Clinical Research Associate (CRA) – Medical Device

Contract: Freelance / Part‑Time Contract

Overview

We are supporting an cutting-edge 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 14155, 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
- Strong understanding of ISO 14155, 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

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📌 Clinical Research Associate - Medical Device (City of Sydney)
🏢 Hlx Life Sciences
📍 City of Sydney