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Clinical Research Associate I/II

2 months ago

Florida, United States ICON Strategic Solutions Full time

*** Minimum of 1 year of independent on-site monitoring experience required ***

As a Clinical Research Associate I/II at ICON Strategic Solutions, you will play a pivotal role in the management of clinical trials. Your responsibilities will include:

  • Managing 2 to 3 clinical protocols
  • Overseeing 8 to 10 clinical trial sites
  • Conducting visits to local sites, which may include short direct flights to neighboring states
  • Utilizing a hybrid approach of on-site and remote monitoring
  • Ensuring that no on-site metrics are required
  • Performing comprehensive site evaluations, initiations, monitoring, and close-out visits
  • Overseeing and documenting the execution of clinical trials at the site level, including online visit reports and updates to electronic management systems
  • Engaging in proactive site management by:
    • Establishing and nurturing professional relationships with site personnel
    • Implementing subject recruitment strategies and action plans at the site level
    • Maintaining readiness for audits and inspections
    • Ensuring accurate safety reporting and utilizing online safety reporting systems
    • Verifying electronic case report form data against source documentation as per study protocols
    • Addressing site inquiries and escalating issues according to established processes
    • Conducting accountability and reconciliation of investigational products
    • Facilitating the adoption of new technologies and systems at clinical sites, such as Electronic Data Capture and eSAE reporting
    • Managing the supply of study materials at the site