Senior Clinical Research Associate - Oncology

Posted 18 Days Ago
Be an Early Applicant
Hiring Remotely in New South Wales, AUS
Remote
Senior level
Biotech • Pharmaceutical • Manufacturing
The Role
Lead site activation and performance for oncology trials using risk-based monitoring. Conduct remote and onsite monitoring (SDR/SDV/CRF), manage EC/IRB submissions, ensure SAE reporting, maintain CTMS/eTMF and study drug accountability, train site teams on ICH‑GCP and inspection readiness, and deliver monitoring reports and remediation.
Summary Generated by Built In

We currently have a vacancy for a Clinical Research Associate in our Oncology team. This is initially a 12 Month Max Term contract position.

At AstraZeneca, we’re united by a bold ambition: to transform patients’ lives through science. Across BioPharma and Oncology, we design and deliver highquality, patientcentric 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 healthauthority submissions, secure and maintain approvals, and manage essential documents to keep studies inspectionready from day one.
  • Train and support site teams on ICHGCP 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 followup.

Essential for the role 

  • Bachelor’s degree in a life science or related field (or equivalent experience).
  • Solid understanding of the drug development process, ICHGCP and relevant country regulations.
  • Experience in site selection, activation and monitoring (remote and onsite) with strong documentation discipline.
  • Proficiency with CTMS/eTMF and dataquery management; familiarity with SDR/SDV/CRF review.
  • Strong communication, stakeholder management and problemsolving skills; ability to work independently and as part of a crossfunctional team.
  • Willingness to travel for site monitoring; fluency in written and spoken businesslevel English.

Desirable for the role 

  • Experience across CVRM or Respiratory & Immunology trials, including multicountry studies.
  • Handson use of RbQM analytics/dashboards to prioritise monitoring and remediation.
  • Proven contribution to accelerated startup timelines and efficient site activation.
  • Confidence in audits/inspections; track record coaching sites to readiness.
  • Comfort with remote monitoring tools, eSource/ePRO and datadriven decisionmaking.
  • 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

20-July-2026

Closing Date

31-July-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.

Skills Required

  • Bachelor's degree in life sciences or equivalent experience
  • Solid understanding of drug development, 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 cross-functionally
  • Willingness to travel for site monitoring; fluency in business-level English
  • 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 local language in addition to English
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The Company
90,000 Employees
Year Founded: 1999

What We Do

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company committed to excellence in the research, development, and commercialization of prescription medicines. With approximately 90,000 employees across 85 countries, the company aims to unlock the power of science to deliver innovative medicines that transform patient outcomes and improve healthcare for people, society, and the planet worldwide.

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