AstraZeneca
Biopharma
ClinicalResearchAssociate
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Associate at AstraZeneca. Skills: Site activation, Risk-based monitoring, Patient safety, Data integrity. Own site activation. Own site performance”
What You'll Achieve.
Accelerate launches
Industry & Context.
Problem-solving ability
Willingness to travel
What They're Looking For.
Must Have
Bachelor's degree in life science, Solid understanding of drug development, Experience in site selection, Proficiency with CTMS/eTMF, Familiarity with SDR/SDV/CRF review, Communication skills, Stakeholder management skills, Problem-solving ability, Work independently, Work as part of a team, Willingness to travel, Business-level English fluency
Nice to Have
Experience across CVRM trials, Experience across Respiratory & Immunology trials, Experience with multi-country studies, Hands-on use of RbQM analytics, Proven contribution to accelerated start-up, Confidence in audits/inspections, Track record coaching sites, Comfort with remote monitoring tools, Comfort with eSource/ePRO, Comfort with data-driven decision-making
What You'll Do.
Direct risk-based monitoring
Safeguard patient safety
Safeguard data integrity
Partner with investigators
Shape inspection readiness
Apply forward-looking approach
Build collaborative relationships
Drive sustained performance
Coordinate EC/IRB submissions
Coordinate health-authority submissions
Manage essential documents
Keep studies inspection-ready
Embed compliance routines
Coach toward audit readiness
Coach toward inspection readiness
Conduct remote monitoring
Conduct onsite monitoring
Perform Source Data Review
Perform Source Data Verification
Adjust monitoring intensity
Ensure timely reporting
Report Serious Adverse Events
Identify quality issues
Escalate quality issues
Resolve quality issues
Manage study drug supplies
Deliver clear monitoring reports
Deliver timely monitoring reports
How You'll Work.
Team & Collaboration
Cross-functional team
Communication Scope
Written English; Spoken English
Full Job Description
We are actively building a talent pipeline for **Clinical Research Associate** positions within our Biopharma and Oncology teams in Sydney, with recruitment anticipated later in 2026. If you’d like to be among the first to hear about these upcoming roles, we invite you to join our Talent Network. By registering, you’ll gain access to early notifications of vacancies, networking opportunities, and tailored insights to support your career development. Stay connected with us and secure your chance to be part of our future hiring initiatives. 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 monit
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