Rebecca M. Clark, BBA, CIP 3503 Wilson Street Fairfax, VA 22030 Phone: 619-895-2535 Email: rc1ae8cc0@westpost.

net PROFESSIONAL EXPERIENCE HUMAN RESEARCH PROTECTION PROGRAM SPECIALIST | SUBJECT MATTER EXPERT Alion Science and Technology, Contractor for the Department of the Navy, Human R esearch Protection Program Washington D.C., May 2010-July 2011 Regulatory Specialist for federal regulations, DOD directives, and Navy instruct ions for human research protection. Actively monitored compliance for the DON Hu man Research Protection Program. Conducted oversight of IRB`s and HRPP`s at mult iple Navy Commands. Ensured regulatory compliance all research related activity. Organized and conducted DON HRPP assist visits and site inspections. Provided a d hoc and scheduled training sessions to Navy personnel involved in human resear ch. Monitored changes in federal, DOD and DON regulations. Updated DON HRPP and command level standards of practice to comply with regulatory changes. Accomplis hments: Developed detailed standardized reports for site inspections and assist visits that included corrective actions as well as in-depth reviews of individua l Command HRPP policies and procedures. Drafted new and revised DON HRPP policie s and guidance for inclusion in DON HRPP handbook. ASSISTANT DIRECTOR OF ACCREDITATION Association for the Accreditation of Human Research Protection Programs Washington D.C., January 2008 - April 2010 Conducted detailed analysis of regulatory compliance and AAHRPP standards for or ganizations applying for accreditation. Wrote detailed reports, both internal an d external, on each organization`s application status. Worked with multiple orga nizations to meet AAHRPP accreditation standards; provided information and guida nce; set up site visits; worked with clients during all stages of accreditation processes through final accreditation. Accomplishments: Worked with over 57 orga nizations for initial or reaccreditation. Extensive experience with Veterans Af fairs Healthcare organizations. Worked with Korean based multi-site organization through final accreditation. Mentored Korean fellows during summer internship a t AAHRPP. IRB OPERATIONS MANAGER Alvarado Hospital, April 2002 - Nov 2006; Scripps Health Hospitals, May 1992 - A ug 2006; Rady`s Children`s Hospital, Feb 1993 - Oct 2005, San Diego, CA Developed and managed the HRPP programs and served as IRB Vice Chair for all IRB s. Wrote policies and procedures, goals, and regulatory objectives. Conducted co mpliance oversight of IRBs and hospital research trials, ensuring compliancy of research protocols, informed consents, and case reports with hospital policies a nd accreditations. Provided initial review and oversight of all noncompliance/mi sconduct issues. Acted as primary reviewer for all expedited research. Wrote ann ual report on analysis of performance metrics. Conducted QA/QC and compliance re views at investigator research sites. Collaborated with hospital administrators, C-Level management, grants and contracts office, clinicians, and legal departme nts, and the Administrative Review Research Committee. Point of contact for pati ent safety and compliance to hospital staff. Accomplishments: Developed the IRB s at Scripps and Children`s Hospitals from the ground up. Created policies, form s, and systems to streamline the review process. Achieved a 97% initial IRB revi ew approval rate. Implemented a quarterly research newsletter at Children`s Hosp ital. Facilitated first Web based information site and forms distribution system . Initiated collaboration with grants office. Provided responsible conduct of re

search training.

CONSULTING Through 2011 consulted with multiple hospitals and IRBs, both hospital-based and independent. Consulting included regulatory compliance, responsible conduct of research, IRB staff and member training, workflow and streamlining the IRB proce ss. Also consulted with Infonetica, UK, on IRB software database. Additional Accomplishments Worked with multiple regulations for Dept of Defense, Dept of Veterans Affairs, Dept of Education, Dept of Energy, Dept of Justice, Environmental Protection Age ncy, Food and Drug Administration, Office of Human Research Protections, Interna tional regulations and ICH-GCP E6. Research review experience includes biomedica l, behavioral and social science research with some animal subject protection re view. Conducted annual training for IRB members to supplement CITI training and provided on-going education at IRB meetings. Developed and presented quarterly s eminar series in human research protection for investigators and their staff. EDUCATION/CERTIFICATIONS/PUBLICATION Bachelor`s Degree in Business Administration, National University, San Diego, 19 89 Certified IRB Professional Certification, 1999-2005 Drug Information Journal, Vo. 27, 1993, -Consent, Assent and Children in Researc hAFFILIATIONS, CLEARANCES AND REFERENCES Current Clearance: Secret Public Responsibility in Research and Medicine/Applied Research Ethics National Association Association of Clinical Research Professionals Drug Information Association References available upon request ADDITIONAL SKILLS Animal Subjects: Knowledgeable about and familiar with Animal Welfare Act, AAALA C accreditation standards, PHS Policy on Humane Care and Use of Laboratory Anima ls, federal regulations on IACUC`s and animal research facilities. Participated in review of animal research as it related to human research trials as IRB Vice Chair. BioSafety: Served as a non-scientific community member on the Biosafety Committe e at Clemson University. Attended NIH Workshop on issues and concerns for Biosaf ety Committees. Non-Scientific IRB Member: Independent Medical Board & Research Ethics Committe e member, contributing over 4 years of review of clinical trials, documenting co mments and suggestions as a voting member of a quorum on international clinical studies submitted to the Medical & Ethics Review Committees. Providing regulator y recommendations and support to members of the Board, Clinics, Hospitals, Compa nies and CROs of all sizes and governances. Quality & Compliance (GCP and FDA): All requirements for drugs, biologic and bio

technological products. Good Clinical Practices, clinical investigations, evalua ting and auditing clinical data for compliance, business ethics, training capaci ty and intelligence. Strong written and oral communication capacity. Language Skills: Ability to recognize, analyze and interpret federal regulations , legal documents and technical terminology. Capacity to write policies and proc edures, training materials and articles for publications in prescribed style and format and present information to top management, public and organizations. Res pond effectively to inquiries or complaints both orally and written. Communications: Implementing development cycles and mentoring staff through path s of development. Maintaining communications with internal departments, outside vendors, medical organizations, investigators and medical staffs nationwide. Imp lementing solid work strategies for new and modified medical devices and drug pr oducts from development stages to market.