Clinical Research Associate - Cell Therapy

Clinical Research Associate (CRA) Full‑time, 12‑month contract based in Sydney. Remote work with occasional travel to study sites and the head office. Reporting to the Senior Director, SMM Cell Therapy. Key Responsibilities Contribute to selection of potential investigators and support site feasibility. Manage study start‑up and regulatory maintenance, including preparing and submitting documents. Train and support site staff on study requirements, maintain inspection readiness and ensure completion of mandatory trainings. Initiate, monitor and close study sites in line with AstraZeneca Procedural Documents, protocols and local regulations. Perform monitoring visits and data checks per the Monitoring Plan, including Source Data Review, Source Data Verification, Case Report Form review, and drug accountability. Maintain study systems and documentation (e.g., Clinical Trial Management System and electronic Trial Master File). Report Serious Adverse Events promptly and support audits and inspections. Essential Qualifications Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification. 1–2 years experience as a CRA with independent monitoring experience, including site initiation, routine monitoring and close‑out. Strong knowledge of ICH GCP and good knowledge of Australian regulatory requirements, with the ability to apply these in day‑to‑day monitoring. Sound medical knowledge and ability to learn relevant AstraZeneca Therapeutic Areas. Demonstrated experience with Clinical Trial Management Systems and electronic TMF; familiarity with Veeva Clinical Vault or equivalent. Demonstrated ability to prioritise and manage multiple tasks with conflicting deadlines. Ability to travel for monitoring visits across Australia with a current driving licence. Clear, confident communication and collaboration skills, with attention to detail and sound judgement in a fast‑paced environment. Desirable Qualifications Positive attitude to change and seeking opportunities to grow. Drive for continuous improvement to deliver high‑quality trials with reduced budget and time. Experience in oncology or similarly complex monitoring. Experience within a pharmaceutical sponsor environment and comfort working with ambiguity beyond prescribed CRO processes. Familiarity with risk‑based and remote monitoring approaches and related tools. Legal Notice AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr