Fsp Sr Cra I

PPD (Thermo Fisher)

Rio de Janeiro, Brazil
**
Oncology monitoring experience
Risk-based monitoring approach
Ich-gcp guidelines
** PPD (Thermo Fisher) is seeking a Senior Clinical Research Associate (Level I) in Rio de Janeiro, Brazil, to conduct clinical monitoring and site management for pharmaceutical and biotech trials. The ideal candidate should have oncology monitoring experience and a strong understanding of ICH-GCP guidelines. **

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, including remote or on-site visits to assess protocol and regulatory compliance.
  • Ensure trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability.
  • Contribute to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.

Matching Summary

Match Score: 75

** PPD (Thermo Fisher) is seeking a Senior Clinical Research Associate (Level I) in Rio de Janeiro, Brazil, to conduct clinical monitoring and site management for pharmaceutical and biotech trials. The ideal candidate should have oncology monitoring experience and a strong understanding of ICH-GCP guidelines. **

Skills & Requirements

Must-have

  • Oncology monitoring experience
  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Site processes specialist
  • Remote or on-site visits

Nice-to-have

  • Collaborative relationships with sites
  • Root-cause analysis skills
  • Problem-solving skills
  • Adaptable in wide range of scenarios

Key Requirements

  • 2+ years as a clinical research monitor
  • Bachelor's degree in life sciences or equivalent
  • Oncology monitoring experience
  • Phase I experience strongly advised

Work Rights

Not specified

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