Clinical Research Associate

vor 1 Woche

Council of the City of Sydney, Österreich AstraZeneca Vollzeit

Clinical Research Associate (CRA) - AstraZeneca We’re hiring a Clinical Research Associate (CRA) or Senior CRA to join our Site Monitoring and Management (SMM) team. Your role will support the launch, monitoring, and close‑out of clinical studies in our Cell & Gene Therapy programmes in Australia (Sydney or Melbourne). What You’ll Do As a CRA, you will play a pivotal role in ensuring the quality and speed of our clinical trials: Engage investigators and drive site activation and performance. Coordinate start‑up, regulatory submissions, approvals, and essential documents. Train and oversee site teams on ICH‑GCP, RbQM, and SAE reporting. Conduct remote and on‑site monitoring visits, source data reviews, and manage data queries. Ensure timely SAE reporting and resolve quality issues in line with AZ SOPs. Maintain CTMS/eTMF, manage study supplies, and produce monitoring reports. Essential Qualifications Bachelor’s degree in life sciences or equivalent. Strong knowledge of ICH‑GCP, basic GMP/GDP, and Australian clinical regulations. Proven experience in site start‑up, monitoring, drug handling, data management and SAE processes. Detail‑oriented with robust documentation and inspection readiness. Excellent written and verbal communication; ability to collaborate and negotiate with site teams. Willingness to travel to site locations and possess a valid driver’s licence. Desirable Qualifications Experience in haematology or autoimmune trials (e.g., multiple myeloma, MS, RA). Familiarity with risk‑based monitoring, remote monitoring, and RbQM. Proactive process improvement mindset and problem‑solving skills. Digital fluency with eTMF/CTMS and leveraging technology for efficiency. Ability to thrive in distributed teams with cultural awareness and manage competing deadlines. Why AstraZeneca AstraZeneca is a global, science‑led biopharmaceutical company dedicated to breakthrough medicines. We offer a collaborative environment with robust training, modern systems, and a culture that champions diversity, inclusion, and lifelong learning. Application Details Date Posted: 25‑Nov‑2025Closing Date: 14‑Dec‑2025 AstraZeneca embraces diversity and equal opportunity. We welcome applications from all qualified candidates regardless of background. We accommodate applicants with accessibility needs – please let us know how we can support you. To apply, visit our careers page: AstraZeneca Careers .Follow us on LinkedIn: AstraZeneca LinkedIn EEO Statement AstraZeneca is an equal opportunity employer. We are committed to building an inclusive and diverse team and comply with all applicable non‑discrimination laws. #J-18808-Ljbffr

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