Fsp Cra (level Ii)

PPD (Thermo Fisher)

Shanghai, China
On-site
Conduct remote or on-site visits
Assess protocol and regulatory compliance
Manage required documentation
PPD (Thermo Fisher) is seeking a Clinical Research Associate (Level II) in Shanghai, China, to manage clinical monitoring and site management processes. The role involves conducting on-site and remote visits to ensure compliance with protocols and regulations while fostering relationships with investigational sites

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring subjects' rights, well-being, and data reliability.
  • Conduct remote or on-site visits to assess protocol and regulatory compliance, manage documentation, and ensure audit readiness.
  • Utilize risk-based monitoring, root cause analysis, and critical thinking to identify site process failures and implement corrective actions.

Matching Summary

Match Score: 85

PPD (Thermo Fisher) is seeking a Clinical Research Associate (Level II) in Shanghai, China, to manage clinical monitoring and site management processes. The role involves conducting on-site and remote visits to ensure compliance with protocols and regulations while fostering relationships with investigational sites.

Skills & Requirements

Must-have

  • Conduct remote or on-site visits
  • Assess protocol and regulatory compliance
  • Manage required documentation
  • Ensure ICH-GCP guidelines adherence
  • Risk-based monitoring approach
  • Root cause analysis (RCA)
  • Investigational product assessment

Nice-to-have

  • Develop collaborative relationships with sites
  • Contribute to project team initiatives
  • Maintain customer focus
  • Flexible and adaptable in scenarios

Key Requirements

  • Bachelor's degree in life sciences or equivalent
  • 1 year clinical research monitor experience
  • Valid driver's license where applicable

Work Rights

Not specified

Tailored Resume

Cover Letter