EPM Scientific is partnering with a global medical device organisation seeking experienced freelance Clinical Research Associates to support clinical studies across Australia.
Key Requirements:
- Strong background in clinical research within medical devices
- Experience supporting and/or monitoring clinical trials from start-up through close-out, including site activation, regulatory submissions, and study maintenance activities
- Knowledge of ICH-GCP, ISO 14155, and applicable local regulatory requirements
- Experience working with clinical sites, Ethics Committees, and study documentation (eTMF, CTMS, regulatory files)
- Solid stakeholder management and communication skills
Responsibilities:
- Support site start-up, regulatory submissions, site activation, enrollment, follow-up, and close-out activities
- Ensure study documentation is accurate, complete, and inspection-ready throughout the study lifecycle
- Act as the primary liaison between study teams, sites, and cross-functional stakeholders
- Monitor study progress, identify risks, and support successful trial delivery
- Maintain compliance with ICH-GCP, ISO 14155, SOPs, and local regulations
- Start Date: Jan 2027
- Location: Australia (Remote)
- Contract Type: Freelance
- Commitment: 1.0 FTE
- Duration: Initial 12-month contract with strong possibility of extension
- Rate: Competitive hourly rate, dependent on experience