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Vaccine Study Center

Vaccine Study Center Team

Nicola P. Klein, MD, PhD, FAAP

Director

Ousseny Zerbo, PhD

Postdoctoral researcher

Laurie Aukes, RN, BA, CCRA

Research manager

Janelle Baires, RN, BSN

Clinical research nurse manager

Charlie C. Chao, MA, CCRP

Clinical trial research coordinator II

Kristin Goddard, MPH

Project manager

John Hansen, MPH

Group leader consulting

Amber H. Hyman, MPH

Project manager

Debbie C. Jacobs

Clinical trial research coordinator II

Ned Lewis, MPH

Data manager

Adonay Martinez, BA

Research assistant

Myrna McCauley

Senior quality analyst

Lisa Powell, BS

Research project manager

Pat Ross, BA

Research Associate III

Amy Wiesner, RN, BSN, CCRC

Clinical research nurse manager

Nicola P. Klein, MD, PhD, FAAP

Nicola P. Klein, MD, PhD, is the director of the Kaiser Permanente Vaccine Study Center, which she joined as co-director in 2006. She is also a senior research scientist at the Kaiser Permanente Northern California Division of Research. Her research interests include vaccine safety and efficacy, genetic influences on vaccine responses, and vaccine responses among at-risk populations (premature infants and children with chronic or genetic diseases). She is the principal investigator of numerous vaccine safety studies, and has published widely on vaccine safety and efficacy in children and infants. She received her medical degree and her doctorate in biochemistry, as part of the Medical Scientist Training Program funded by the National Institutes of Health, at New York University School of Medicine. She completed her residency in pediatrics at the Lucile Salter Packard Children's Hospital (LPCH) at Stanford University School of Medicine, and subsequently completed a Clinical Immunization Safety Assessment (CISA) Network Vaccine Safety Fellowship, sponsored by the Centers for Disease Control and Prevention, at Stanford. She is board certified in pediatrics, and has served as an adjunct clinical instructor in pediatrics at LPCH at Stanford.

Ousseny Zerbo, PhD

Ousseny Zerbo, PhD, is a postdoctoral researcher in the Vaccine Study Center. His research interest is in vaccination patterns and safety in children diagnosed with autism spectrum disorder and vaccine safety during pregnancy. Prior to his current position, he worked in the Autism Research Program investigating risk factors associated with autism and health care utilization patterns in adults with autism. He received his doctoral training in epidemiology from the University of California Davis. His dissertation work was on maternal infections, particularly influenza during pregnancy as a risk factor for autism spectrum disorders. Before his training in epidemiology, he was a high school biology teacher in Burkina Faso, West Africa, where he was born.

Laurie Aukes, RN, BA, CCRA

Laurie Aukes, RN, BA, CCRA, research manager, has been with the Kaiser Permanente Vaccine Study Center since 1990. Her responsibilities include project management for post-licensure, clinical, epidemiological, and federal collaborative studies. She also serves as a nurse coordinator for Clinical Immunization Safety Assessment (CISA) Network projects. Certified as a clinical research associate (CCRA) by the Association of Clinical Research Professionals, she plans and manages all facets of projects, including data gathering and management; medical record review; proposal, budget, and materials development; supervision of research staff; and liaison with other research sites. She has also worked as a contract study monitor and a hospital nurse. Her research interests include vaccine safety and preventive health care. She holds a bachelor of arts in liberal studies and business from California State University, Hayward, and is licensed as a registered nurse in California.

Janelle Baires, RN, BSN

Janelle Baires, RN, BSN, clinical research nurse manager, provides management support for post-licensure, clinical, and federal collaborative studies; prepares all study-specific Standard Operating Procedures; develops all study materials requiring approval by Kaiser Permanente's Northern California Institutional Review Board, and monitors quality assurance for federally funded projects. She joined us in 2012 as a study site clinical research coordinator. Before coming to Kaiser Permanente, she worked as an acute care nurse and charge nurse. She holds a bachelor of science in nursing from University of San Francisco, and is licensed as a registered nurse in California.

Charlie C. Chao, MA, CCRP

Charlie C. Chao, MA, CCRP, has been with us since 2000 as a clinical trial research coordinator II/certified pharmacy technician. In this role, he supports Kaiser Permanente's Principles of Responsibility; ensures compliance with procedures; maintains the security and confidentiality of participants' data; reviews medical records and test results; and abstracts needed data per protocol requirements. He coordinates and prepares protocol specimens for shipping or storage in accordance with regulations and sponsor shipping guidelines; assists in study closure activities; and coordinates study vaccines storage and shipping. Before joining us, he worked in an outpatient pharmacy at Kaiser Permanente, San Rafael.

Kristin Goddard, MPH

Kristin Goddard came to the Vaccine Study Center in 2015 with over three years of project management experience at Kaiser Permanente Colorado's Institute for Health Research. There she oversaw drug safety surveillance projects under the FDA's Mini-Sentinel effort and vaccine communication projects focused on understanding how and when people make decisions to vaccinate. Before joining Kaiser she completed a Vaccine Policy Fellowship with the National Vaccine Program Office at the U.S. Department of Health and Human Services. As a Senior Project Manager at the VSC she leads federally funded projects including CDC's Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA) work. She is involved in all aspects of projects from proposal and budget development to data analysis and manuscript writing. Her interests include vaccine safety, infectious disease surveillance, health communication and decision making, and evidence based policy-making. Kristin earned a Masters of Public Health in Health Education and Health Behavior from the University of Michigan and a Bachelor of Science in Agriculture and Education from The Ohio State University.

John Hansen, MPH

John Hansen, MPH, has been a Kaiser Permanente Vaccine Study Center group leader consulting (adverse event coordinator and project manager) since 1993. He manages programmers and serves as project manager for post-marketing safety studies, his primary research interest. In his role as a project manager, his responsibilities include planning and coordinating with manufacturers to ensure the safety of vaccines that have been licensed and brought to market. In 2001-2003, he served as a member of the Brighton Collaboration Working Groups on Fever and Intussusception. He earned his bachelor's in sociology and his master of public health, with a specialty in epidemiology/biostatistics, at the University of California, Berkeley.

Amber H. Hyman, MPH

Amber H. Hyman, MPH, joined the Kaiser Permanente Vaccine Study Center in 2016 as a Sr. Research Project Manager. Her responsibilities include project management for post-licensure and epidemiological studies. Before joining us, she worked as a research scientist at the International Vaccine Institute, focused on assessing the effectiveness of an oral cholera vaccine given to displaced populations in southern Malawi. She has also worked in academic research on chronic disease modeling and cost-effectiveness analysis of government assistance programs, She earned her bachelor of arts in public health and mass communications at the University of California, Berkeley, and her master of public health (health policy) at Columbia University. 

Debbie C. Jacobs

Debbie C. Jacobs, clinical trial research coordinator II, has been with us since 2004 coordinating clinical trial research tasks. She provides research, operational, and administrative support to the Kaiser Permanente Northern California principal investigators, the clinical trials administrative director, and other research staff members conducting multiple Food and Drug Administration-regulated clinical trials. Before joining our staff, she was a medical transcriptionist and medical office manager for a private practice.

Ned Lewis, MPH

Ned Lewis, BA, MPH, data manager for the Kaiser Permanente Vaccine Study Center since 1990, is responsible for data management, statistical support, and shared management of the programming team. His research interests include efficient data structures and algorithms, exact statistical methods applied to sequential analysis, new methodology for vaccine safety surveillance, and Unix System administration. In 2008, he was honored with the Margarette Kolczk Award for outstanding performance in epidemiology and biostatistics and contributions to the Vaccine Safety Datalink Project. He holds a bachelor of arts in mathematics from the University of California, Santa Cruz, and a master of public health in epidemiology/biostatistics from the University of California, Berkeley.

Adonay Martinez, BA

Adonay Martinez, BA, joined the Vaccine Study Department in the spring of 2017 as a Research Assistant. His role within the VSC focuses on data entry and the verification for accuracy of clinical trials data with the site investigator nurses. He also provides support to other staff members within the VSC office. Before joining the VSC, Adonay was a Research Apprentice at the Haas School of Business at UC Berkeley, where he involved himself in experimental social psychology. In the future, Adonay would like to further his research and academic interests by pursuing an advanced degree in medical anthrology.

Myrna McCauley

Myrna McCauley has been with the Vaccine Study Department since 2004. She began her career with us as a senior quality analyst performing data entry and monitoring for accuracy of pediatric vaccine injections at various facilities. Myrna's responsibilities now include data entry and support to other staff members as needed within the VSC office. Before joining our staff, she was a Human Resource/Worker's Compensation Administrator at a privately owned company. Myrna received her HR management certificate from the University of Phoenix.

Lisa Powell, BS

Lisa Powell, BS, started with the Vaccine Study Center in 1991 as a research assistant. Currently, she is a Research Project Manager. In her current role, she is responsible for taking care of the department's HR needs, such as hiring and training. She also works closely with the administrative director to plan and coordinate the activities of all non-physician personnel nationally. In addition, she is the remote data manager, responsible for the data entry staff. In this role, she ensures that the data entry staff keeps the data entry flowing and completed in a timely manner, and she manages the queries for all the remote data entry studies.

Pat Ross, BA

Pat Ross has been with the Vaccine Study Center since 1997. In her initial position as a Research Assistant she began working with data cleaning vaccine injection logs, and worked extensively with Research Nurses. She has moved on to become a Research Associate III, and has worked extensively with the Medical Record Analyst staff at Division of Research to complete chart review studies. Pat has designed and implemented data collection tools specific to studies' requirements. She has helped evolve the data collection tools to paper-less Quick Review forms. Pat graduated from UC Berkeley with a degree in English Literature in 1992.

Amy Wiesner, RN, BSN

Amy Wiesner has been administrative director of the Kaiser Permanente Vaccine Study Center since 2016. She plans, directs, and coordinates the activities of all non-physician personnel in Northern California and collaborates with principal investigators and pharmaceutical company administrators to maximize compliance with clinical research standards, protect participant safety, and ensure quality control in all areas of research trials. Before becoming our administrative director, she provided management support for our clinical trials.  She joined us in 1999 as a study site clinical research nurse, with responsibility for recruiting participants, administering investigational study vaccine, and following up with study participants. In addition to her experience in clinical research, she worked as a hospital nurse. She holds a bachelor of science in nursing and a bachelor of science in health science from California State University, Fresno, and is licensed as a registered nurse in California.

In Memoriam

Roger Paul Baxter, MD, FACP

Roger Paul Baxter, MD, FACP, was co-director of the Kaiser Permanente Vaccine Study Center from 2006 until his death in late 2016. As principal investigator for many studies of vaccines, biologics, and the epidemiology of infectious diseases, and the author of extensive studies on vaccine safety and effectiveness, he helped to build the reputation of the Vaccine Study Center as a national resource for vaccine research and expertise. Prior to joining the Vaccine Study Center and devoting himself full-time to research, Dr. Baxter practiced internal medicine and infectious diseases at Kaiser Permanente, Oakland for 15 years. Board certified in both internal medicine and infectious diseases, he led the Kaiser Permanente Influenza Vaccination Program, helping to ensure yearly vaccination for more than 1 million members, and directed Kaiser Permanente's influenza surveillance program for more than 13 years. In 2014, he received the Morris F. Collen Research Award for “answering critical questions about vaccine safety and effectiveness to the benefit of people around the globe.”