Cra Ii - Fsp - Homebased In Romania

Syneos Health

Remote, , Romania
Fully remote
Ich-gcp and regulatory compliance
Clinical site monitoring and management
Remote and on-site clinical study support
Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success and improving patient outcomes

Job Summary

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success and improving patient outcomes.
  • The CRA II role involves comprehensive clinical site management activities including monitoring, data verification, investigational product oversight, and ensuring adherence to ICH-GCP and regulatory standards.
  • The company fosters a Total Self culture promoting diversity, career development, and a supportive work environment with opportunities for global collaboration.

Matching Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success and improving patient outcomes.

Skills & Requirements

Must-have

  • ICH-GCP and regulatory compliance
  • Clinical site monitoring and management
  • Remote and on-site clinical study support
  • Data verification and query resolution
  • Investigational product handling and reconciliation
  • Subject safety and protocol compliance assessment
  • Use of electronic data capture systems

Nice-to-have

  • Strong communication and interpersonal skills
  • Adaptability to changing priorities
  • Collaboration with cross-functional teams
  • Support for audit readiness and training
  • Proactive site identification and recruitment support
  • Experience with Real World Late Phase studies

Key Requirements

  • Bachelor’s degree or RN in related field
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • Ability to manage up to 75% travel
  • Experience with clinical monitoring and site management
  • Compliance with site access medical and personal information requirements

Work Rights

Not specified

Tailored Resume

Cover Letter