View My VisualCV Online: http://www.visualcv.com/gwendolynbyrd 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). * * * * * * * * 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 Page 1 of 4 View My VisualCV Online: http://www.visualcv.com/gwendolynbyrd 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 • • • • • 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 Page 2 of 4 View My VisualCV Online: http://www.visualcv.com/gwendolynbyrd 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 Page 3 of 4 View My VisualCV Online: http://www.visualcv.com/gwendolynbyrd • 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 Click on the image to view my profile on LinkedIn Los Angeles, CA, United States Bachelor of Arts, Psychology Page 4 of 4