Field-Based Clinical Research Associate

AstraZeneca

United States

Remote

USD 56,000 - 79,000

Full time

5 days ago
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Job summary

AstraZeneca is seeking a Clinical Research Associate for a field-based role in the UK. You will be the primary face of our studies at assigned sites, ensuring quality from start-up through close-out and collaborating with local study leadership and cross-functional partners.

You will train site teams, manage start-up and regulatory activities, monitor data quality and safety, and support audits while traveling nationally/internationally as required.

Qualifications

  • Bachelor degree in life science or equivalent qualification.
  • Excellent knowledge of ICH-GCP.
  • Good knowledge of local regulations related to clinical trials.
  • Experience with cell and gene therapies is advantageous.
  • Understanding of the drug development process.
  • Experience monitoring late-phase (2-4) clinical trials and data management.
  • Excellent attention to detail and communication skills.
  • Ability to travel nationally/internationally as required.

Responsibilities

  • Identify potential investigators to build a high-performing site network aligned with protocol needs.
  • Lead start-up and regulatory activities including Site Qualification Visits and regulatory submissions.
  • Train and support site staff on study requirements and risk-based quality management.
  • Participate in Local Study Team meetings and share insights to drive decisions.
  • Monitor and close study sites per Monitoring Plan; perform remote and onsite visits.
  • Perform source data verification and data quality activities.
  • Ensure timely reporting of adverse events and compliance with ethics codes.
  • Manage study supplies and drug accountability at sites; support archiving and eTMF.
  • Prepare for audits and regulatory inspections with LSAD and CQAD.
  • Provide site insights and collaborate with MSLs as directed.

Skills

ICH-GCP knowledge
Clinical trial monitoring
Communication skills
Travel willingness
Data management
Team collaboration
Drug development understanding

Education

Bachelor degree in life science

Tools

CTMS
eTMF

Job description

AstraZeneca is seeking a Clinical Research Associate for a field-based role in the UK. You will be the primary face of our studies at assigned sites, ensuring quality from start-up through close-out and collaborating with local study leadership and cross-functional partners.

You will train site teams, manage start-up and regulatory activities, monitor data quality and safety, and support audits while traveling nationally/internationally as required.

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