Oncology Clinical Research Associate: Site & Quality

AstraZeneca

Cambridge

On-site

GBP 55,000 - 85,000

Full time

4 days ago
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Job summary

AstraZeneca is seeking a Clinical Research Associate (oncology) to drive site performance and data quality from initiation through close-out. You will collaborate with investigators, site staff and cross-functional teams, ensuring regulatory readiness and inspection preparation across studies.

The role emphasizes risk-based monitoring, timely reporting of safety events, and maintaining high standards of care. A strong background in ICH-GCP and drug development is required, with travel as needed.

Qualifications

  • Bachelor’s degree in life sciences or equivalent.
  • Excellent knowledge of ICH-GCP and basic GMP/GDP.
  • Good knowledge of local regulations.
  • Solid understanding of drug development processes.
  • Strong communication and collaboration skills.
  • Ability to travel nationally/internationally as required.

Responsibilities

  • Identify and select investigators and sites to maximise feasibility, quality and delivery.
  • Lead or support start-up activities including regulatory submissions and ethics approvals.
  • Monitor sites and manage initiation to close-out per monitoring plans.
  • Ensure training and inspection readiness of site staff and investigators.
  • Support patient recruitment and monitor site performance and risk.
  • Review data quality, manage source data and maintain CTMS/eTMF accuracy.
  • Collaborate with stakeholders to resolve issues and prepare for audits and inspections.
  • Drive continuous improvement in trial delivery and data integrity.

Skills

Bachelor’s degree
ICH-GCP knowledge
Regulatory knowledge
Data management understanding
Communication skills
Travel readiness

Education

Bachelor’s degree in life sciences

Job description

AstraZeneca is seeking a Clinical Research Associate (oncology) to drive site performance and data quality from initiation through close-out. You will collaborate with investigators, site staff and cross-functional teams, ensuring regulatory readiness and inspection preparation across studies.

The role emphasizes risk-based monitoring, timely reporting of safety events, and maintaining high standards of care. A strong background in ICH-GCP and drug development is required, with travel as needed.

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