Job Description

Clinical Research Associate (CRA) – Medical Device

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Contract: Freelance / Part‐Time Contract

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Overview

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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.

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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.

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Key Responsibilities

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- Conduct site initiation, remote and on‐site monitoring, and close‐out visits across assigned studies
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- Ensure compliance with protocol, ISO 14155, ICH‐GCP, and applicable regulatory requirements
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- Support site management activities including recruitment tracking, data quality oversight, and issue escalation
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- Review source documentation, site files, and study documentation to ensure inspection readiness
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- Act as key point of contact between sponsor and study sites
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- Support study start‐up activities including feasibility,



site selection, regulatory submissions, and site activation
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- Track study progress, timelines, and site performance metrics
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- Collaborate closely with Clinical Operations, Data Management, and Medical teams
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Requirements

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- Previous CRA experience within medical device, biotech, pharma, or CRO environments
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- MUST HAVE: Structural heart, cardiovascular, electrophysiology, Watchman/LAAO, or related medical device experience highly preferred
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- Strong independent monitoring experience across regional or global studies
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- Strong understanding of ISO 14155, ICH‐GCP, and medical device clinical trial regulations
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- Excellent communication and stakeholder management skills
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- Ability to travel across sites as required within Australia
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- Freelancer/consultant setup required
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- Based in Sydney, Melbourne, or Brisbane preferred
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Feel free to apply, recommend relevant people in your network or reach out directly with your CV to [email protected]

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