Senior Clinical Research Associate

4h4 hours ago

AstraZeneca

AU · Full-time · A$110,000 – A$130,000

About this role

We are building out our Oncology team and have two vacancies for Clinical Research Associates available now. At AstraZeneca, we design and deliver high-quality, patient-centric clinical trials that translate deep biology into breakthrough medicines.

As a Clinical Research Associate, you will own site activation and performance, direct risk-based monitoring to 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.

You will collaborate with cross-functional teams across BioPharma and Oncology, embedding compliance routines and coaching site teams toward audit readiness. Our inclusive culture champions diversity and supports lifelong learning and growth.

At AstraZeneca, you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There is no better place to make a difference to medicine, patients, and society as we pioneer the future of healthcare.

Requirements

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.

Responsibilities

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 risk-based quality management (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.

Benefits

Empowered to push the boundaries of science and unleash your entrepreneurial spirit.
Inclusive culture that champions diversity and collaboration.
Committed to lifelong learning, growth and development.
Opportunity to pioneer the future of healthcare and make a difference to medicine, patients, and society.