Ssu Cra

Syneos Health

Fully remote
Site qualification and initiation visits
Ich-gcp and regulatory compliance knowledge
Source document verification and crf accuracy
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure protocol and regulatory compliance

Job Summary

  • The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure protocol and regulatory compliance.
  • Candidates must verify informed consent processes, assess subject safety, and manage investigational product inventory and security.
  • Syneos Health offers a supportive culture focused on career development, inclusive values, and accelerating patient progress through innovative solutions.

Matching Summary

The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure protocol and regulatory compliance.

Skills & Requirements

Must-have

  • Site qualification and initiation visits
  • ICH-GCP and regulatory compliance knowledge
  • Source document verification and CRF accuracy
  • Investigator Site File maintenance and reconciliation
  • Travel up to 75% required for site visits

Nice-to-have

  • Experience with real world late phase study designs
  • Chart abstraction and data collection skills
  • Collaboration with medical science liaisons
  • Audit readiness preparation experience

Key Requirements

  • Bachelor's degree or RN in related field
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • US work authorization required for site access

Work Rights

Must be eligible for US facility access; citizenship status not explicitly defined but US only role

Tailored Resume

Cover Letter