【astrazeneca】【r&d】senior Clinical Research Associate / Clinical Research Associate(oncology), Development Operations, Late Development Oncology Clinical Operation 2

astrazeneca

Osaka, Japan
Site selection activities
Monitor trial conduct
Ensure data accuracy
Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out activities to verify subject rights, data accuracy, and compliance with protocol, GCP, and regulatory requirements

Job Summary

  • Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out activities to verify subject rights, data accuracy, and compliance with protocol, GCP, and regulatory requirements.
  • Key responsibilities include acting as the main communication line, managing and monitoring sites, participating in meetings, cooperating with audits and inspections, and ensuring inspection-ready TMF.
  • Senior CRA responsibilities include leading CRAs, contributing to Clinical Operations development, and mentoring CRAs on monitoring and internal procedures.

Matching Summary

Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out activities to verify subject rights, data accuracy, and compliance with protocol, GCP, and regulatory requirements.

Skills & Requirements

Must-have

  • Site selection activities
  • Monitor trial conduct
  • Ensure data accuracy
  • Compliance with GCP
  • Communication between sponsor and investigator

Nice-to-have

  • Collaborate with external partners
  • Share best practices
  • Mentor CRAs

Key Requirements

  • At least 3 years of CRA experience
  • Demonstrated leadership capability
  • Negotiated complicated issues with site staff
  • Team oriented and flexible
  • Bachelor’s degree (or equivalent) in biological science or clinical research discipline

Work Rights

Not specified

Tailored Resume

Cover Letter