Clinical Research Associate

ASTRAZENECA UK LIMITED; Cambridge; On-site; GBP 35,000 - 52,000; Full time

Job summary

AstraZeneca UK Limited is seeking an Oncology Clinical Research Associate to lead high‑performing clinical sites from first patient in to close-out. You will drive site selection, recruitment, data quality and inspection readiness with cross‑functional partners.

You will apply risk‑based approaches, train investigators on protocol and ICH‑GCP, manage monitoring activities, and ensure timely regulatory submissions while upholding AstraZeneca standards across international sites.

Qualifications

• Solid knowledge of ICH-GCP and GMP/GDP basics.
• Strong written and verbal communication abilities.
• Willingness to travel nationally and internationally as required.
• Good collaboration and interpersonal skills.
• Able to manage complex regulatory and site-related activities.

Responsibilities

• Identify and evaluate investigators/sites to maximise feasibility, quality and delivery.
• Lead or support study start-up activities including site qualification visits and ethics submissions.
• Plan and conduct initiation, monitoring and close-out visits per Monitoring Plans.
• Train site staff on protocol, ICH-GCP and quality management principles; ensure training completeness.
• Share recruitment insights and site performance updates with local study team.
• Perform source data verification and data checks; adjust monitoring intensity as risk is assessed.
• Ensure safety reporting and regulatory compliance; maintain inspection readiness.

Skills

ICH-GCP knowledge

Communication skills

Travel readiness

Driving licence

Team collaboration

Risk-based monitoring

Education

Bachelor's degree in life sciences

Job description

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.

• 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 accelerate 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; elevate 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.
  Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license.
• Desirable Skills/Experience:
• Ability to work in an environment of remote collaborators.
• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Familiar with risk-based monitoring approach including remote monitoring.
• Good cultural awareness.
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an enabled environment.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Why AstraZeneca:

Join a scientific community where industry and academia work side by side, bringing diverse perspectives to solve the hardest problems in cancer. You will collaborate with unexpected teams in the same room-trial physicians, statisticians, site experts and data engineers-sparking bold thinking grounded in patient outcomes. Our global reach includes hundreds of preclinical collaborations across more than 26 countries and a dedicated alliance of seven leading cancer centers, giving you unparalleled exposure and influence. We back ambition with support, valuing kindness alongside high standards, and we equip you with cutting-edge science and technology so your contribution scales from a single site to breakthroughs that touch lives worldwide. If you are ready to lead sites to higher performance and bring life-changing oncology medicines to patients faster, take the next step and shape the future of these pivotal studies with us.