In this position I am responsible for onsite field monitoring and remote site management for Phase I-IV oncology clinical research studies. Monitoring activities are used to assess the progress of clinical studies at investigator sites to ensure trials are conducted, recorded, and reported in accordance with protocol, SOPs, ICH-GCP, and applicable regulatory requirements. Site management activities are conducted through onsite visits and remote contact to promote the success of clinical projects throughout site selection, activation, enrollment, maintenance, and close out phases.

In this position I was responsible for ensuring the safety and integrity of a variety of different genitourinary (GU) oncology trials. This included Phase I, II, and III trials examining investigational new drugs (IND) developed in the Pharmaceutical Industry and agents created by investigators at UW. Research focuses included immunotherapies, antibody conjugates, cell signaling mediators, chemotherapies, and diagnostics. • Applied knowledge of FDA, NIH-OBA, ICH-GCP and HIPAA regulations to prepare protocol-specific materials and submission to oversight bodies including IRBs, Scientific Review, IBC, Research Safety, and Conflict of Interest committees. • Simultaneously managed the implementation and conduction of multiple new and active studies. Completed new applications, continuing reviews, amendments, and reportable event/unanticipated problem, and SAE submissions. Facilitated monitor visits for industry sponsored studies.• Provided administrative support for studies using investigator INDs. Managed half a dozen studies from pilot trials to multisite phase II studies exploring the safety and efficacy of these treatments. Tracked, reported, and monitored subject status, proactively ensured compliance, and communicated with FDA, NIH-OBA, IRBs, and other applicable regulatory bodies. • Created new SOPs and office tools, and optimized existing ones, including accrual tracking tools, subject status reports, and PPOs/clinic worksheets. Worked with UWCCC collaborators and clinic staff to ensure protocol compliance and subject safety. Trained new staff on clinical research principles, UWCCC and DOWG processes, and supervised students. Served on internal UWCCC regulatory and OnCore (CMS) committees.• Data management including data entry from medical records, writing and resolving queries, remote monitoring for compliance and safety, and data extraction and processing for results to be included in manuscripts.

Membership and product sales. Account and payment reconciliation. Respond to customer inquiries and general customer service.

Managed the design, development, and testing of experiment to study the neurobiological components of sound localization. This required coordinating the use of departmental resources and ensuring effective communication amongst colleagues. For this project, as well as with other simultaneous ongoing ones within the lab, I collected, processed, and analyzed data for review. In addition, this position required regular laboratory maintenance and training of new students.