a key member of our project team, you will have the opportunity to learn every day and own your development in this challenging and rewarding role.

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