Job Title: Clinical Research Associate

Location: UK-Field

Introduction to role:

Are you ready to turn cutting-edge oncology science into real patient impact by leading high-performing clinical sites to faster, higher-quality outcomes? Do you thrive at the intersection of scientific rigor, operational excellence and trusted site relationships?

As a Clinical Research Associate focused on oncology, you will be the primary link between our studies and the investigators who deliver them. You will set each site up for success, drive recruitment and data quality, and ensure inspection readiness from first-patient-in through close-out. Working alongside local study leaders and cross-functional partners, you will use risk-based approaches and modern tools to remove barriers, accelerate timelines and elevate standards of care. Your judgment at site level will directly influence pivotal milestones and the speed at which patients access innovative therapies.

Accountabilities:

• Investigator and Site Selection: Contribute to identifying and evaluating potential investigators and sites to maximize feasibility, quality and delivery.
• Study Start-up and Regulatory Readiness: In applicable countries, lead or support start-up activities including Site Qualification Visits; collect, prepare, review and track documents; and manage submissions to ethics committees/IRBs and competent authorities for both initiation and maintenance.
• Site Initiation to Close-out: Plan and conduct initiation, monitoring and close-out activities per study-specific Monitoring Plans and AstraZeneca procedures, ensuring sites deliver to commitments on time and to expected quality.
• Training and Inspection Readiness: Train, support and advise investigators and site staff on protocol, ICH-GCP and Risk Based Quality Management principles; confirm all required training is completed and documented; maintain continuous inspection readiness.
• Patient Recruitment and Site Performance: Share recruitment insights and site performance updates within the Local Study Team; proactively identify risks, remove obstacles and escalate issues appropriately to keep sites on track.
• Risk-based Monitoring and Data Quality: Perform Source Data Review, Case Report Form review, Source Data Verification and remote data checks; adapt monitoring intensity using ongoing Site Quality Risk Assessments; partner with data management to ensure robust, reliable data.
• Safety and Compliance Oversight: Ensure accurate and timely reporting of Serious Adverse Events and follow-ups; adhere to quality issue processes; uphold AstraZeneca’s Code of Ethics and comply with local, national and regional regulations.
• Systems and Documentation Excellence: Keep CTMS and other systems current; ensure timely collection and upload of essential documents into the eTMF; support and respond to QC checks; prepare all documents for final archiving.
• Investigational Product and Supplies: Manage site files, study supplies and drug accountability; oversee preparation for destruction where applicable, ensuring full compliance.
• Stakeholder Collaboration: Serve as the main contact for PIs/co-PIs and site staff; collaborate with local stakeholders such as medical science liaisons and site engagement leads; actively participate in Local Study Team meetings and contribute to national investigator forums.
• Issue Management, Audits and Inspections: Resolve site issues promptly; escalate systemic or serious quality concerns to local leadership and quality partners; prepare for and support audits and regulatory inspections in collaboration with LSAD and quality teams.
• Continuous Improvement: Share market and site intelligence; support implementation of innovative processes and technologies that improve trial delivery, quality and efficiency.
• Role Progression: With experience, take on selected responsibilities associated with Local Study Associate Director to broaden your impact.