Fsp Sr Cra Level I

PPD (Thermo Fisher)

Fully remote
Neurology or oncology monitoring experience
Ich-gcp guidelines and regulatory compliance
Risk-based monitoring and root cause analysis
The role involves conducting remote or on-site visits to assess protocol compliance and manage documentation for top pharmaceutical companies

Job Summary

  • The role involves conducting remote or on-site visits to assess protocol compliance and manage documentation for top pharmaceutical companies.
  • Candidates must possess adequate neurology or oncology monitoring experience and are strongly advised to have rare disease and pediatric experience.
  • This position requires applying risk-based monitoring concepts, performing root cause analysis, and ensuring audit readiness across global trials.

Matching Summary

The role involves conducting remote or on-site visits to assess protocol compliance and manage documentation for top pharmaceutical companies.

Skills & Requirements

Must-have

  • Neurology or oncology monitoring experience
  • ICH-GCP guidelines and regulatory compliance
  • Risk-based monitoring and root cause analysis
  • Site initiation and close-out procedures
  • Remote and on-site clinical monitoring

Nice-to-have

  • Rare disease and pediatric trial experience
  • Strong critical thinking and problem-solving skills
  • Collaborative relationship building with sites
  • Experience with FSO, FSP, and Government environments
  • Effective communication with medical personnel

Key Requirements

  • Bachelor's degree in life sciences or nursing certification
  • 2+ years of clinical research monitor experience
  • Valid driver's license where applicable

Work Rights

Not specified

Tailored Resume

Cover Letter