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From: 07/20/2015 07:18 0060 P.010/010 JULI C. RUBIN Created and managed multiple SOPs and training materials for regulatory and cross functional processes UNIVERSITY OF MINNESOTA, Minneapolis, Minnesota June 2004 -October 2009 Regulatory Specialist, Pediatric hematology -Oncology, November 2007 -- October 2009 Performed regulatory and clinical processes necessary to make oncology clinical trials available to childhood cancer patients per federal regulations, sponsor requirements, and University policies, • Managed reguilatory/clinical documentation and files for 30 - 35 Phase I, II, and III clinical trials, • Created and adapted consent documents in compliance with sponsor and local standards • Completed required review committee submissions on assigned protocols within strict time parameters • Reported adverse events to appropriate agencies + Served as liaison between sponsor, principal investigator, research manager, review committees and monitors (internal and external), ensuring accurate communication and compliance to regulatory, clinical, and business requirements • Led QA projects for regulatory/protocol processes and data management, and performed routine internal auditing of paper and electronic regulatory and clinical files • Developed SOPs and training materials for regulatory and departmental processes to increase efficiencies and assure compliance IT/Quality Assurance Coordinator, O"VPR/RSPP, June 2004 -November 2007 • Performed QA, problem -solving, and statistical analysis, based on federal and university regulatory and policy requirements. Analyzed, resolved, traeked and communicated system and process problems to management. • Directed problem -resolution process both internally and with other University departments. Lead team problem -solving, information sharing, and staff training • Generated statistical reports and developed models for RSPP performance, compliance and efficiencies that were utilized for management decisions, data integrity, external information requests, audit purposes and system enhancements, • Prepared compliance and project status reports for management, General Connell, and Director of Compliance, including issues or problems that impacted project schedules and recommendations • Authored and managed MB and accreditation policies and procedures, which led to full AI-IRPP re- accreditation • Developed internal database for IRB committee membership and minutes management • Managed IRE membership roster and production of complex minutes system for 7 monthly IRB committees. Led letter -writing team during documentation of committee proceedings. • Facilitated IRB and IACUC meetings and documented committee discussion and action • Composed concise, technical and detailed correspondence to investigators/researchers + Reviewed incoming correspondence designated for administrative review • Performed routine internal audits • Led study inquiries and provided guidance and problem resolution for physicians/researchers • Achieved IRB Professional certification (C1P) LEADERSHIP: • Oak hill Montessori Parents Association Board (Present) President • Medical Industry Leadership Institute Student Association (2009) VP, Internal Relations • Toastmasters, NAWBA, Netlmpaot (2007-2009) Member INTERESTS: Rock Climbing, Gardening, Theatre, Fundraising for Charity Events, and Costume Design and Construction.