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 and 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
• Performs qualification, initiation, interim, and close-out visits, ensuring proper documentation of monitoring visits
• Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
• Ensures integrity of CRF data through meticulous and thorough source document review and verification
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance