Clinical Research Associate - Cell & Gene Therapy

AstraZeneca plc; United Kingdom; Remote; GBP 42,000 - 56,000; Full time

Job summary

AstraZeneca plc is seeking a Clinical Research Associate to oversee sites for cell and gene therapy studies in the UK. You will drive start-up, regulatory submissions, and ongoing QC to ensure data integrity and patient safety.

You will train investigators, monitor sites with risk-based approaches, manage CTMS/eT MF updates, and collaborate with MSLs and LSAD. Travel nationally/internationally is required.

Qualifications

• Bachelor degree in life sciences or related discipline; equivalent qualification.

Responsibilities

• Act as primary face of studies at assigned sites from start-up to close-out.
• Train and guide site teams on study requirements and quality management.
• Identify investigators and build a high-performing site network.
• Lead start-up activities and regulatory maintenance (EC/IRB submissions).
• Ensure timely reporting of Serious Adverse Events and regulatory compliance.
• Update CTMS and eTMF; prepare monitoring visit reports and follow-ups.
• Collaborate with local MSLs and LSAD; participate in study team meetings.
• Travel nationally/internationally as required to monitor sites.

Skills

ICH-GCP knowledge

Cell & gene therapies

Drug development process understanding

Clinical trial monitoring (late phases

Attention to detail

Written & verbal communication

Collaboration & interpersonal skills

Travel nationally/internationally

Risk-based monitoring

Remote collaboration

Education

Bachelor degree in life sciences or related discipline

Job description

AstraZeneca plc is seeking a Clinical Research Associate to oversee sites for cell and gene therapy studies in the UK. You will drive start-up, regulatory submissions, and ongoing QC to ensure data integrity and patient safety.

You will train investigators, monitor sites with risk-based approaches, manage CTMS/eT MF updates, and collaborate with MSLs and LSAD. Travel nationally/internationally is required.