Clinical Research Associate - Cell Therapy

Do you have expertise in complex clinical trial monitoring (like oncology)? Are you ready to make a difference in the world of clinical research in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease.

AstraZeneca Australia has been delivering the best value to patients for more than 60 years. We advance science to develop life-changing medicines.

In Cell Therapy Site Management & Monitoring (SMM), we partner closely with investigators and internal teams to initiate, run and close clinical studies efficiently and compliantly, so patients can access innovative treatments sooner.  

What you’ll do

As a Clinical Research Associate (CRA), you will be central to our local study teams. You will play a key role in delivering start‑up and monitoring for new, technically advanced cell therapy studies. You will work alongside Local Study Managers and peers to meet milestones reliably and ethically.

You'll be the primary contact for study sites, responsible for monitoring study conduct and ensuring compliance with international guidelines and local regulations. With opportunities for growth and additional responsibilities, this role is perfect for those looking to advance their career in clinical research!

This is a full time, 12-month contract position based in Sydney, reporting to the Senior Director, SMM Cell Therapy.  You’ll work remotely, travelling to sites and Head office in Sydney as needed.

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 for the role:

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification
• 1-2 years experience working at CRA level with independent monitoring experience, including site initiation, routine monitoring and close-out.
• Strong knowledge of international guidelines 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 AZ Therapeutic Areas.
• Demonstrated experience with Clinical Trial Management Systems and electronic TMF; familiarity with Veeva Clinical Vault or equivalent.
• Demonstrated ability to prioritize and manage multiple tasks with conflicting deadlines.
• Ability to travel for monitoring visits across Australia with current driving licence.
• Clear, confident communication and collaboration skills, with attention to detail and sound judgement in a fast‑paced environment.

Desirable:

• Manages change positively, seeing opportunities to grow.
• Ability to look for and champion continuous improvement to deliver high quality trials with reduced budget and in less time.
• Oncology or similarly complex monitoring experience.
• Experience within a pharmaceutical sponsor environment and comfort working with ambiguity beyond prescribed Contract Research Organisation processes.
• Familiarity with risk‑based and remote monitoring approaches and related tools.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next!

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Guidance on AI use: 

We support you using AI tools responsibly in the recruitment process in order for you to be at your best and showcase your knowledge, skills and abilities.    

Review our guide to help you do this: https://careers.astrazeneca.com/aiguidance

Where can I find out more?

• Visit our Global Website - https://www.astrazeneca.com/
• Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow us on Instagram – https://www.instragram.com/astrazeneca/

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Gold Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers.html  to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.

We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know via this Form.

Date Posted

Closing Date

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.