Experienced CRA - Real World Evidence with SSU experience
IQVIA
IQVIA seeks an experienced Clinical Research Associate to manage Real World Evidence studies, combining traditional monitoring with significant site start-up and activation responsibilities. The role balances reduced on-site visits with frequent remote site management, regulatory coordination, and multi-site oversight.
Responsibilities
- Conduct site selection, initiation, monitoring and close-out visits per protocol and regulatory requirements
- Coordinate and execute site start-up activities including document collection and regulatory submissions
- Manage multiple sites simultaneously while balancing recruitment, enrollment and data quality oversight
- Track regulatory approvals, site activation milestones and maintain Trial Master File documentation
- Maintain regular remote communication with sites to ensure timely action items and milestone completion
Requirements
- Bachelor's degree in scientific, healthcare, or related field
- Minimum 1 year independent on-site monitoring experience
- Strong Site Start-Up experience including regulatory submissions and site activation
- Knowledge of GCP, ICH guidelines, and clinical research regulations
- Proficiency in Microsoft Office and clinical research systems
- Excellent organizational skills managing multiple concurrent priorities
- Strong written and verbal English communication abilities
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