SUMMARY OF EXPERIENCE: CRA Linda Hood, Principal/Sr. Clinical Research Associate Over 25 years in clinical monitoring as a Senior Clinical Research Associate in large global/multi-national studies (phase I, phase II and III). I completed courses and degree pending for Master of Science in Applied Clinical Research. I hold a B.S. in biochemistry and chemistry. I successfully completed one year of medical school in Internal Medicine and Infectious Diseases and a six-month residency program in Clinical AIDS Research. My clinical research career has included Phase I-IV clinical trials in many therapeutic areas. I monitored numerous pharmaceutical clinical sites and trained site staff both nationally and internationally. I have knowledge of regulatory, compliance, and submission requirements for conducting clinical trials in Australia, Brazil, Canada, China, EU, India, and Russia. I have monitored up to fifteen multi-national trials across up to 41 countries with approximately 2000 patients enrolled. Additionally, I have developed strategies for conducting closedown visits and have managed U.S. and international clinical research associates. I have over 18 years of recent oncology clinical studies site management experience. As a Trained Clinical AIDS Counselor in California, I taught AIDS education at several colleges and received numerous awards for teaching. Since 2000, my knowledge and expertise of electronic data capture (EDC) has been utilized by several companies. Study Manager With 2 years of study management experience that includes management of multi-national studies, oversight of Contract Research Organization CRAs to ensure completion of trip reports in a timely manner, Responsible for conducting clinical studies, including participating in writing study protocols, amendments, and administrative changes based on the approved synopsis in collaboration with the Program Manager and other functional groups including Clinical Science according to TGRD SOPs and ICH, GCP guidelines and required regional regulations as applicable, ensured training of all cross-functional team members, Site Operations, and vendors on the protocol and on expectations of the study, and responsible for managing assigned study (ies) within budget provides latest best estimate of study budget according to sponsor processes provides guidance to study team on changes to study budget. Achieved an FDA submission successfully, which led to drug approval. Serve * Provided monitoring visits and site management for a variety of oncology protocols that are complex and/or require knowledge in advanced oncology clinical research. * Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits liaise with vendors and other duties, as assigned * Prepare accurate and timely trip reports * Manage small projects under direction of a Project Manager/Director as assigned Linda J. Hood 1264 Kenilworth Drive (651) 739-0200 as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned Assisted * Responsible for 24 oncology study sites * Responsible for 100% drug reconciliation for all sites covering 6 protocols Linda J. Hood 1264 Kenilworth Drive (651) 739-0200 other regional CRAs with 100% SDV monitoring and regulatory reconciliation * Conducted source data verification as required to data monitoring guidelines * Maintained awareness of local regulatory requirements and to conducted studies in accordance with IPC Responsible for * Site Manager for two Schedule II opioid narcotic drug studies used to assess the efficacy of treatment of subjects with severe and chronic back pain Linda J. Hood 1264 Kenilworth Drive (651) 739-0200 site monitoring and closeout for these studies which included sole responsibility for monitoring 12 sites ten of which included two different Schedule II studies * Performed closeout for these studies which required ensuring that each DEA 222 Form was complete and accurate prior to submitting returned study drugs to the local DEA offices Managed clinical trials * Established in-house training course for monitoring US and international oncology clinical trials * Conducted in-house audits, prepared revisions to protocols, and reviewed detailed reports of audit results Linda J. Hood 1264 Kenilworth Drive (651) 739-0200 successfully participated in implementing (Phase I through Phase IV) clinical trials used to develop nutritional and sports supplements * Skilled in the development and writing of clinical protocols consents CRFs and SOPs. Initiated monitored and managed clinical trials

Highlights:

• Compliance
• Documentation
• Clinical Research
• Management
• Query
• Research
• Audit
• Cancer
• Project Management
• Project Manager