Role Overview
As a Clinical Research Associate (CRA), you will be central to our local study teams, responsible for initiating, monitoring, and closing clinical studies in cell therapy and other advanced treatment areas, ensuring that studies are conducted safely, efficiently, and in compliance with applicable regulations.
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 of CRA level experience with independent monitoring, including site initiation, routine monitoring and close‐out.
* Strong knowledge of ICH‐GCP and Australian regulatory requirements.
* Sound medical knowledge and ability to learn relevant AZ therapeutic areas.
* Demonstrated experience with Clinical Trial Management Systems and electronic TMF; familiarity with Veeva Clinical Vault or equivalent.
* Ability to prioritize and manage multiple tasks with conflicting deadlines.
* Willingness to travel across Australia for monitoring visits 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
* Ability to adapt to change and view opportunities for growth.
* Champion continuous improvement to deliver high quality trials with reduced budget and time.
* Oncology or similar complex monitoring experience.
* Experience within a pharmaceutical sponsor environment and ability to work with ambiguity beyond contract research organisation processes.
* Familiarity with risk‐based and remote monitoring approaches and related tools.
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 comply with all applicable laws and regulations on non‐discrimination in employment and work authorization.
#J-18808-Ljbffr