Clinical Research Associate - Medical Device

Clinical Research Associate (CRA) – Medical Device

Location: Sydney / Melbourne / Brisbane - preferred

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 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 ***email_hidden***