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