Gwendolyn Byrd EDUCATION EXECUTIVE SUMMARY

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Gwendolyn Byrd
EDUCATION
REGULATORY/RESEARCH COORDINATOR
EXECUTIVE SUMMARY
Master of Arts, Psychology
PEPPERDINE UNIVERSITY
Graduate School of Education
& Psychology
Bachelor of Arts, Psychology
CALIFORNIA STATE
UNIVERSITY
College of Natural and Social
Sciences
Motivated and dedicated research professional with 16 years of research, administrative and
healthcare experience in a large university setting. Demonstrated success in managing research
projects, clinical trials, and outpatient clinic operations, submitting grant and Internal Review Board
applications, and providing administrative assistance. Manages large projects start to finish, adapting
role as needed to maintain productivity. Experience in managing submissions and training
departmental staff on submissions to a central Internal Review Board (IRB). Strives for flawless results.
Member, Society of Clinical Research Associates (SoCRA).
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Effective communication skills
Works independently or in collaboration
Problem solver
Exceptional interpersonal skills
Motivated
Highly organized
Detail oriented
Self-disciplined
PROFESSIONAL EXPERIENCE
CHARLES R. DREW UNIVERSITY OF MEDICINE AND SCIENCE
MEMBERSHIPS
Los Angeles, CA
Aug 2010 - Feb 2011
Clinical Coordinator, Division of Cancer Research and Training
• Liaised between senior research staff of the Drew/UCLA/Cedars Cancer
research partnership
• Liaised between Clinical Trials Unit Resource, Cancer Outreach Program and
Partner Institutions
• Maintained regulatory documents, binders and IRB submissions
• Prepared for IRB site monitoring visit
• Assisted in protocol preparation, development of oncologists and data training
surveys
• Conducted UCLA-Olive View Clinical Trials Site Visit
• Trained student interns on data abstraction, standard operating procedures and
AWARDS
clinical trial procedures
• Prepared hospital census report
• Prepared Clinical Trials Information page for Division Web site
• Attended and coordinated outreach meetings and conferences
UCLA SCHOOL OF MEDICINE
National Institutes of Health /
National Institute of Diabetes
and Digestive & Kidney
Diseases
Los Angeles, CA, United States
Aug 2009 - Aug 2010
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Regulatory/Research Coordinator, Division of NanoMedicine
Certificate of Appreciation, 2008
• Prepared Asthma Center for initiation by National Institute of Allergy and
Infectious Diseases (NIAID)
PUBLICATIONS
• Served as liaison between sponsor and in-house study team
• Worked with PI to assure compliance with GCP, FDA Regulations and protocol
• Maintained regulatory documents, binders and IRB and Investigational New
Drug (IND) submissions
• Ensured progress of studies from approval, through completion and post-study
activities
• Conducted screening, informed consent process, enrollment, withdrawal and
completion
• Responsible for data management from CRF completion, data entry into
Electronic Data Capture (EDC) systems and query resolution
• Maintained drug accountability
Click on the image for
publication descriptions
UCLA SCHOOL OF DENTISTRY
Los Angeles, CA
Apr 2009 - Aug 2010
Research Coordinator, Weintraub Center for Reconstructive Biotechnology
TECHNICAL
QUALIFICATIONS
DATA COLLECTION
SYSTEMS
ClinPhone Interactive Voice
Response System
Oracle Remote Data Capture
Impala Web-based
Randomization and Drug
Management System
NEUROPSYCHOLOGICAL
TESTING
Mini-Mental Status Exam
HIV Dementia Complex
Life Events Scale
Structured Clinical Interview for
DSM-IV
Trails A & B
Paired Associates and Digit
Span
COMPUTER PROFICIENCY
Microsoft Windows
Microsoft Office
Healthy City California Social
Action Database
Los Angeles County Affinity
Visio
ACT!
Electronic IRB submission
File Transfer Protocol (FTP)
Cyrillic
UCLA Patient Centric
Information
Management System
(PCIMS)
• Responsible for the day to day conduct of clinical trial from start-up to closeout
• Ensured compliance with protocol guidelines and requirements of regulatory
agencies
• Maintained regulatory documents, binders and IRB submissions
• Assisted in the preparation of protocol amendments or modifications to study
design
• Responsible for data entry onto CRFs
• Coordinated focus groups, collected, scored and transcribed data
• Prepared for marketing of Research Core providing facilities, regulatory and IRB
support
LOS ANGELES INFERTILITY & PROSTATITIS MEDICAL GROUP
Santa Monica, CA, United States
Feb 2009 - Aug 2009
Study Coordinator
Responsible for the day to day conduct of clinical trial from start-up to closeout
Served as liaison between clinical trial sponsors and in-house study team
Worked with PI to assure compliance with GCP, FDA Regulations & protocol
Prepared for site qualification, initiation, monitoring and close-out visits
Used Impala and OC RDC Systems for enrollment, subject tracking and data
entry
• Maintained regulatory documents, binders and submissions to Quorum IRB
• Performed electrocardiograms, bladder ultrasound, vital signs and processed
lab samples
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UCLA MEDICAL CENTER
Los Angeles, CA, United States
May 2008 - Nov 2008
Regulatory/IRB Services Administrator, Office of Clinical Trials, David Geffen
School of Medicine
• Facilitated pre-study regulatory submissions process (UCLA IRB and supplemental
committee applications)
• Managed the Western Institutional Review Board (WIRB) pilot program
• Trained department level administrators to participate in the pilot program
• Performed Quality Assessment review of informed consent documents
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UCLA Medical Center
Computing
Center (MCCS)
Purchasing and Accounting
BruinBuy
CONFERENCES
See conference descriptions
in column to the right
TESTIMONIALS
"Gwen was most instrumental
in my success in my last
position as a clinical research
coordinator. She has an
amazing wealth of knowledge in
this field that she was not only
willing to share, but was also
interested that I would be as
successful as possible. Gwen is
definitely a plus to the clinical
research field. She is also a
colleague/supervisor in which
anyone would want to have a
professional association with."
Josephine Eure , Clinical
Research Coordinator , I&P Los
Angeles Infertility & Prostatitis
Medical Group
reported to Gwendolyn at Los
Angeles Infertility and
Prostatitis Medical Group
*****
“Working with Gwendolyn was
a delight and I am sorry that we
are no longer at the same
company. Gwen was a very
dedicated worker who never
complained about being asked
to do work on a tight deadline,
or work that was out of the
scope of her job description.
She got along well with
everyone and brought a sense
of maturity, enthusiasm and joy
to the team. She worked well in
• Participated in Quality Assessment Site review of Western Institutional Review Board
• Performed detailed protocol review
CA, United States
1996 - 2008
Research Coordinator, UCLA Medical Center
• Department of Urology, Aging and Memory Research Center, and Neuropsychiatric
Institute
• Managed clinical trials and observational cohort of urological diseases, memory and
aging, Alzheimer's disease and HIV/AIDS
• Responsible for IRB submission
• Prepared grant progress reports and continuation budgets to funding agencies
• Managed and supervised the submission of center grant to National Institutes of Health
• Responsible for the day to day conduct of clinical trial from start-up to closeout
• Developed Standard Operating Procedures, CRFs and subject tracking system
• Responsible for entering study data onto CRFs, data entry using EDC systems
• Conducted neuropsychological and subject interviews and family history questionnaires
• Managed petty cash fund and multiple research funds
• Assisted in managing payroll and personnel procedures
CERTIFICATIONS
• CITI: Human Research - Biomedical Researchers & Staff, Good Clinical Practice, FDA
Regulated Research, HIPAA, Social and Behavioral Responsible Conduct of Research
• Healthy City Community Research Lab Workshop, 2010
• ENAACT* "Training Program: Enhancing Your Recruitment and Retention Practices Among
Medically Underserved Audiences *(Education Network to Advance Cancer Clinical Trials),
2010
• Investigational Drug Services: Issues Related to Investigational Drugs, 2008
• Ethics in Patient Oriented Research, 2007
• UCLA Certificate in Contract and Grant Administration, 2005
• Good Clinical Practices, 2004
CONFERENCES
24th Annual Pre-Conference Workshop, Working With Your IRB, Septermber 2008
24th Annual Western IRB Training Seminar, September 2008
Quarterly Steering Committee Meetings of the Urological Pelvic Pain Collaborative Research
Network.
Annual UCLA Research Conferences on Aging, 2001 - 2005
EDUCATIONAL ENRICHMENT
• Monthly Research Meetings held by the Division of Cancer Prevention and Control
Research Center in the
• School of Public Health and the Jonsson Comprehensive Cancer Center, 2006 -
2008
• Quarterly Study Coordinator Educational Forum, 2006 - 2008
• Teaching the Responsible Conduct of Research in Humans, Certified, December
2007
• UCLA Geriatric Psychiatry Grand Rounds, 1999 - 2006
• Neuropsychiatric Institute & Hospital (NPI&H) Human Resources Administrative
Training, December 2005
• Understanding NPI Operational Funds, November 2004
• Ethical Considerations in Research Involving Special Populations by Laura
Roberts, M.D., November 2002
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• Parkinson Disease Research Workshop, Duke University, Durham, North
a high-pressure environment
and did it with a sense of
humor. I found her to be a
quick-learner, and was always
open to new ideas. She was
thoughtful in her work and
suggested possible solutions to
problems. I would definitely
describe her as a team-playeralways offering her help to
make sure whatever needed to
be done got done. I would give
Gwen the highest of
recommendations.” August 19,
2011
Mellissa Withers, Ph.D., M.H.S.,
Program Manager & Postdoctoral Fellow in Community
Outreach, Charles Drew
University
managed Gwendolyn at
Charles R. Drew School of
Medicine and Science
*****
“Ms Byrd has vast experience
as a research coordinator and
is an expert in all matters
pertaining to regulatory affairs.
She undertook with us a very
difficult project and thanks to
her dedicationand
professionalism we were able
to comply with the multiple
requirements requested by the
sponsors. She
communicatesvery well and is
able to prioritize well in a
constantly changing
environment. I highly
recommend her.” August 19,
2011
Top qualities: Great Results,
Personable, Expert
Maria Ines Garcia Lloret
hired Gwendolyn as a
Research Coordinator in 2009
Carolina, December 1998
• Psychiatry and the African American Family, UCLA, Spring 1997
PROFESSIONAL RECOMMENDATION
February 19, 2008
To Whom It May Concern:
The purpose of this letter is to provide a recommendation for Gwendolyn Byrd to potential
employers.
Gwen, as a Research Coordinator, worked on a multi-center prostate cancer quality of life
study, under the project management of Angie Titsworth, and Study Principal Investigator,
Martin Sanda, MD.
We have been very impressed with Gwen's efforts throughout the duration of the study.
Gwen's predecessor left her with a very disorganized site. Gwen did tremendous work to
rectify the situation. Gwen has shown amazing dedication to the study by traveling on
occasion in the upwards of 50 miles to meet with subjects so as to avoid loosing contact with
them. When the project manager visited the site, Gwen's organizational skills became very
evident. The organization of the regulatory and subject files is unmatched of any other
visited site. Gwen also put forth great effort in obtaining missing data for study subjects and
was a pleasure to work with.
We are of the opinion that Gwen would make a wonderful addition to any research team.
Sincerely,
Martin Sanda, MD
Beth Isreal Deaconess Medical Center
Boston, MA
Angie Titsworth, Project Manager
University of Michigan
Ann Arbor, MI
Education
Pepperdine University
Los Angeles, CA, United States
Master of Arts, Psychology
NETWORKING
California State University Los Angeles
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Los Angeles, CA, United States
Bachelor of Arts, Psychology
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