Senior CRA

5 days ago

Sydney, New South Wales, Australia ICON Strategic Solutions Full time
Overview

Title: Senior CRA (Biotech FSP)

Location: Melbourne (Australia), home-based

As a Senior Clinical Research Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

With the support of ICON right behind you, you will be joining an innovative Biotech company, with a vision to grow the team further in 2026 and 2027. Their mission is to develop, manufacture and commercialize high-quality medicines for the treatment of cancer and other major diseases. You will be working on first-in-class Oncology trials. You will not only have the opportunity to be part of a brand new team, but you will also have the opportunity to work on the full lifecycle of a trial, being involved from site identification, start-up and initiation through to close-out. This is a challenging career path that will support your growth and professional development and will broaden your expertise as a trial monitor.

What You Will Be Doing
  • Perform all aspects of generalist CRA duties from site selection, site activation, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
  • Lead site identification and initiation activities in Australia, including HREC/RGO process.
  • You will be embedded in our client\'s study team and have a dedicated ICON line manager to support you.
  • Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.
You Are
  • Degree in Pharmacy or any related course
  • 3.5+ years prior monitoring experience with global trials, including strong Oncology monitoring experience
  • Working experience with initial Australian ethics and regulatory submissions
  • Excellent communication skills
  • Adaptability and ability to work autonomously
  • Excellent knowledge of international guidelines ICH-GCP, good knowledge of local regulations
  • Flexibility to travel for monitoring visits as required
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Research, Analyst, and Information Technology
  • Industries: Pharmaceutical Manufacturing

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