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BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
Donna Bigley
Investigational Drug Study Clinical Pharmacy
Specialist
bigleyd
Denver Health Medical Center
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional
education,
Denver,
COsuch as nursing, include postdoctoral training and
eRA COMMONS USER NAME (credential, e.g., agency login)
residency training if applicable.)
INSTITUTION AND LOCATION
California Polytechnic State University,
San Luis Obispo, CA
Creighton University School of Pharmacy and
Health Professions, Omaha, NE
Grant Medical Center, Columbus, OH
DEGREE
(if applicable)
MM/YY
BS
1999
Biochemistry and
Biology
PharmD
2005
Pharmacy
PGY1
Residency
2006
Pharmacy Practice
Resident
FIELD OF STUDY
A. Personal Statement
My expertise over nearly two decades in pharmacy and research experience has given me a wide
background in clinical and operations not only in the inpatient hospital areas, but in all areas of
pharmacy from outpatient, research, investigational drug studies as well as the outpatient clinic
settings. I started my career working within the biotechnology pharmaceutical industry applying
my analytical skills from my undergraduate degree training. This early work in already marketed
and new to market drug development and diagnostic testing kits set my interest in the clinical
research process. I then pursued a higher level of education at Creighton University School of
Pharmacy and Allied Professions. Working toward this Doctorate in Pharmacy I involved myself
with research at the institution and took any teaching opportunity as it was available. At
Creighton I had the opportunity to be a paid research assistant and worked on a Medical Safety
Study where they were investigating the early implementation of an electronic prescription
directly inputted from a handheld device to a printer compared to standard written prescriptions.
I pursued a PGY1 residency in clinical practice at Grant Medical center to broaden my clinical
skills as a pharmacist and designed and implemented my residency research project where I
developed a screening process for non-critically ill diabetic patients that is still used at the
institution. After residency I started my pharmacy practice experience where I staffed as a patient
care pharmacists and served as the interim operations manager at Mount Carmel Health Systems
West. Currently I work as the Investigational Drug Study and Research Pharmacist which is a
clinical pharmacist position here at Denver Health. I do staff occasionally in the inpatient
pharmacy in all areas, Trauma/Emergency Medicine, Oncology, Prior Authorization
Coordinator, General Medicine, Behavior Health, Critical Care and Anticoagulation. Prior to
being in this position I was a Staff Pharmacist at Denver Health trained in all areas of the
hospital including the Discharge Pharmacy, ICU, General Medicine Floors, Oncology Infusion
Center, Anticoagulation Services Inpatient and Outpatient. The research pharmacists
responsibilities are to maintain all investigational studies that handle medications in the hospital
and to support research at our institute including protocol development, IRB submission, IND
Development, interpret data, provide pharmacy support, regulatory support, and study design.
This proposed project seeks to build a unique integrated team from a multidisciplinary approach
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and I fully support the proposed project and will provide onsite guidance for the initial set up,
pharmacy support for the duration of the study, including storage of the product and the
regulatory issues surrounding dispensing Scheduled I substances. In addition will provide
additional support throughout the conduction of the clinical trials to help interpret any issues or
problems related to pharmacy, contribute to interpretation of adverse events, and assist with
publications and presentations during the research dissemination phase of the project.
B. Positions and Honors
Positions and Employment
1995-1999
Pharmacy Assistant, California Polytechnic State University Health Center
Pharmacy, San Luis Obispo, CA
1999
Chemist, Pharmaceutical Quality Control Lab, Oread, Palo Alto, CA
1999
Chemist, Pharmaceutical Quality Control Lab, Genentech, South San Francisco,
CA
1999 - 2000
Chemist, DNA Probe Synthesis Lab, GenProbe, Mira Mesa, CA
2001
Research Associate, R&D Lab, Ista Pharmaceuticals, Irvine, CA
2003
Research Assistant, Creighton University, Omaha, NE
2003
Laboratory Teaching Assistant, Creighton University, Omaha, NE
2002
Pharmacy Intern, Walgreens, Omaha, NE
2002 – 2005 Pharmacy Intern, Target Pharmacy, Omaha, NE
2005 – 2006 Pharmacy Practice Resident (PGY1), Grant Medical Center, Columbus, OH
2005-2014
Pharmacist Per Diem, Target Pharmacy, Ohio and Colorado Territories
2006 - 2007
Patient Care Pharmacist/Interim Operations Manager, Mount Camel Health
System West, Columbus, OH
2008 - 2010
Staff Pharmacist, Denver Health Medical Center, Denver, CO
2010Investigational Drug Study Clinical Pharmacy Specialist, Denver Health
Medical Center, Denver, CO
2012COMIRB Panel B Reviewer, Colorado Multiple Institutional Review Board,
Aurora, CO
Other Experience and Professional Memberships
Membership
2004American Society of Health-System Pharmacists (ASHP)
2003American College of Clinical Pharmacy (ACCP)
2009Rho Chi Honors Society
Teaching Experience
2009Early Practice Experience (IPPE) Preceptor for Doctorate of Pharmacy Program
University of Colorado School of Pharmacy
2010Early Practice Experience (IPPE) Preceptor for Doctorate of Pharmacy Program
Regis University School of Pharmacy
2010Early Practice Experience (APPE) Preceptor Drug Information Rotation for
Doctorate of Pharmacy Program University of Colorado School of Pharmacy
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201020122012-
Early Practice Experience (APPE) Preceptor Institutional Rotation for Doctorate
of Pharmacy Program University of Colorado School of Pharmacy
Early Practice Experience (APPE) Preceptor Drug Information Rotation f for
Doctorate of Pharmacy Program Regis University School of Pharmacy
Early Practice Experience (APPE) Preceptor Institutional Rotation for Doctorate
of Pharmacy Program Regis University School of Pharmacy
Professional Experience
2005-present Active License of Pharmacy, State of Ohio
2008-present Active License of Pharmacy, State of colorado
2009Board Certified Pharmacotherapy Specialist
2010Human Subjects Training, CITI Basics Course, HIPPS, GCP
2014
Pilot Tester ACCP Pharmacotherapy PSAP
Honors
2005 Graduate Creighton Pharmacy School with Honors
C. Selected Peer-reviewed Publications
D. Research Support
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