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

AstraZeneca

Osaka, Japan
On-site
Monitor clinical trials
Ensure gcp compliance
Site selection and monitoring
AstraZeneca is seeking a Senior Clinical Research Associate (CRA) or Clinical Research Associate (CRA) for its Late Development Oncology Clinical Operations team in Osaka or Tokyo, Japan. The role involves monitoring clinical trials to ensure compliance with protocols, protecting human subjects, and maintaining data integrity while leading and mentoring other CRAs

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 line of communication between the sponsor and investigator, managing and monitoring sites, and ensuring inspection readiness of TMF.
  • Senior CRA responsibilities include leading a number of CRAs, taking delegated tasks from Study Leaders, contributing to Clinical Operations Japan development, and mentoring CRAs.

Matching Summary

Match Score: 85

AstraZeneca is seeking a Senior Clinical Research Associate (CRA) or Clinical Research Associate (CRA) for its Late Development Oncology Clinical Operations team in Osaka or Tokyo, Japan. The role involves monitoring clinical trials to ensure compliance with protocols, protecting human subjects, and maintaining data integrity while leading and mentoring other CRAs.

Skills & Requirements

Must-have

  • Monitor clinical trials
  • Ensure GCP compliance
  • Site selection and monitoring
  • Communication between sponsor and investigator
  • Manage site quality and timelines
  • Inspection ready TMF

Nice-to-have

  • Collaborate with external partners
  • Lead CRAs
  • Mentor CRAs
  • Contribute to process development

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), preferably in biological science or discipline associated with clinical research
  • Communication skill
  • Negotiation skill
  • Spirit of inquiry
  • Ability to manage clinical study data delivery
  • Ability to plan effective monitoring activity
  • Ability to build and manage effective relationship with Investigators and site staff
  • Drives Accountability
  • Works Collaboratively
  • Demonstrate superior site monitoring and management skills
  • Examine issue signals and resolve them
  • Effective problem and conflict resolution skills
  • Ability to share best practice and lessons learnt
  • Ability to build and manage effective relationship with CRO

Work Rights

Not specified

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