Cra Ii / Sr Cra - Sponsor Dedicated | Oncology | Bilingual In French And English (home-based - Montreal, Quebec, Canada)
SyneosHealth
Montreal, Quebec, Canada
Fully remote
Bilingual in french and english
Site qualification and initiation visits
Ich-gcp and gpp compliance knowledge
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance
Job Summary
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.
Syneos Health is a leading biopharmaceutical solutions organization committed to accelerating customer success and changing lives through innovative clinical development.
Candidates must demonstrate excellent communication skills and the ability to manage up to 75% travel while adapting to changing priorities.
Matching Summary
The role involves performing site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory and protocol compliance.
Skills & Requirements
Must-have
Bilingual in French and English
Site qualification and initiation visits
ICH-GCP and GPP compliance knowledge
Source document review and CRF verification
Investigator Site File maintenance
Protocol deviation assessment
Up to 75% travel requirement
Nice-to-have
Oncology therapeutic area experience
Real world late phase study designs
Chart abstraction activities
Audit readiness preparation
Patient recruitment support strategies
Training junior staff capabilities
Key Requirements
Bachelor's degree or RN in related field
Knowledge of Good Clinical Practice/ICH Guidelines
Excellent computer skills and technology adaptability