Clinical Research Associate-208919 Jobs

Overview

• Employee is responsible for working with sites during study start up, including assessing site feasibility as required, provide ongoing training and site initiation visits, conducting remote monitoring, and approx. 25-30 interim onsite and closeout field monitoring visits located throughout the US and Canada.
• Effective long-term planning/scheduling of remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership.
• The Lead Study Monitor will be responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members.
• Effective long-term planning/scheduling of remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership.
• The CRA is expected to work cooperatively with study team and operations management to proactively drive project success.
• Responsible for all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership.
• Perform Lead Study Monitoring activities as assigned, including acting as the primary liaison between the CRO and the Clinical Study Sponsor to ensure the CRO provides quality monitoring and site management customer services.
• During each monitoring visit the CRA is responsible for the evaluation of clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPAA guidelines.
• Completes preparation and submission of accurate and timely monitoring reports, and other requested deliverables, as outlined in the Study Monitoring Plan or as requested by program leadership.