Clinical Research Associate

Job Title: Clinical Research Associate

Location: UK -  Field-based,

Introduction to role:

As a Clinical Research Associate, you will be the primary face of our studies at assigned sites, ensuring excellence from start-up through close-out. You will collaborate closely with local study leadership and cross-functional partners to uphold the highest standards of quality, compliance and patient safety. Your work will directly influence trial timelines, data integrity and the speed at which new therapies move forward.

In this role, you will bring structure and momentum to complex studies training and guiding site teams, leveraging risk-based approaches, and translating insights from the field into action. You will join a community that pairs scientific rigor with digital and data driven tools, all in service of delivering life-changing medicines to people who need them most.

Accountabilities:

• Contribute to identifying and assessing potential investigators to build a high-performing site network aligned with protocol needs and patient access.
• lead start-up and regulatory maintenance including Site Qualification Visits; collection, preparation, review and tracking of documents; and submissions to EC/IRB and Regulatory Authorities for study start-up and throughout the study.
• Train, support and advise Investigators and site staff on study-specific requirements and Risk Based Quality Management principles; confirm completion and documentation of required training, including ICH-GCP; keep sites inspection-ready at all times.
• Actively participate in Local Study Team meetings and contribute to National Investigators meetings as applicable; share recruitment and site performance insights to drive data-informed decisions and actions.
• Initiate, monitor and close study sites in line with AstraZeneca Procedural Documents and the study-specific Monitoring Plan; perform remote and onsite visits and remote data checks; collaborate with LSAD on visit timing and type when required.
• Perform Source Data Review, Case Report Form review and Source Data Verification per the Monitoring Plan; conduct regular Site Quality Risk Assessments and adapt monitoring intensity accordingly; ensure timely data query resolution and partner with data management to drive robust data quality.
• Ensure accurate and timely reporting of Serious Adverse Events and follow-ups; escalate systematic or serious quality issues, data privacy breaches and CSP or ICH-GCP compliance issues per local processes; ensure compliance with the Code of Ethics, company policies (including SHE) and local/national/regional legislation.
• Manage study supplies, drug supplies and drug accountability at sites; prepare study drug for destruction where applicable.