Client Profile

Liberte HR is partnered with a growing boutique CRO with a global presence, supporting global biotechnology and pharmaceutical studies across a broad range of therapeutic areas. Due to continued expansion across Australia, they are looking to appoint a Senior/Clinical Research Associate to join their Melbourne-based clinical operations team.

This opportunity would suit candidates who enjoy working in a collaborative, fast-paced environment with strong exposure across regional and global studies.

The Opportunity

Reporting into Clinical Operations leadership, you will be responsible for site management and monitoring activities across clinical trials conducted within Australia. You will work closely with investigative sites and cross-functional project teams to ensure studies are delivered in compliance with protocol, ICH-GCP guidelines, and regulatory requirements.

This is a Melbourne-centric role with hybrid flexibility and travel across sites as required.

Key Responsibilities

• Perform site selection, initiation, routine monitoring, and close-out visits in accordance with protocol, GCP, ICH guidelines, and regulatory requirements.
• Build strong working relationships with investigative sites and maintain regular communication throughout the study lifecycle.
• Support and track patient recruitment and enrolment activities in line with study timelines.
• Deliver protocol and study-specific training to site staff where required.
• Evaluate site performance, protocol compliance, and data quality, escalating risks or quality concerns appropriately.
• Track study progress including regulatory submissions, site activations, recruitment, CRF completion, and query resolution.
• Ensure Trial Master File (TMF) and Investigator Site File (ISF) documentation is maintained appropriately and audit-ready.
• Prepare monitoring reports, follow-up letters, and related study documentation within required timelines.
• Collaborate closely with Clinical Operations, Start-Up, Data Management, and project teams to support study execution.
• Support study start-up and site financial management activities where applicable.

Candidate Profile

• Bachelor's Degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or related discipline.
• Prior on-site monitoring experience within a CRO, biotech, or pharmaceutical environment.
• Strong understanding of ICH-GCP and applicable clinical research regulatory requirements.
• Ability to work independently while managing multiple sites and priorities.
• Strong communication, stakeholder management, and organisational skills.
• Proficiency in Microsoft Office including Word, Excel, and PowerPoint.
• Full Australian work rights required.

Candidates will be considered across CRA and Senior CRA levels depending on experience.