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.
Responsibilities:
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.
Qualifications:
You are:
* Degree in Pharmacy or any related course
* 3.5+ years prior monitoring experience with global trials, including strong Oncolgoy monitoring experience
* Working experience with initial Australian ethics and regulatory submissions
* Excellent communication skills
* Adapatability and ability to work autonoumously
* Excellent knowledge of international guidelines ICH-GCP, good knowledge of local regulations
* Flexibility to travel for monitoring visits as required
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