Senior Cra

4 days ago

Melbourne, Victoria, Australia Pharmaceutical Research Associates, Inc 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.
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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