Senior Clinical Research Associate

The Senior Clinical Research Associate is an important member of the Alira Health Clinical team, responsible for conducting site monitoring responsibilities for clinical trials, providing oversight, leadership, and guidance in the management and execution of clinical trials, and ensuring compliance and quality.

Requirements

• Provides guidance, oversight, and feedback to the CRA team
• Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed
• Ensures appropriate and timely investigator site visits
• Coordinates with cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
• Assists in development of study-specific Monitoring Plans and training presentations as required
• Performs qualification, initiation, interim, and close-out visits both remotely and onsite
• Ensures integrity of CRF data through meticulous and thorough source document review and verification
• Conducts investigational product accountability
• Maintains regular contact with study sites to ensure protocol/GCP compliance
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs