-Coordinated quality care plans for 100+ patients across multiple interagency studies-Collected and analyzed study enrollment and accrual data for oversight of study goals-Designed, developed and tested appropriate informatics tools to meet study data requirements-Submitted and maintained regulatory documentation of investigational agent administration-Determined subject population availability, developed recruitment, informed consents and screening materials and SOPs-Oversaw, assessed and ensured participant safety and strict protocol implementation/adherence-Oversaw compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs

-Developed and maintained patient databases, investigational logs and records of study treatment administration-Oversaw first line compliance for study protocol adherence-Reconciled SAE follow up documentation-Manage all data management activities of a clinical trial in the maintenance phase of the project

-Entered and analyzed preliminary data and study outcomes-Conducted standardized study procedures-Participant recruitment

-Coordinated and facilitated guide/client communication-Managed pre-season supplies-Created scheduling and SOP documents