Clinical Research Associate (CRA) – Medical Device
Contract: Freelance / Part‐Time Contract
Overview
We are supporting an innovative cardiovascular medical device organisation focused within structural heart technologies, currently looking to appoint an experienced freelance CRA to support ongoing clinical studies across key sites in Australia.
This is a consulting, hands‐on role focused on site monitoring, study oversight, and supporting operational delivery across complex medical device studies within a fast‐paced clinical environment.
Key Responsibilities
Conduct site initiation, remote and on‐site monitoring, and close‐out visits across assigned studies
Ensure compliance with protocol, ISO *****, ICH‐GCP, and applicable regulatory requirements
Support site management activities including recruitment tracking, data quality oversight, and issue escalation
Review source documentation, site files, and study documentation to ensure inspection readiness
Act as key point of contact between sponsor and study sites
Support study start‐up activities including feasibility,



site selection, regulatory submissions, and site activation
Track study progress, timelines, and site performance metrics
Collaborate closely with Clinical Operations, Data Management, and Medical teams
Requirements
Previous CRA experience within medical device, biotech, pharma, or CRO environments
MUST HAVE: Structural heart, cardiovascular, electrophysiology, Watchman/LAAO, or related medical device experience highly preferred
Strong independent monitoring experience across regional or global studies
Solid understanding of ISO *****, ICH‐GCP, and medical device clinical trial regulations
Excellent communication and stakeholder management skills
Ability to travel across sites as required within Australia
Freelancer/consultant setup required
Based in Sydney, Melbourne, or Brisbane preferred
Feel free to apply, recommend relevant people in your network or reach out directly with your CV to ******
#J-*****-Ljbffr

📌 Clinical Research Associate - Medical Device (New South Wales)
🏢 Hlx Life Sciences
📍 New South Wales