Clinical Research Associate (I) and (II)

Role overview

Join a global clinical development team helping advance breakthrough therapies for patients across Australia and beyond. In this Sydney-focused position, you will act as the key connection point between the company, study sites, and internal project teams. The role is centered on protecting participant safety, maintaining high-quality data, and keeping studies aligned with protocol and regulatory standards.

What you will do

• Act as the primary contact for assigned clinical trial sites and carry out monitoring visits to confirm protocol adherence, participant safety, and study quality.
• Develop productive site partnerships and provide continued coaching and support on study procedures, protocols, and compliance expectations.
• Review study data, address inconsistencies, manage adverse event follow-up, and keep trial documentation complete and ready for inspection, including TMF records.
• Track site performance across recruitment, retention, and data entry, while overseeing investigational products, materials, and equipment so milestones stay on schedule.
• Work closely with cross-functional colleagues to support efficient study delivery and apply risk-based quality management to identify and reduce operational risks.

Team and environment

You will be part of Clinical Development within CDC Oceania and report to the Manager, Clinical Operations. The group oversees clinical trials across Australia with a strong focus on quality, compliance, and participant safety. Your work will support the development of treatments for diabetes, obesity, and other serious long-term conditions.

Skills and qualifications

• A bachelor’s degree in Life Sciences or a closely related discipline.
• At least 6 months of experience working as a Clinical Research Associate.
• Solid understanding of ICH-GCP, regulatory expectations, and clinical trial processes, with a strong focus on quality and patient safety.
• Strong written and verbal communication skills, plus the ability to manage stakeholder relationships and collaborate effectively both alone and in teams.
• Hands-on experience with clinical platforms such as EDC, CTMS, and eTMF, along with AI proficiency, strong organisation, time management, and project coordination skills.
• Confidence in problem-solving and decision-making, a proactive approach to risk management, openness to continuous improvement, and flexibility to travel.

About the employer

The organisation is committed to improving long-term health by developing solutions for serious chronic diseases. It promotes a culture of learning, collaboration, innovation, personal growth, and autonomy, and values inclusive hiring and equal opportunity for all applicants.

Application information

The closing date is 13 June 2026, and applications are assessed as they are received.

Additional information

This opportunity is offered in the Greater Sydney Area and involves onsite work. No stipend, salary, or vacancy count was specified in the source.