Anda di halaman 1dari 6

Kevin Lee Nellis, MS, MT (ASCP) 309 West 85th Street, Apt.

# 41 New York, NY 10024 1169 6th St NE Washington, DC 20002 Mobile: (202) 262-9053 Work: (202) 443-5654 Home E-mail: kn1389f92@westpost.net Work E-mail: Kevin.Nellis@va.gov HIGHLIGHTS OF QUALIFICATIONS: * Expert in regulatory compliance * Five years providing regulatory guidance and oversight in the protections of h uman subjects * Knowledgeable with 45 CFR 46, 38 CFR 16, 21 CFR parts 50, 56, 312, and 812; FD A's principles of Good Clinical Practices, FDA's Current Good Manufacturing Prac tices, HIPAA Privacy and Security, HITECH, Privacy Act, JCAHO, CAP, and AAHRPP, and VA/VHA Policy * Demonstrated assessment of human research protection programs * Experienced with developing and implementing policies, guidance, and standard operating procedures (SOPs) * Strong training and curricular development experience * Twenty four years clinical-research experience * Fourteen years of management and supervisory experience * Managed up to 147 FTE across 16 sections at the National Cancer Institute * Clinical knowledge in Clinical and Anatomic Pathology EDUCATION: Master of Science in Applied Management (May 2001) University of Maryland University College, Adelphi, Maryland Bachelor of Science in Medical Technology (May 1987) University of Texas Health Science Center & University of Texas at San Antonio ( Joint Degree), San Antonio, Texas Judson High School (May 1982) Converse, Texas CERTIFICATIONS: Joseph P. and Rose F. Kennedy Institute of Ethics Intensive Bioethics (2008) Georgetown University, Washington, DC Excellence in Government Fellows Program (2004) Council for Excellence in Government, Washington, DC Medical Technologist [MT (ASCP)] (1987) American Society of Clinical Pathologists RECENT RELEVENT PROFESSIONAL EXPERIENCE:

U.S. Department of Veterans Affairs Program for Research Integrity Development & Education (PRIDE) Washington, DC 12/2009 to present Program Analyst *Regulatory Advisor (non-voting member) for the VA Central Institutional Review Board (IRB). *Provide effective guidance and policy to 110 Veterans Affairs Medical Centers c onducting to ensure compliance with human research regulations ethical conduct o f research. *Apply knowledgeable of 45 CFR 46, 38 CFR 16, 21 CFR parts 50, 56, 312, and 812; and VA/VHA Policy, and AAHRPP standards. *Provide ongoing training to VA staff, including investigators and members of th e IRBs, on human subjects protections. *Answer inquires from IRB staff, researchers, and compliance officers.*Review ne w IRB protocol applications files (~40 new protocols per year that yield about ~ 300 local site applications) for the VA Central IRB. *Assist VA Central IRB with analysis of complaints, compliance reports, adverse events, and unanticipated problems *Audit and evaluate the human subjects protection programs to address non-compli ance, weaknesses in programs, and to provide policy recommendations for performa nce improvement. *Promote and ensure AAHRPP accreditation of IRBs within VA system. *Enhance high ethical standards within the VA culture in concert with the nation al strategic plan and the VA's National Center for Ethics in Health Care. U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) Rockville, Maryland 11/2006-12/2009 Public Health Analyst *Provided expert guidance on Title 45 CFR part 46 and human subjects research et hics to investigators, IRB staff on a global basis. *Provide training and education involving the protection of human subjects to in dividuals attending national. conferences, OHRP workshops, or by special request s. *Experience with evaluating programs as a part of not for cause site audits. *Conducted quality improvement evaluations of Human Research Protection Programs . *Develop educational activities, materials, and presentations and conferences. *Communicated with IRB staff and investigators at varying institutions as a resu lt of contacting OHRP for assistance. * Worked with OHRP staff in formulating responses. National Cancer Institute Laboratory of Pathology Bethesda, Maryland 7/2000 - 11/2006 Clinical Laboratory Manager *Managed 147 FTEs in 16 clinical-research labs to support NIH trials. *Evaluated and implemented changes for optimal quality of patient care. *Assessed operations associated with research to further support and improve bio medical and social behavioral research, including improving the quality of the l aboratories, and obtaining CAP and JCAHO certification. *Developed programs in safety and requesting biological materials. *Assessed and revised policies related to regulatory and accreditation complianc e. *Responsible for oversight of ~$16 million budget, including procurement, purcha sing, supply transport, and services. *Oversaw renovations and capital equipment improvements. *Familiar with IACUC regulations and animal safety.

University of Maryland Medical Systems Laboratory Medicine Baltimore, Maryland 8/1996 - 6/2000 Technical Coordinator *Maintained regulatory compliance with CAP, JCAHO, laboratory safety, patient sa fety, and patient billing for all sections of the laboratory. *Developed a program to monitor daily billing practices and correct technical is sues with billing and patient registrations to correct rejected charges. *Active in process improvement, satisfaction, and marketing. *Budget oversight. *Managed capital improvement projects that involved equipment purchases and reno vations. University of Maryland Medical Systems Molecular Diagnostics Laboratory Baltimore, Maryland 9/1994 - 8/1996 Diagnostic Development Manager *Established and managed a new molecular diagnostic laboratory. *Developed and validated clinical DNA & RNA tests for hematopathology, infectiou s disease, and genetic disorders. *Developed and supervised an excellent team of 8 full time employees. University of Texas, M.D. Anderson Cancer Center Bone Marrow Transplant Laboratory Houston, Texas 10/1992 - 8/1994 Assistant Chief Medical Technologist (10/1993 - 8/1994) Medical Technologist Supervisor (10/1992 - 10/1993) *Converted research operations into a clinical laboratory. *Performed technical procedures related to bone marrow harvest, processing, purg ing, storage, and transplant. *Assisted with development of a performance appraisal system. *Supervised staff of 5 bone marrow processing scientists. *Converted research operations in to a clinical laboratory. University of Texas, M.D. Anderson Cancer Center Molecular Diagnostic Laboratory Houston, Texas 10/1987 - 10/1992 Medical Technologist Supervisor (10/1989 - 10/1992) Medical Technologist (10/1987 - 10/1989) *Established M.D. Anderson's first molecular diagnostics lab. *Supervised staff of 6 Medical Technologists and 2 secretaries. *Developed technical procedures for molecular testing of hematological malignanc ies and bone marrow chimeras.

PRESENTATIONS: *Developing IRB Meeting Minutes. National Association of IRB Leaders (April 28, 2011, Atlanta, GA). *HRPP 201 Case Studies: Exempt Research and Expedited Review. Veterans Affairs Human Research Protection Program 201 Training (March 24, Orlando, FL). *Beyond the Basics of IRB Review. Veterans Affairs Human Research Protection Pr

ogram 201 Training (March 23, Orlando, FL). *Recognizing and Minimizing Risks in VA Research. Veterans Affairs Human Resear ch Protection Program 201 Training (March 23, Orlando, FL). *VA Central IRB Determinations: Exemptions & Engagement of Institutions in Human Subjects Research. VA Central IRB Training Day (January 31, 2011, Washington, DC). *Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review. VA SimLEARN Library (February 2011, posted online) *Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review. Veterans Affairs Human Research Protection Program 101 Training (Januar y 25-26, 2011, Salt Lake City, UT). *IRB Meeting Minutes & Records. Veterans Affairs Human Research Protection Progr am 101 Training (January 25-26, 2011, Salt Lake City, UT). *Continuing Review. Veterans Affairs Human Research Protection Program 101 Trai ning (January 25-26, 2011, Salt Lake City, UT). *Legally Effective Informed Consent. Veterans Affairs Human Research Protection Program 101 Training (January 25-26, 2011, Salt Lake City, UT). *Vulnerable Populations. Veterans Affairs Human Research Protection Program 101 Training (January 25-26, 2011, Salt Lake City, UT). *What's New in the VA Human Research Protections? PRIM&R Advancing Ethical Resea rch Conference (December 8, 2010). *Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review. Topics in Veterans Affairs Research for IRB and R&D Committee Members ( October 26-29, 2011, San Juan, PR). *Informed Consent. Topics in Veterans Affairs Research for IRB and R&D Committe e Members (October 26-29, 2011, San Juan, PR). *Principal Investigator Responsibilities. Topics in Veterans Affairs Research f or IRB and R&D Committee Members (October 26-29, 2011, San Juan, PR). *Vulnerable Populations. Topics in Veterans Affairs Research for IRB and R&D Co mmittee Members (October 26-29, 2011, San Juan, PR). *Continuing Review. Topics in Veterans Affairs Research for IRB and R&D Committ ee Members (October 26-29, 2011, San Juan, PR). *VHA Handbook 1200.05. Veterans Affairs Human Research Protection Program 101 T raining (September 29-30, 2011, Arlington, VA). *Determinations of Research, Human Subjects Research, Exemptions, and Expedited Review. Veterans Affairs Human Research Protection Program 101 Training (Septem ber 29-30, 2011, Arlington, VA). *IRB Member Responsibilities. University of Texas M.D. Anderson Cancer Center ( November 2010, Houston, TX). *Common Findings from OHRP Determination Letters. University of Texas M.D. Ande rson Cancer Center (November 2010, Houston, TX). *Investigator Responsibilities. University of Texas M.D. Anderson Cancer Center (November 2010, Houston, TX). *Training IRB Members and Staff. The National Association of IRB Managers (May 7, 2010, New Orleans, LA). *The Basics of Human Subjects Protections - OHRP Regulations and Guidance. SRA International: 2009 Midwest Section Meeting (May 5, 2009). *Common Findings from OHRP Determination Letters. SRA International: 2009 Midwes t Section Meeting (May 5, 2009). *OHRP Guidance: Challenging human Subject Protection Issues. Association of Cli nical Research Professionals, Global Conference and Exhibition 2008 (April 29, 2 008, New Orleans, LA). *OHRP Guidance on Reviewing and Reporting Unanticipated Problems. Association o f Clinical Research Professionals, Global Conference and Exhibition 2008 (April 29, 2008, New Orleans, LA). *Office for Human Research Protections - Regulations and Guidance. From Past t o Future: Protecting Research Subjects as Time Change: An OHRP Research Communit y Forum (April 4, 2008). *NIH Mini Session. 2008 NIH Regional Seminar: Program Funding & Grants Administ ration (March 25-26, 2008, San Antonio, TX).

*The Art of Writing Minutes. PRIM&R 2007 HRPP Conference (December 3, 2007, Bos ton, MA). *Regulatory Considerations for IRB. PRIM&R 2007 HRPP Conference (December 3, 20 07, Boston, MA). *Ten Top Investigator Responsibilities. Research Forum: Rapid City Regional Hos pital (October 26, 2007, Rapid City, SD). *IRB Considerations. Human Subjects Protections Workshop for Bluefield State Co llege (September 11, 2007, Bluefield, WV). *IRB Membership and Responsibilities. Human Subjects Protections Workshop for B luefield State College (September 11, 2007, Bluefield, WV). *Human Subjects Protections. Human Subjects Protections Workshop for Bluefield State College (September 11, 2007, Bluefield, WV). *Creating an Institutional Review Board (IRB): The Basics. Research for Native Health: Strengthening Partnerships, Promoting Trust, and Increasing Communicatio n (August 22, 2007). *Human Research Protections of the Federal Wide Assurance, IRB, and Legally Effe ctive Informed Consent. 3rd Annual Clinical Forum on Mental Health: Turning Kno wledge Into Practice. (May 15, 2007, Grand Forks, North Dakota). *OHRP: Where We've Been, Where We're Going. Society of Clinical Research Associ ates Annual Conference: Legal, Ethical and Practical Considerations in Protectin g Human Subjects (April 11, 2008). *Clarifying the Role of IRB Members and Administrative Staff: Regulatory Requir ements & Responsibilities. Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008 (February 8, 2007, Sacramento, CA). *Human Subjects Protections: Regulations and Guidance. Thinking Outside the Box : Addressing the Challenges of Human Subject Research in 2008 (February 8, 2007, Sacramento, CA). HHS Office for Human Research Protections (OHRP) Quality Assessment Workshops. (~every 6 weeks between November 2006 and December 2009) *Overview of Regulations (History and Ethics) *Institutional Administrative Considerations *IRB Membership *IRB Written Policies and Procedures *Writing an SOP *IRB Records and Meeting Minutes *Institutional Policies and Procedures (for those who outsource an IRB) *Mock IRB OHRP Training Videos (Script development and acting, 2009-2010) *Research Use of Human Biological Specimens and Other Private Information *Reviewing and Reporting Unanticipated Problems and Adverse Events *General Informed Consent Requirements *Institutional Review Board (IRB) Membership *Complex Issues with Research Involving Vulnerable Populations *IRB Records BOOK CHAPTER: Nellis, K.L., Highsmith, W. E., Leana-Cox, J., Edelman, D., Stass, S.A. (1998). Molecular Oncology. In R. M. Nakamura, C. L. Burek, L. Cook, J. D. Folds, J.L. Sever (Eds.) Quality Assurance and Standardization in Clinical Diagnostic Immuno logy: Current Concepts Regarding Immunological and Molecular Assays (1st edition , pp. 446-457). Hoboken, USA: Wiley-Blackwell Science. ARTICLES IN JOURNALS: Nellis, K. (1999). Market trends and strategic coping mechanisms. Laboratory Med icine.

deLeon, E., Nellis, K.L. (1991). Procedural overview of molecular genetics tech nology in the clinical laboratory. Clinical Laboratory Science, Sep-Oct;4(5):28 1-3. Haber L.M., Childs C.C., Hirsch-Ginsberg C., Nellis K., Kantarjian H.M., Cork A. , Trujillo J.M., Stass S.A.. (1990). Strategy for breakpoint cluster region anal ysis in chronic myelocytic leukemia in a routine clinical laboratory. American J ournal of Clinical Pathology, Dec;94(6):762-7. Gagnon G.A., Childs C.C., LeMaistre A., Keating M., Cork A., Trujillo J.M., Nell is K., Freireich E., Stass S.A.. (1989). Molecular heterogeneity in acute leuke mia lineage switch. Blood. Nov 1;74(6):2088-95. ABSTRACTS: Dumlar, J.S., Edelman D., Nellis, K., Asanovich, K.M., Trigiani, E.R., Walls, J. , Stass, S. "Molecular Diagnosis of Disease Caused by Noncultivable Pathogenic B acteria: Human Granulocytic Ehrlichiosis." Abstract for Association for Molecula r Pathology. November, 1995. Keller, K. Huh, Y., Huynh, L., Nellis, K., Thandi, D., Hester, J., van Besien, K ., Champlin, R., Andersson, B. "Closed System Percoll-processing of Bone Marrow for Transplantation." Keystone Symposia. January 1994. POSTER: Hirsch-Ginsberg, C., Haber, L., Nellis, K., Kurzrock, R., Keating, M., Huh, Y., Kantarjian, H., and Stass, S. "A Comparison of Immunoglobulin Heavy and Light Ch ain Studies in Peripheral Blood and Bone Marrow for Detecting Disease Status of Hairy Cell Leukemia, Chronic Lymphocytic Leukemia, and Lymphoma." Abstract & Pos ter for the 32nd annual meeting for the American Society for Hematology REFERENCES: Marian Serge, RN U.S. Department of Veterans Affairs Program for Research Integrity Development & Education (PRIDE) (301) 279-8841 (Retired Co-Worker and former FDA employee) dgemjs@comcast.net Elyse Summers, JD Director, Division of Education and Development U.S. Department of Health and Human Services, Office for Human Research Protecti ons (OHRP) (240) 453-8236 (Former Supervisor) Elyse.Summers@HHS.gov David E. Kleiner, MD, PhD National Cancer Institute Director of Clinical Operations, Laboratory of Pathology (LP) (301) 594-2942 (Former Supervisor) kleinerd@mail.nih.gov