Freelance Clinical Research Associate (m/f/d)

EPM Scientific; Australia; Remote; AUD 83,000 - 124,000; Full time

Benefits offered by this job

Flexible freelance arrangement

Job summary

EPM Scientific, in partnership with a global medical device organisation, seeks an experienced freelance Clinical Research Associate to support clinical studies across Australia. The role focuses on site activation, regulatory submissions, and study maintenance with a strong emphasis on ICH-GCP and ISO 14155 compliance.

The ideal candidate will manage relationships with sites, Ethics Committees, and cross-functional teams, ensuring inspection-ready documentation and timely delivery.

Qualifications

• Strong background in clinical research within medical devices.
• Experience supporting and/or monitoring 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.

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.

Skills

Site activation

Regulatory submissions

ICH-GCP knowledge

Stakeholder management

Communication skills

Tools

eTMF

CTMS

Regulatory files

Job description

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)
• Strong 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