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ParexelPosted 1 week ago

Senior Clinical Research Associate / Clinical Research Associate II - Oncology - West Coast US - FSP

RemoteUnited States or Remote, Oregon, United States

Full TimeSenior LevelEnterprise

Job Summary

Conduct site management, monitoring, and close-out for assigned oncology clinical trials to ensure patient safety and quality execution per GCP and sponsor standards. Serve as the primary point of contact for investigator sites, managing relationships, facilitating information flow, and providing protocol training to address site-level issues and recruitment challenges. Perform onsite and remote monitoring activities, monitor adverse events, and resolve data queries while ensuring compliance with the Study Monitoring Plan. Drive corrective and preventative actions for quality events and audit observations, support database release, and report directly to the Director of Clinical Site Operations.

Required Qualifications

  • Minimum 3 years relevant experience in clinical research site monitoring
  • 2 years in Oncology
  • Experience in a CRO or pharma organization
  • Global clinical trial experience
  • Extensive knowledge of clinical trial methodologies
  • Knowledge of ICH/GCP
  • Knowledge of Food and Drug Administration (FDA)
  • Knowledge of local country regulations
  • Fluency in English
  • Fluency in the native language(s) of the country they will work in
  • Valid driver's license
  • Passport
  • Bachelor's degree in life sciences
  • Professional degree in life sciences such as nursing, pharmacy, medical

Desired Qualifications

  • Preferred therapeutic experience in Oncology

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