Tyree M.

Senior Clinical Research Associate @Rho

Conduct pre-study site (selection) visits and study initiation visits to review the adequacy of the study site to conduct a clinical trial. Provide verbal and written feedback to study sites regarding overall performance, deficiencies, and overall performance. Prepare monitoring visit reports and communicate findings to site personnel, the Rho Clinical Operations management, and the Rho Project Manager. Conduct business in accordance with FDA regulations, ICH/GCP guidelines, and sponsor requirements. Review regulatory documents internally and on-site to ensure compliance with FDA regulations and guidelines. Ensure high performance and efficiency of the clinical team through trip report review, co-monitoring, and ongoing mentoring of the CRA team.