You are on page 1of 5

Laura N. Riser Huntington Beach, CA Phone (714) 655-4286 lr8de566@westpost.net 1.

Therapeutic Experience Orthopedics Osteo-arthritis shoulder Orthopedics: osteo-arthritis knee Osteo-Arthritis Knee Optometry Multi-purpose solution for contact lens care Mycology o Candida, Histoplasmosis, Crypotococosis and Coccidomycoses Virology o Herpes, AIDS, Hanta, Hepatitis C, West Nile Virus, Influenza, SARS, and BK Vi rus Respiratory o Allergy, Asthma, COPD, Eczema o Respiratory Syncytial Virus Central Nervous System o Herpes Encephalitis o West Nile Virus Encephalitis Solid Organ Transplantation o Liver- Hepatitis C o Renal BK Virus 2. PROFESSIONAL EXPERIENCE Pleaid, Inc., Cambridge, MA June 2009 Present Clinical Research Associate III Assist in the management of clinical studies and ensure studies are carried out in accordance with regulatory requirements, GCP and high/ethical quality standa rds Participate in planning of projects, timelines, budgets, resource and inventory Support management of overall project plan and issues that arise Support Project Manager in the management of project staff through mentoring, t eaching and formal development Participate in and provide support in study start-up activities Develop and prepare study documents: protocol, synopsis, CRF, ICF, IB and other regulatory documents Participate in preparation of all project deliverables Serve as resource to site coordinators, investigators and other project staff s uch as monitors Allergan, Inc., Irvine, CA December 2007- January 2009 Clinical Study Manager, Ophthalmology Responsible for regional study management of two Phase III Ophthalmology clinic al trials involving 50 sites in North and South America. Oversight of 1 CRO and 8 vendors Management and oversight of 4 in-house CRAs Manage and monitor study expenses to meet budget forecast Responds to Research Compliance site audit and vendor reports

Alabama Allergy & Asthma Center, Birmingham, AL January 2007 November 2007 Clinical Research Manager Lead the implementation and conduct of phase I-IV clinical trials in the area o f Asthma, Allergy, Eczema and COPD with a primary focus on the treatment resista nt asthma. Negotiate, Develop and Manage project budgets with industry Develop and implement SOPs for the research department Mentor, train and hire research personnel Establish methods ands tools for subject recruitment and retention. University of South Alabama, Mobile AL September 2005- December 2006 Clinical Research Manager for the College of Medicine Voting member of the IRB Review of all clinical trial protocols for new projects, continued review and r enewal of amendments, revision on a monthly basis. Provided GCP and ICH guidelines and HIPPA regulations to university research pe rsonnel Negotiated, Developed and Managed project budgets with industry Conducted QA and assessments and internal checks of productivity. Developed SOPs for research department Managed and assigned protocols for review by other IRB members. Mentored and trained research study coordinators on the monitoring process, ser ious adverse events, and protocol development University of Alabama at Birmingham, Birmingham, AL Department of Medicine/ Division of Infectious Diseases/Pediatric Virology NIAID/NIH Collaborative Antiviral Study Group September 1999-August 2005 Research Nurse Manager Performed site selection and initiation visits throughout 2 European countries Managed over 12 Phase II III clinical trials at 7 sites in Sweden, 1 in the UK, 5 in Canada and 70 in the United States. Prepared regulatory documentation for authorities in UK and Sweden in support o f Phase II-III clinical studies Recruited and trained multi-national clinical research associates Liaised with NIH, FDA and Industry in the protocol development and approval pro cess Prepared for and attended Blinded Data and Safety Monitoring Board meetings. Collaborated with CDC, FDA, NIH and industry to develop and implement clinical protocols for emerging infections. Protocol, Case Report Forms, Source Document, Pharmacy, Lab and Manual of Opera tions Development and Distribution. Responsible for Budget Development & Negotiation with industry and NIH Assisted with the Development of Randomization Schema and blinding issues with biostatistics Planned and conducted Investigator Meetings for Multicenter clinical trials. Assisted the local IRB in the development of a new Serious Adverse Event Form f or campus wide use Collaborated with biostatistics performing edit checks on study data and conduc t of blinded reviews of study data in preparation of interim analysis review and study close out. University of Alabama at Birmingham, Birmingham, AL Burns and Trauma Center September 1997- September 1999 Trauma Nurse Practitioner Supervised clinical operations in out patient Level III Trauma Center

Evaluated, diagnosed and treated out patient trauma patients Provided ongoing care of trauma patients with problems as a result of chronic i njuries Assisted with design and validation of computer applications that stream lined the clinical trial management processes and procedures University of Alabama at Birmingham ,Birmingham, AL Department of Medicine/Division of Infectious Diseases NIAID/NIH Mycoses Study Group August 1991- September 1997 Clinical Trials Coordinator Conducted research protocols in subjects with life-threatening systemic mycoses (candida, cryptococcocosis, histoplasmosis and coccidiomycoses) Maintained highest enrollment in pivotal clinical trial providing the label for use of Fluconazole in candidemia. Recruited and retained subjects in research protocols Attended investigator meetings and study coordinator meeting EDUCATION Undergraduate: University of Alabama at Birmingham, Birmingham, AL 1977-1980 Bachelor of Science, Nursing Deans List Valedictorian Graduate: University of Alabama at Birmingham, Birmingham, AL 1995-1997 Master of Science in Nursing Family Nurse Practitioner 3. PROFESSIONAL DEVELOPMENT GCP Training CITI (Collaborative Institutional Training Initiative) GlaxoSmith Kline, and Wyeth -08/2006 Allergan and Chapman University Leadership Development Certification June 2008-September 2008 4. COMPUTER EXPERIENCE Microsoft Word Microsoft Excel Level II Microsoft Powerpoint Microsoft Outlook Microsoft Visio

5. CLINICAL TRIAL EXPERIENCE A Randomized Trial Comparing Fluconazole with Amphotericin B for the Treatment of Candidemia in Patients with Neutropenia Placebo*Controlled, Double*Blind Trial of Intravenous Ribavirin for the Treatme nt of Hantavirus Cardiopulmonary Syndrome in North America A randomized, open-label study to evaluate the safety and pharmacokinetics of h uman hepatitis C immune globulin (Civacir) in liver transplant recipients Randomized, Controlled Multi-Center Trial of Aerosolized Ribavirin for RSV Uppe r Respiratory Tract in Stem Cell Transplant Recipients Placebo-Controlled, Double-Blind Trial of Intravenous Ribavirin for the Treatme nt of Hantavirus Cardiopulmonary Syndrome in North America A Comparison of Itraconazole Versus Fluconazole as Maintenance Therapy for AIDS

Associated Cryptococcal Meningitis A Phase III Double Blind, Placebo- Controlled Trial of Long Term Therapy of Her pes Encephalitis(HSE): An Evaluation of Valacyclovir A Randomized, Placebo-Controlled,Dose Escalation Study to Assess the Safety and Effect of Cidofovir in Renal Transplant Recipients with BK Virus Nephropathy A Phase I/II Randomized, Placebo-Controlled Trial to Asses the Safety and Effic acy of Intravenous Immunoglobulin G (OMR-IGG-AM) containing High Anti-West Nile Virus Antibody Titers in Patients with or at High Risk for Progression to West N ile Virus (WNV) Encephalitis and/or Myelitis Comparison of Oral Fluconazole and Itraconazole for Progressive, Nonmeningeal C occidioidomycosis Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-as sociated cryptococcal meningitis. The NIAID Mycoses Study Group and the AIDS Cli nical Trials Group Cerebrospinal Fluid (CSF) Hypertension in Patients with AIDS and Cryptococcal M eningitis (CM) PUBLICATIONS Gary L. Davis, David R. Nelson, Norah Terrault, Timothy Pruett, Thomas D. Schia no, Courtney V. Fletcher, Christine V. Sapan, Laura N. Riser, Yufeng Li, Richard J. Whitley, John W. Gnann and the Collaborative Antiviral Study Group. A Random ized, Open Label Study to Evaluate the Safety and Pharmacokinetics of Human Hepa titis C Immune Globulin (Civacir) in Liver Transplant Recipients Liver Transplan tation, Vol 11, No 8 (August), 2005: pp 941-949. Gregory J. Mertz, Lil Miedzinski, Diane Goade, Andrew T. Pavia, Brian Hjelle, C hristine O. Hansbarger, Howard Levy, Fredrick T. Koster, Kenneth Baum, Adeline L indemuller, Wenquan Wang, Laura Riser, Humberto Fernandez, and Richard J. Whitle y for the Collaborative Antiviral Study Group. Placebo-Controlled, Double-Blind Trial of Intravenous Ribavirin for the Treatment of Hantavirus Cardiopulmonary S yndrome in North America. CID, 2004: 39:1307-13. G.J. Mertz, L. Miedzinski, D. Goade, A. Pavia, B. Hjelle, C. O. Hansbarger, H. Levy, F.T. Koster, A. Lindemuller, M. Carpenter, S. Zhang, L. Riser, H. Fernande z, R.J. Whitley for the Collaborative Antiviral Study Group. Placebo-Controlled, Double-Blind Trial of Intravenous Ribavirin for Hantavirus Pulmonary Syndrome i n the US and Canada. In: Program and abstracts of the 43rd International Confer ence on Antimicrobial Agents and Chemotherapy (Chicago, IL) Washington DC: Ameri can Society for Microbiology, 2003 M. Boeckh, J. Englund, M. Carpenter, J. Kuypers, C. Baker, A. Cross, H. Fernand ez, L. Riser, R.J. Whitley for the Collaborative Antiviral Study Group. Randomiz ed, Controlled Multi-Center Trial of Aerosolized Ribavirin for RSV Upper Respira tory Tract in Stem Cell Transplant Recipients. In: RSV 2003 Symposium, Poster P resentation (Stone Mountain, GA) November 8-11, 2003. Graybill JR, Sobel J. Saag M, van Der Horst C, Powderly W, Cloud G, Riser L, Ha mill R, Dismukes W and the NIAID Mycoses Study Group and AIDS Cooperative Treatm ent Groups: Diagnosis and management of increased intracranial pressure in patie nts with AIDS and cryptococcal meningitis. Clin Infect Dis. 2000 Jan;30(1):47-54 Saag, M S., Cloud, G.A., Graybill, J.R., Sobel, J.D., Tuazon, C. U., Johnson, P .C., Fessell, W.J., Moskovitz, B. L., Weisinger, B, Cosmatos, D., Riser, L., Tho mas, C., Hafner, R., Dismukes, W.E., and the Mycoses Study Group. A Comparison o f Itraconazole Versus Fluconazole as Maintenance Therapy for AIDS Associated Cry ptococcal MeningitisCID 1999; 28:291-6 Graybill, J. Richard, Sobel, J.D., Saag, M.S. van der Horst, C.W., Powderly, W. G., Cloud, G.A., Riser, L.N. and the NIAID Mycoses Study Group and the AIDS Clin ical Trial Group. Cerebrospinal Fluid (CSF) Hypertension in Patients with AIDS a nd Cryptococcal Meningitis (CM). [abstract I-153]. In: Program and abstracts of the 37th International Conference on Antimicrobial Agents and Chemotherapy (Toro nto, ON, Canada). Washington DC: American Society for Microbiology,1997. Van der Horst, C.W., Saag, M.S. Cloud, G. A., Hamill, J.R., Graybill, J.R., Sob el, J.D., Johnson, P. C., Tuazon, C.U., Kerkering T., Moskovitz, B.L., Powderly, W. G., Dismukes, W.E., and the NIAID Mycoses Study Group and the AIDS Clinical

Trial Group. Treatment of Cryptococcal Meningitis Associated with the Acquired I mmunodeficiency Syndrome. N Engl Journ 1997; 337:15-21 Wheat, J., Mahwinney, S., Hafner, R., McKinsey, D., Dafent, C., Korzun, A., Sha kan, K.J., et al., NIAID Mycoses Study Group. Treatment of Histoplasmosis with F luconazole in Patients with Acquired Immunodeficiency Syndrome. Amer Journ of Me d 1997; 103:223-32 Pappas, P.G., Rex, J.H., Hamill, R.J., Larsen, R.A., Powderly, W.G., Horowitz, H., Kauffman, C.A., Chapman, S.W., Lee, J., and the NIAID Mycoses Study Group. C urrent Trends in Nosocomial Candidemia: Results of a Large Multi-Center Study . In: Program and abstracts of the 35th Annual Meeting of the Infectious Diseases Society of America (San Francisco, CA) September 13-16, 1997 McKinsey, D.S., Kauffman, C.A., Pappas, P.G., Cloud, G.A., Girard, W.M., Sharke y-Mathis, P.K., Hamill, R.J., Thomas, C.J., Dismukes, W.E., and the NIAID Mycose s Study Group. Fluconazole Therapy for Histoplasmosis. Clin Infect Dis 1996;23:9 96-1001 Cloud, G.A., Saag, M.S., van der Horst, C.W., Hafner, R., Riser, L., Mawhinney, S., Thomas, C., for the NIAID Mycoses Study Group and the AIDS Clinical Trial G roup. Design of a Phase III Trial of Cryptococcal Meningitis in AIDS Patients. S oc for Clin Trial In: 16th Annual Meeting,1995; April 30-May 3 Rex J., Bennett, J.E., Sugar, A.M., Pappas, P.G., van der Horst, C.W., Edwards, J.E., Washburn, R.G., Scheld, W.M., Karchmer, A.W., Dine, A. P., Levenstein, M. J., Webb, C.D., for the Candidemia Study Group and the NIAID Mycoses Study Group . A Randomized Trial Comparing Fluconazole with Amphotericin B for the Treatmen t of Candidemia in Patients with Neutropenia. N Engl J Med 1994;33(1)1325-1330