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Work experience

Aug 2010Feb 2011

Clinical Coordinator, Division of Cancer Research and Training

CHARLES R. DREW UNIVERSITY OF MEDICINE AND SCIENCE
  • 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 clinical trial procedures
  • Prepared hospital census report
  • Prepared Clinical Trials Information page for Division Web site
  • Attended and coordinated outreach meetings and conferences
Aug 2009Aug 2010

Regulatory/Research Coordinator, Division of NanoMedicine

UCLA SCHOOL OF MEDICINE
  • Prepared Asthma Center for initiation by National Institute of Allergy and Infectious Diseases (NIAID)
  • 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
Apr 2009Aug 2010

Research Coordinator, Weintraub Center for Reconstructive Biotechnology

UCLA SCHOOL OF DENTISTRY
  • 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
Feb 2009Aug 2009

Study Coordinator

LOS ANGELES INFERTILITY & PROSTATITIS MEDICAL GROUP
  • 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
May 2008Nov 2008

Regulatory/IRB Services Administrator, Office of Clinical Trials, David Geffen School of Medicine

UCLA MEDICAL CENTER
  • 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
  • Participated in Quality Assessment Site review of Western Institutional Review Board
  • Performed detailed protocol review
19962008

Research Coordinator, UCLA Medical Center

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

Education

EDUCATION

AWARDS

MEMBERSHIPS

PUBLICATIONS

CONFERENCES

NETWORKING

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

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

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

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 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-player-always 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 & Post-doctoral 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

EXECUTIVE SUMMARY

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).

*Effective communication skills

*Works independently or in collaboration

*Problem solver

*Exceptional interpersonal skills

*Motivated

*Highly organized

*Detail oriented

*Self-disciplined

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)

UCLA Medical Center Computing

Center (MCCS)

Purchasing and Accounting

BruinBuy

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
  • Parkinson Disease Research Workshop, Duke University, Durham, North Carolina, December 1998
  • Psychiatry and the African American Family, UCLA, Spring 1997