Clinical Research Associate - Multiple Roles at AstraZeneca

South Turramurra, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

25 May, 26

Salary

0.0

Posted On

24 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Site Activation, Risk-Based Monitoring, Patient Safety, Data Integrity, Protocol, Site Selection, EC/IRB Submissions, ICH-GCP, RbQM, Source Data Review, Source Data Verification, CRF Review, CTMS, eTMF, Stakeholder Management, Problem-Solving

Industry

Pharmaceutical Manufacturing

Description

We currently building out our teams across Biopharma and Oncology, and we have a number of vacancies for Clinical Research Associates with a view to commence in role throughout March and April 2026. At AstraZeneca, we’re united by a bold ambition: to transform patients’ lives through science. Across BioPharma and Oncology, we design and deliver high‑quality, patient‑centric clinical trials that translate deep biology into breakthrough medicines in cardiovascular, renal & metabolism, respiratory & immunology, and cancers where the need is greatest. As a Clinical Research Associate, you will own site activation and performance, direct risk-based monitoring to where it matters most, and safeguard patient safety and data integrity. You will partner with investigators, shape inspection readiness, and apply a forward-looking approach that challenges the status quo and accelerates launches. How will you use your judgment and influence to turn a promising protocol into a reliable, scalable trial outcome. What you’ll do Identify and evaluate sites and investigators, build collaborative relationships, and drive activation, enrolment and sustained performance. Coordinate EC/IRB and health‑authority submissions, secure and maintain approvals, and manage essential documents to keep studies inspection‑ready from day one. Train and support site teams on ICH‑GCP and RbQM, embed compliance routines, and coach toward audit and inspection readiness. Conduct remote and onsite monitoring visits; perform Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (CRF) review; manage data queries; and adjust monitoring intensity based on risk signals. Ensure timely reporting of Serious Adverse Events (SAEs); proactively identify, escalate and resolve quality issues in line with AstraZeneca SOPs. Maintain CTMS and eTMF accuracy; manage study drug supplies and accountability; and deliver clear, timely monitoring reports and follow‑up. Essential for the role Bachelor’s degree in a life science or related field (or equivalent experience). Solid understanding of the drug development process, ICH‑GCP and relevant country regulations. Experience in site selection, activation and monitoring (remote and onsite) with strong documentation discipline. Proficiency with CTMS/eTMF and data‑query management; familiarity with SDR/SDV/CRF review. Strong communication, stakeholder management and problem‑solving skills; ability to work independently and as part of a cross‑functional team. Willingness to travel for site monitoring; fluency in written and spoken business‑level English. Desirable for the role Experience across CVRM or Respiratory & Immunology trials, including multi‑country studies. Hands‑on use of RbQM analytics/dashboards to prioritise monitoring and remediation. Proven contribution to accelerated start‑up timelines and efficient site activation. Confidence in audits/inspections; track record coaching sites to readiness. Comfort with remote monitoring tools, eSource/ePRO and data‑driven decision‑making. Fluency in the local language in addition to English. 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. To Apply Please apply with a resume and cover letter outlining your suitable skills and experience applicable to this role. Where can I find out more? Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Visit our website: www.astrazeneca.com.au 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 Ready to make an impact? Apply to register your interest today. Date Posted 25-Feb-2026 Closing Date 30-Mar-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Clinical Research Associate will be responsible for owning site activation and performance, directing risk-based monitoring, and ensuring patient safety and data integrity across Biopharma and Oncology clinical trials. Key duties include identifying and evaluating sites, coordinating regulatory submissions, training site teams on compliance, and conducting remote and onsite monitoring visits.