Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. The Sr CRA is an important member of the Alira Health Clinical team, responsible for conducting site monitoring responsibilities for clinical trials and providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Requirements
- Provides guidance, oversight, and feedback to the CRA team
- Reviews monitoring visit reports and conducts co-monitoring and evaluation visits
- Ensures protocol compliance, addresses site questions, and assists with study recruitment, site training, and other site-related issues
- Assists in development of study-specific Monitoring Plans and training presentations
- Manages study budget and acts as referent for the sponsor for monitoring stand-alone projects
- Performs qualification, initiation, interim, and close-out visits, ensuring proper documentation of monitoring visits
- 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
- Participates in internal, client/sponsor, scientific, and other meetings as required
Benefits
- Competitive salary
- Benefits package
- Opportunities for career growth and professional development