Clinical Research Associate (I) (City of Sydney)

Do you want to be a part of a team that bring breakthrough therapies to patients across Australia and beyond, while building your career in a world‑class clinical environment? Novo Nordisk has a strong reputation and relationships with trial sites in Australia, supported by a global philosophy and tradition centred on research and clinical trials in all our therapy areas. Your new role As a Clinical Research Associate, you’ll be the vital link between Novo Nordisk, clinical trial sites, and cross‑functional study teams across Australia. This role covers the Sydney metropolitan area and offers you the opportunity to grow your professional independence while ensuring patient safety, data integrity, and protocol compliance across assigned clinical trial sites. You’ll drive study quality through risk-based monitoring, proactive risk management, and strong site relationships—all while contributing to breakthrough therapies that defeat serious chronic diseases. Your Key Responsibilities
- Serve as the main liaison with clinical sites, conducting monitoring visits to ensure protocol compliance, patient safety, and overall study quality.
- Build and maintain strong site relationships while providing ongoing training, support, and guidance on protocols, procedures, and compliance requirements.
- Ensure data integrity and regulatory compliance by monitoring data, resolving discrepancies, managing adverse events, and maintaining inspection‑ready documentation (e.g., TMF).
- Oversee site performance, including recruitment, retention, and data collection, while managing investigational products, supplies, and equipment to meet study timelines.
- Drive efficient study execution through cross‑functional collaboration and implementation of risk‑based quality management (RBQM) to identify and mitigate risks. Your new department Within Clinical Development sits CDC Oceania, where you’ll report directly to the Manager, Clinical Operations. This team is responsible for the oversight and management of clinical trials across Australia, ensuring the highest standards of quality, compliance, and patient safety. Your work will directly contribute to bringing Novo Nordisk’s creative pipeline to patients living with diabetes, obesity, and other serious chronic diseases across the region. Your Skills & Qualifications
- Bachelor’s degree in Life Sciences (or related field).
- Minimum 6 months’ experience as a Clinical Research Associate.
- Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial methodology, with high attention to quality and patient safety.
- Excellent communication and stakeholder management skills, with the ability to build relationships and work effectively both independently and in teams.
- Proficiency in clinical systems (EDC, CTMS, eTMF) and AI proficiency combined with robust organisational, time management, and project management skills to manage multiple priorities.
- Strong problem‑solving and decision‑making abilities, proactive risk management mindset, openness to continuous improvement, and flexibility to travel. Deadline 30 May 2026. Applications are reviewed on an ongoing basis. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rwlb0