As Leader of the Clinical Trials Office (CTO), provide management and oversight authority for all administrative, operational, financial, compliance, regulatory, and personnel business matters. ✦ Direct as many as 30 Assistant Directors and other Senior Staff, and perform over overall supervision , mentorship, and training. ✦ Additionally, maintain oversight of 200 staff at varying levels (functional directors, project managers, clinical research supervisors, clinical and regulatory coordinators, and budget/finance administrators). ✦ Spearheaded a financial overhaul, transforming a $5.3M deficit into a $2M surplus by conducting a thorough needs assessment, and by implementing accurate forecasting models -- all within a 12-month period. ✦ As Senior Administrator, oversee all NCI CCSG submissions and presentations. ✦ Manage the administrative coordination of key Committees, including Protocol Review & Monitoring and Data & Safety Monitoring. ✦ As owner of a $24M annual budget, ensure a robust clinical trials structure (over 400 total trials, 150 active) and a service-oriented CTO. ✦ Collaborate with senior leaders to develop divisional budgets and other fiscal controls. ✦ Foster strategic relationships with biotech and pharmaceutical companies to improve and expand clinical trial options for UCSD patients. ✦ Plan and host various symposia and networking events, and by engaging physician leaders. ✦ Continually evaluate staffing metrics and space utilization to maximize limited existing resources. ✦ Initiated and led an office-wide re-organization and process improvement, thereby reducing staff turnover rate from 38% to 8%. ✦ Subsequently created a reduction in timeline to activation by 60%, and increased patient accrual by 33% within a six-month period. ✦ Significantly enhanced staff work experience by developing training, supervision, mentoring, and performance standards.

Project Manager for Experimental Therapeutics (Phase 1 Immunotherapy and Genomics) and Gastrointestinal/Colorectal TeamsProject managed investigator-initiated and industry-sponsored clinical trials for all Phases treating patients with advanced illness, overseeing site selection, drug supply forecasting, and qualification at a national and global level. ✦ Coordinated, curated and chaired periodic disease team meetings. ✦ Supervised Clinical Trial Coordinators, Regulatory Associates, and Junior Project Managers, and conducted every aspect of staff hiring, training, and review. ✦ Collaborated closely with PI’s to develop trial protocols, create CRFs, and perform internal monitoring. ✦ Invited to design and create a first-ever Phase I Team, resulting in a dramatic increase in trials from two to more than 40. ✦ As the primary liaison between industry partners and the Center, developed new study processes and protocols. ✦ Using Epic SlicerDicer, evaluated the feasibility and recruitment goals for oncology clinical trials. ✦ Developed and negotiated trial-specific budgets and contract payment terms, consistent with Medicare guidelines ✦ In close association with physicians, developed and edited successful grant proposals and publication submissions.

Coordinated trials in the fields of pediatric food allergies, pediatric ICU drug therapy dosage, diabetes, and mitochondrial disease. ✦ Managed every aspect of study subject engagement, including building trusting relationships with patients up to 18 years old, and including their parents. ✦ Ensured strict compliance with all GCP, ICH, and FDA regulatory guidelines. ✦ Developed, wrote, and edited numerous key documents, including new protocol applications, amendments, informed consent forms, safety reports, and other ancillary documents as needed. ✦ Negotiated budgets with study sponsors to ensure adequate study funding. ✦ Served as liaison between Principal Investigators, the IRB, and study sponsors.

Maintained, managed, and coordinated all aspects of regulatory compliance for 12 Primary Investigators’ research. ✦ Evaluated and monitored protocol compliance to ICH and GCP guidelines. ✦ Prepared and verified submission of protocol revisions, safety reports, and continuing reviews to the IRB. ✦ Verified patient eligibility. ✦ Maintained trial master files for multiple-site studies. ✦ Organized and managed study sponsor monitoring visits. ✦ Trained new team members on processes and protocols.

• Recruited and screened subjects for the “Attitudes Toward HPV Vaccination in Males” study from an adolescent outpatient clinic in a low-income, urban hospital based on ICH policies.• Performed semi-structured qualitative and quantitative interviews, transcribed audio recordings of interviews, and maintained study data per IRB guidelines. Coded transcriptions, performed literature searches, created presentation materials, and drafted manuscripts for a publication in Clinical Pediatrics.

Organized and maintained files for two research studies investigating asthma studies in homes.Entered data into the Epi Info program from hard copiesFound and corrected database discrepancies

Organized and filed Massachusetts hospital emergency contraception and sexual assault emergency department policies.Tracked and assessed compliance and communication for emergency contraception access.Developed a score sheet for area hospital compliance to policies and regulations.

• Performed data entry, administrative tasks, developed experiment protocols, wrote application notes, and recorded procedures following standard operating procedures and FDA policies.• Prepared blood and cell samples and ran analysis experiments related to HIV, cancers, and rare blood diseases using BD flow cytometers and FACS DIVA, FCS Express, and Microsoft office software.• Produced progress reports regarding product development and experiments and assisted in manuscript preparation.

Researched, proof-read and cross-referenced Nevada demographic health data by county.Formulated and updated data tables in Excel and WordPerfect.Developed and prepared the 2009 Nevada Rural and Frontier Health Data Book.