In House CRA

In-House Clinical Research Associate (IHCRA)

Home-Based | Melbourne or Sydney

Join ICON in a Functional Service Provider (FSP) partnership supporting a global biopharmaceutical organisation delivering innovative clinical development programs.

We are seeking an In-House CRA (IHCRA) to provide critical centralized support to CRAs and study teams, playing a key role in site management, remote monitoring, and study coordination activities.

The Opportunity

This role is ideal for candidates with CRO or pharmaceutical experience, or experienced Study Coordinators looking to transition into a sponsor-aligned environment and gain exposure to monitoring activities.

You will work closely with CRAs and cross-functional teams to ensure clinical trials are delivered efficiently, compliantly, and to the highest quality standards.

Key Responsibilities

• Provide centralized support to CRAs in managing investigative sites
• Perform remote monitoring activities, including EDC and data review
• Track site performance, patient recruitment, and data entry timelines
• Liaise with sites to follow up on queries, documentation, and action items
• Support study start-up activities, including site documentation and supplies coordination
• Assist with eTMF review and quality control at site and country level
• Support preparation and follow-up of monitoring visits
• Act as a key contact for sites between monitoring visits
• Assist with contract and site documentation processes where required
• Contribute to study tracking, reporting, and communication across teams

What We’re Looking For

• Bachelor’s degree in Life Sciences or related field (or RN qualification)
• 2–3 years’ clinical research experience within a CRO, pharmaceutical company, or as a Study Coordinator
• Strong understanding of ICH-GCP, clinical trial processes, and regulatory requirements
• Experience with EDC, CTMS, and clinical trial systems
• Excellent organisational and communication skills
• High attention to detail with strong problem-solving capability
• Ability to manage multiple priorities and work independently
• Comfortable working in a fast-paced, matrix environment

Why Join?

• Excellent opportunity for Study Coordinators transitioning into CRA pathways
• Gain exposure to remote monitoring and site management activities
• Work within a supportive, collaborative, and high-performing team
• Strong career development opportunities within clinical operations

Additional Information

• Location: Home-based (Melbourne or Sydney)
• Travel: Occasional travel may be required

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