Steven B. Fouts

UBC

08.2013 - Current

Conducted selection, initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Managed project risk by identifying, quantifying and monitoring potential threats.
Thorough knowledge and application of project specific protocol
Consistently completes on site monitoring in accordance with project specific timelines
Consistently completes travel scheduling in accordance with project specific guidelines
Attends project team meetings, department meetings and minimum of monthly 1:1 with manager; responsible for content of these meetings
Consistently completes site monitoring reports, confirmation/follow-up letters per client SOPs
Ensures follow-up of site issues and action items per sponsor timelines
Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
Ensures completion of Call Log or Telephone Contact Report detailing communication with sites per protocol
Monitors within EDC data entry, if applicable, and assists sites with DCF resolution
Completes Regulatory Binder and Investigational Product reconciliation
Maintains regular contact with assigned sites per study requirements
Consistently completes SOP review and documentation within requested timelines
Consistently completes sponsor specific training and documentation within requested timelines