Responsible for successfully performing site monitoring and site management activities
Conducts site visits on-site and remotely to confirm initial and ongoing site suitability and to assess study conduct
Follows study-specific site monitoring plans to assess and support sites’ compliance with the protocol, data quality, and participant safety
Develops and sends confirmation and follow-up letters to provide clear communications with sites
Completes initial and ongoing study training; delivers and documents relevant study training with site personnel
Partners with RBQM Operations to address centralized monitoring findings with sites
Conducts Monitoring Oversight Visits to assess site monitoring quality and/or resolve issues in site data quality or site monitoring quality

Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
Minimum of 5 years of experience in Site Monitoring / Site Monitoring Management, or Risk Based Monitoring roles with Sponsors or CROs
Robust understanding of the drug development and clinical trial execution processes
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)
Experience successfully delivering site monitoring and risk-based monitoring, including onsite and remote monitoring models
Experience in navigating external vendor portals / reports, and knowledge of Veeva EDC, TMF, and CTMS

Senior Clinical Research Associate

Key skills