CRA I/II

*** must have at least 1 year of independent onsite monitoring***

• 2 to 3 protocols
• 8 to 10 sites
• Sites will be local – within driving distance or a short direct flight.
• Potential to have sites in neighboring states
• Hybrid of on-site and remote monitoring.
• No on-site metrics.

• Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
• Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
• Proactive site management including:
• Building and maintaining solid and professional relationships with site staff
• Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
• Maintaining site audit/inspection readiness
• Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems
• Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
• Responding to site queries and escalating issues in accordance with processes and timelines
• Conducting IP accountability and reconciliation
• Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
• Maintenance of site study supplies