In November of 2009, wrote a business plan, prepared comprehensive financials and received funding to establish a novel community based nation-wide translational research company. The primary focus of TRM is allowing community based Medical Oncologists to participate in industry sponsored clinical trials historically limited to academic and hospital centers while improving the speed and quality of study conduct to benefit all stakeholders. Requirements include establishing internal procedures for conducting business (financial, legal, marketing, policy), building relationships with clients and vendors, and instituting basic business services for each of the member physicians (financial, legal, IT services) to ensure a seamless transition that will not negatively impact patients or study sponsors. A multi-faceted professional with specific expertise including design and implementation of:• Business Plans• Financial Systems• Legal/Regulatory Systems• Human Resources• Facilities• Key Equipment• Information Technology (IT) Systems• Vendor Relationships (biopharmaceutical companies, ancillary service providers, sites, FDA, etc.)

Co-founder of novel community oncology and translational research enterprise with offices in Santa Monica and Scottsdale, AZ. Responsible for designing and implementing all operational systems; financial, legal, human resources, equipment, information technology and facilities. Identified and hired key staff for transition and expanded company from eighteen employees to over seventy-five. Oversaw the selection and installation of IT solutions designed to facilitate the conduct of business; internal office network, website, practice management, drug inventory management and pseudo-voiceover IP telephone systems. Responsible for hiring and managing teams to lease, design, supervise and construct two cancer centers; a 28,000 square foot facility in Santa Monica, California and a 38,000 square foot facility in Scottsdale Arizona. Established record of improving the speed and quality of clinical trials for over forty major international biopharmaceutical companies (client list available on request). Grew revenue by 300%.

Established one of the first “academic” Phase I Oncology Clinical Trials Program in community setting. Developed and implemented financial management system for conduct of clinical trials. Expanded the number of studies in the clinical trials program by 185%. Secured new clinical trial opportunities and successfully integrated them into practice. Oversaw regulatory aspects of clinical trials program. Educated physicians and staff regarding research responsibilities.

Responsible for protecting human subjects (military personnel and contractors) volunteering to participate in clinical trials designed to learn about potential biowarfare agents or protect military personnel from biowarfare agents in combat situations. Reorganized USAMRIID Human Use Committee to prepare for review of protocols involving biowarfare protective products prior to second gulf war. Prepared and implemented updated investigator manual, forms, etc. Prepared position paper on ethical involvement of soldiers as human subjects in research entitled, “Assessment of Use of Investigational Products in Contingency Situations or for Force Health Protection”. Presenter US Army Medical Research and Material Command: QA/QI Program Initiatives.

Founded company and recruited key management. Developed business plan, financial projections and key affiliations. Managed design of web-based application to resolve multi-tier ethics review process. Established pharmaceutical advisory board including Vice-President level corporate members. Established Institutional Review Board Advisory Group including directors at leading academic institutions. Integrated Title 21, CFR Part 11 requirements for electronic clinical trial data capture systems.

Assistant Director – Human Subjects Research• Liaison with Chancellors Office regarding human subject protection issues.• Supervised office with over 30 employees.• Established, developed and managed office budget.• Reviewed human subject protection systems and improved processes as needed.• Represented UCLA at national meetings regarding human subject research protection efforts.Assistant Director for Education• Developed Human Subjects Protection Education Program for the UCLA campus.• Made presentations to various UCLA schools and departments to educate researchers and staff regarding their ethical responsibilities when conducting human subjects research.• Supported “Re-Education” of investigators who were cited for non-compliance.• Educated IRB members regarding review responsibilities.• Supervised development of office website and educational tools.Research Network (R-Net) Process Manager• Regulatory advisor to IBM/UCLA project to streamline research process.• Developed and secured approval for use cases for various regulatory stakeholders (Radiation Safety, Human Subject Protections, Animal Care and Use, etc.).• Beta tested R-Net system software.Administrator• Recruited to address non-compliance and prevent federal action against multiple project assurance (MPA). Successfully resolved issue(s).• Established Office for Protection of Research Subjects (office previously in contracts and grants).• Expanded operations from 5 to 33 employees.• Supported design and development of new facility.• Drafted investigator’s manual and policies/procedures governing the protection of human subjects at UCLA.• Successfully supported over seven federal audits of specific studies and general human subject protection activities.• Received 5 Merit Awards for outstanding performance.

Management responsibilities for Institutional Review Board and Institutional Animal Care and Use Committees. Supervised staff and expanded operations from 2 to 4 individuals. Successfully underwent multiple audits on National Cancer Institutes (NCI) study comparing lumpectomy vs. radical mastectomy for women with breast cancer. Developed and successfully implemented study tracking system. Led effort to establish guidelines for involvement of emergency room patients as research subjects.

Police Officer responsible for routine patrol and response to emergency calls and situations. Promoted to Detective in Criminal Investigation Unit (CID). Received Unit Citation for Outstanding Performance. Received Individual Citation for Outstanding Performance.