Each boot camp session is open to both investigators and research staff. While some sessions may be more specific to either investigators or research staff roles, registrants are welcome to choose the sessions that interest them, regardless of role or experience.
Click to download a PDF version of the 2022 Boot Camp schedule.
Monday, July 18, 12–1pm PDT
Panel members will describe their initial experience as investigators in clinical trials, including how well their prior training prepared them for the new role, whether they encountered any surprises, and how they managed unfamiliar responsibilities.
Stephanie Lee (Moderator)
Professor, Fred Hutch and ITHS Co-PI
Stephanie Lee is a Professor at Fred Hutchinson Cancer Center and University of Washington. She holds the David and Patricia Giuliani/Oliver Press Endowed Chair for Cancer Research. She is an NIH-funded clinical investigator whose research interests include health services/outcomes research, quality of life/patient reported outcomes, and allogeneic hematopoietic cell transplantation with a special interest in chronic graft-versus-host disease (GVHD). She is the Principal Investigator of the Chronic GVHD Consortium, a group of US institutions that collaborate to conduct observational and therapeutic trials of chronic GVHD. She has published over 450 articles in peer-reviewed journals and is a member of American Society of Clinical Investigation and the Association of American Physicians. Dr. Lee also holds a number of leadership positions including Associate Director of the Clinical Research Division and Research Director of the Transplant Long-Term Follow-Up Program at Fred Hutchinson and Co-Scientific Director of the Immunobiology and GVHD Working Committees of the Center for International Blood and Marrow Transplant Research. She was the 2020 President of the American Society of Hematology.
Cate Pihoker
Professor of Pediatrics, University of Washington; Division Chief, Pediatric Endocrinology, PI, SEARCH for Diabetes in Youth Study, co-investigator, RADIANT study, TrialNET, SEARCH Food Security and SEARCH HDL studies
Catherine Pihoker received her MD from Jefferson Medical College in Philadelphia, Pennsylvania, completed her Pediatrics residency at Pennsylvania State University and her Pediatric Endocrinology training at Duke University. She is a Professor of Pediatrics at the University of Washington in Seattle, Washington, USA, and the Division Chief of Pediatric Endocrinology.
Her clinical interests are diabetes and pituitary disorders, including neuroendocrine dysfunction in childhood cancer survivors. She is a Principal Investigator for the SEARCH for Diabetes in Youth study, a multifaceted study of pediatric diabetes in the USA. Areas of particular interest in the SEARCH study, and pediatric diabetes in general, include diabetes classification, sociodemographic and treatment factors affecting diabetes outcomes. In her research and her clinical work she is keen to address inequities in diabetes care.
While serving as a co-investigator on multiple national studies in pediatric diabetes, including TrialNET, RADIANT (a study of atypical diabetes) and Type 1 Diabetes Exchange, she particularly enjoys mentoring trainees and junior faculty in pilot studies, as well as national and international collaborations in pediatric diabetes.
Radica Alicic, MD
Associated Director for Research, Providence Health Care, Providence St Joseph
Clinical Professor of Medicine, University of Washington Department of Medicine
Dr. Radica Alicic is a practicing internist. She serves as an Associated Director for Research at Providence Health Care and a Clinical Professor in the Department of Medicine at the University of Washington. She received her Medical and Master of Science degrees at the University of Sarajevo Medical School in Bosnia and completed her Internal Medicine Residency with the University of Washington Affiliated program. Dr. Alicic serves on the editorial board for the Journal of the Clinical Medicine and is a member of the National Kidney Foundation, Kidney Disease: Improving Global Outcomes (KDIGO) kidney and diabetes-related work groups, and the Executive Council of American College of Physicians, Washington Chapter. Her research interests include pragmatic design and implementation of interventions to improve screening, early recognition, and management of chronic kidney disease, diabetes, and hypertension in real-life settings, including acute care. She is actively engaged in establishing research infrastructure to facilitate integration of research at the point of healthcare delivery.
John A Thompson, MD
Professor, University of Washington and Fred Hutchinson Cancer Center
John A. Thompson, MD, is the Medical Director of the Phase 1 Clinical Trials Program Clinic at the Seattle Cancer Care Alliance. He also serves as a professor in the Medical Oncology Division at the University of Washington School of Medicine and in the Clinical Research Division at Fred Hutchinson Cancer Research Center. Dr. Thompson is board-certified in internal medicine and medical oncology.
Dr. Thompson is a member of several medical societies, including the American Society of Clinical Oncology, the American Association for Cancer Research, the Society for Immunotherapy of Cancer, and the National Kidney Cancer Association. He has authored or co-authored more than 200 articles. Dr. Thompson is Vice-Chair of the NCCN Melanoma Panel and Chair, NCCN Management of Immunotherapy Toxicities Panel.
Tuesday, July 19, 12–1pm PDT
Panel members representing investigators and staff will discuss best practices in meeting regulatory requirements through training, early identification of problems and implementation of corrective action plans.
Nora Disis (Moderator)
Professor
University of Washington
Dr. Disis is the Helen B. Slonaker Endowed Professor for Cancer Research at the University of Washington (UW), Associate Dean for Translational Health Sciences in the UW School of Medicine, Professor of Medicine and Adjunct Professor of Pathology and Obstetrics and Gynecology at UW and a Member of the Fred Hutchinson Cancer Research Center. She is the Director of UW Medicine’s Cancer Vaccine Institute and the Institute for Translational Health Science (ITHS). Her research interest is in the discovery of new immunologic targets in solid tumors for the development of vaccine and cellular therapy for the treatment and prevention of common malignancies.
Guang-Shing Cheng, MD
Associate Professor, Pulmonary and Critical Care Medicine
Fred Hutch and University of Washington
Dr. Guang-Shing Cheng is a pulmonologist focused on improving outcomes for cancer patients who have respiratory failure and lung complications of their cancer treatments. She is developing new ways to prevent lung damage or improve lung function in these patients. Her main interest is bronchiolitis obliterans syndrome (BOS), a serious complication of hematopoietic cell transplantation (HCT). She is also studying the role of respiratory viruses and other infectious pathogens in lung disease in patients with compromised immune systems.
Andrew L. Coveler, MD
Associate Professor, University of Washington, Fred Hutchinson Cancer Center; and Interim Director of Clinical Trials, Cancer Vaccine Institute
Andrew Coveler, MD, is an associate professor in the Division of Medical Oncology at the University of Washington School of Medicine and in the Clinical Research Division at Fred Hutchinson Cancer Research Center in Seattle, Washington, USA. He is the Interim Director of the Cancer Vaccine Institute.
Dr. Coveler received his medical degree from Northwestern University Feinberg School of Medicine in Chicago, Illinois. He completed his internship at Baylor College of Medicine in Houston, Texas, his internal medicine residency at the University of Washington, and a hematology-oncology fellowship at the Fred Hutchinson Cancer Center.
He specializes in the treatment of gastrointestinal cancers. Dr. Coveler’s research encompasses phase I, II and III in GI malignancies, novel agents, and immunotherapy trials. He did one imaging study in medical school and otherwise has worked in clinical trials since 2005.
Dr. Coveler is author or co-author of 3 book chapters, 35 peer reviewed journal articles and 54 abstracts. He has published articles in NEJMm JAMA Oncology, Oncotarget, Current Oncology Reports, Investigational New Drugs and ASCO Education Book, among others.
Sharon McNamara, MN
Research Nurse Manager, Cystic Fibrosis and Pulmonary, Seattle Children’s
Sharon McNamara, MN, has been involved in the conduct of clinical research, primarily in cystic fibrosis, for over two decades. She has worked with investigators at SCH, UW and nationally to design study protocols, develop study materials for regulatory submission, and implement clinical trials, ranging from testing novel outcome measures to Phase I – III trials of new CF therapies. She has collaborated with a wide range of study monitors, while navigating ever-changing regulatory requirements, to ensure data integrity and study success.
Marcie Hall
Clinical Research Coordinator
Fred Hutch Clinical Research Division
I grew up on the East Coast and moved to Washington for my internship after veterinary school. I practiced as an equine veterinarian for one year before deciding I needed a major career change. I still wanted to do something related to medicine, and was lucky to find a PI at Fred Hutch who took a chance on my unusual background and hired me as a research coordinator. I’ve been in this role for 12 years now and I love it. I work with a great team, and I enjoy feeling like I’m making a difference for patients and helping to advance science.
Wednesday, July 20, 12–1pm PDT
Panel members will discuss how they identified and developed a specific area of expertise that offered a career opportunity as a clinical investigator. They will also discuss how they prepared themselves to assume responsibilities as a PI and learned how to manage a study team.
Dr. Bonnie Ramsey (Moderator)
Endowed Professor in Cystic Fibrosis and Vice Chair for Research, Department of Pediatrics, University of Washington School of Medicine
Dr Bonnie Ramsey is an Endowed Professor and Vice Chair for Research in the Department of Pediatrics at the University of Washington School of Medicine in Seattle, Washington. She is a co-PI of the Institute of Translational Health Sciences focusing on child health research. She is a pediatric pulmonologist and clinical scientist with over 30 years of experience in translational research and therapeutic development in the field of cystic fibrosis (CF). She was a lead investigator for development of key therapies in CF including inhaled tobramycin, dornase alpha, and ivacaftor. She has been acknowledged for her contributions to CF including the Paul D’Sant Agnese Award (1998) and the Lifetime Achievement Award (2013) from the Cystic Fibrosis Foundation, the Lifetime Achievement Award from the American Thoracic Society (2014), elected to the National Academy of Medicine in 2015, and received the Warren Alpert Foundation Prize (2018). As the Vice Chair for Research, Dr Ramsey plays a key role in faculty mentorship programs.
Kelley Branch
Professor; and Director, Cardiovascular Clinical Trials
UW Heart Institute
Kelley R. Branch, MD, MSc, FACC, FSCCT, is a Professor in Cardiology at the University of Washington in Seattle, WA and is clinical general cardiologist with a research focus in clinical trials and advanced cardiac imaging. His research support included the NIH KL2 Mentored Training Grant and is currently supported by grants from the NIH and clinical trials. He is Associate Director of the Clinical Trials Service Unit, which facilitates international clinical trials, and is Director of Cardiovascular Clinical Trials Unit. He is also on the Board of Directors for the Society of Cardiovascular CT and on the Editorial Board of European Radiology. Other awards include the American College of Cardiology/Merck Fellowship Award, the Cardiology Teaching Excellence Award, the University of Washington School of Medicine Outstanding CME Teacher, the ACC Emerging Faculty award, and was recently nominated for the University of Washington Distinguished Teaching Award.
Filippo Milano, MD, PhD
Director, Cord Blood Transplant Program
Fred Hutchinson Cancer Center
My background includes a medical degree with honors in 2001 from the University “la Sapienza” of Rome where I graduated first in my class. I have been then a staff physician at the University Hospital in Rome from 2001 to 2008 caring for patients undergoing hematopoietic stem cell transplantation. In 2005 I began a PhD in Hematology at University “La Sapienza”. I moved to Seattle in 2008 to complete my PhD. I finished my PhD in 2010, but I stayed in Seattle where I started a fellowship in Hematology in 2013.
I have published over 80 manuscripts in highly ranked peer-reviewed journals, including a first author paper in the New England Journal of Medicine. I secured NIH and Foundations funding to run investigator-initiated studies. I am member of the American Society of Hematology and of the American Society for Transplantation and Cellular Therapy serving in committees for both societies. Since 2020 I am an Associate Professor at the Fred Hutchinson Cancer Center & University of Washington. I currently serve as Director of the cord blood transplantation program and as Scientific Director of the Cellular Therapy lab at the Fred Hutchinson Cancer Center.
Mignon Lee-Cheun Loh, MD
Chief, Division of Pediatric Hematology, Oncology, Bone Marrow Transplant and Cellular Therapy; Director, Ben Towne Center for Childhood Cancer Research
Seattle Children’s Hospital; Seattle Children’s Research Institute; Fred Hutchinson Cancer Center; University of Washington
Dr. Mignon Loh is center director for the Ben Towne Center for Childhood Cancer Research and chief of the Division of Pediatric Hematology, Oncology, Bone Marrow Transplant and Cellular Therapy, overseeing the Cancer and Blood Disorders Center at Seattle Children’s Hospital. Her research focuses on how and why leukemia progresses, as well as making genomics discoveries in the lab that translate into new and better diagnostics and therapeutics for children, adolescents and young adults with leukemia.
Thursday, July 21, 12–1pm PDT
Panel members will discuss how they have designed clinical trials and obtained the necessary financial support to complete the study successfully. Supply of the investigational product for these studies is a key consideration, often requiring support from a pharmaceutical manufacturer.
Stephanie Lee (Moderator)
Professor, Fred Hutch and ITHS Co-PI
Stephanie Lee is a Professor at Fred Hutchinson Cancer Center and University of Washington. She holds the David and Patricia Giuliani/Oliver Press Endowed Chair for Cancer Research. She is an NIH-funded clinical investigator whose research interests include health services/outcomes research, quality of life/patient reported outcomes, and allogeneic hematopoietic cell transplantation with a special interest in chronic graft-versus-host disease (GVHD). She is the Principal Investigator of the Chronic GVHD Consortium, a group of US institutions that collaborate to conduct observational and therapeutic trials of chronic GVHD. She has published over 450 articles in peer-reviewed journals and is a member of American Society of Clinical Investigation and the Association of American Physicians. Dr. Lee also holds a number of leadership positions including Associate Director of the Clinical Research Division and Research Director of the Transplant Long-Term Follow-Up Program at Fred Hutchinson and Co-Scientific Director of the Immunobiology and GVHD Working Committees of the Center for International Blood and Marrow Transplant Research. She was the 2020 President of the American Society of Hematology.
Ryan Cassaday (he/him)
Associate Professor, Division of Hematology, Department of Medicine, UW; Clinical Research Division, Fred Hutchinson Cancer Center
Ryan did his undergraduate, medical, and Internal Medicine residency training at the University of Wisconsin-Madison. He came to Seattle for Hematology/Oncology fellowship in 2010 and has since stayed on the faculty. His primary role is treatment and clinical research of adults with acute lymphoblastic leukemia.
Sarah Leary
Medical Director of the Pediatric Brain Tumor Program, Seattle Children’s Hospital; Medical Director of Clinical Research, Ben Towne Center for Childhood Cancer Research, Seattle Children’s Research Institution; Professor of Pediatrics, University of Washington School of Medicine; Adjunct Faculty, Fred Hutchinson Cancer Research Center
Sarah Leary completed residency training in Pediatrics at Johns Hopkins in Baltimore, Maryland; and fellowship training in Pediatric Hematology/Oncology at St. Jude Children’s Research Hospital in Memphis, Tennessee. She has been a member of the UW Faculty based at Seattle Children’s Hospital since 2009 where her clinical and research focus is on drug development, precision medicine and clinical trials for children, adolescents and young adults with brain tumors. She completed a masters of epidemiology at the University of Washington and locally serves as the medical director of clinical research at the Ben Towne Center for Childhood Cancer Research at the Seattle Children’s Research Institute. Nationally, she serves on the Brain Malignancies Steering Committee of the NCI and as the Clinical Vice-Chair of the CNS Committee of the Children’s Oncology Group, the largest pediatric clinical trials consortium in the world with over 200 participating institutions. She has led five national therapeutic trials and is currently the Seattle Children’s site PI for over 50 therapeutic trials for childhood cancer.
Peter Leary
Associate Professor of Medicine and Epidemiology, University of Washington; Director of Pulmonary Vascular Disease Program, UW Medical Center
Peter Leary is an Associate Professor of Medicine and Epidemiology in the Schools of Medicine and Public Health respectively. He is also the Director of the Pulmonary Vascular Disease Program for the University of Washington. The overall goal of his research program is to identify and target mechanisms contributing to pulmonary hypertension and right heart failure. He has publications and funding stemming from laboratory-based cardiovascular research, cardiovascular imaging, and cardiovascular epidemiology and is an active investigator in MESA, VA-CART, Servetus, and the National Pulmonary Hypertension Association Registry. That said, what he is most proud of are his wife and two children.
John B. Liao, MD, PhD
Associate Professor, University of Washington School of Medicine and Fred Hutchinson Cancer Center
John B. Liao, MD, PhD is an Associate Professor at the University of Washington. He is the principal investigator of industry and federally funded investigator-initiated phase 1 and phase 2 clinical trials studying immunotherapies for gynecologic cancers. Dr. Liao also leads a translational research laboratory that investigates the immune response to ovarian cancer and develops preclinical models for the disease. He is principal investigator for clinical trials run through the Cancer Vaccine Institute, the Phase 1 Clinical Trials Program, the Immunotherapy Integrated Research Center and the ITHS Translational Research Unit.
Friday, July 22, 12–1pm PDT
Panel members will explain when and why FDA oversight through an IND is necessary. They will highlight FDA guidance documents that explain the expectations that come with an IND and how they apply in an academic setting.
David Hammond (Moderator)
Associate Teaching Professor, University of Washington
David Hammond has worked in the FDA-regulated field for 25 years. He started as a clinical research coordinator first in Boise, Idaho and then in Seattle. After deciding it was time for a change, he moved to the medical device industry. While working as a clinical research associate for a Class 3 medical device trial, he found that he really enjoyed things that plug in to things that you swallow (DISCLAIMER: he does not recommend swallowing the things that are plugged in). He spent the next decade working for a series of medical device companies and through a series of job changes that he thought were well thought out, but were viewed by his parents as the sign of someone who gets bored easily, he found himself unemployed in 2008 after being laid off when his employer underwent downsizing. This led to David deciding that his next adventure would be consulting, so with absolutely no planning, he began consulting with local biotechnology companies until, as he said, he found a real job. Thirteen years and zero real jobs later, he still consults among other activities. He is currently the principal consultant (well, really the only consultant) at Hammond Clinical Trial Consulting, the VP of Clinical, Regulatory, and Quality at MagForce USA (a nanomedicine company focusing on prostate cancer), Associate Teaching Professor in the BRAMS program at the University of Washington where he gets to tell bad jokes to students and they have to laugh if they want to pass, and the Director of Research Integrity and Chair of the IRB at Bastyr University.
Lynn M. Rose, PhD
Affiliate Associate Professor, School of Pharmacy
University of Washington
Lynn Rose is an affiliate associate professor in the UW School of Pharmacy and a founding member of the UW Institute of Translational Health Sciences, Drug and Device Advisory Committee, which advises academic investigators on the regulatory requirements for product development. She was previously a senior executive in the biomedical industry, where she was responsible for preclinical, clinical and regulatory programs. This experience included participation on multiple drug development teams, two of which resulted in marketed products for the treatment of cystic fibrosis and two for hemostasis. Rose shares her expertise in biomedical products, clinical protocols, the development of regulatory strategies and the management of regulatory submissions to federal authorities, to students in the master’s degree and the Biomedical Regulatory Affairs Certificate Program.
Rose’s research experience is in the field of immunology, with an emphasis on autoimmunity, infectious disease and immuno-oncology. She earned her PhD in immunology from the University of Geneva, Switzerland.
Ajay Gopal
Professor, University of Washington and Fred Hutchinson Cancer Center
Dr. Ajay Gopal graduated from Emory University with his M.D before completing an Internal Medicine Residency at Duke University and his Medical Oncology Fellowship at the University of Washington/Fred Hutchinson Cancer Center in Seattle, Washington. From there, Dr. Gopal has specialized in research in Lymphomas and CLL, with a particular interest in radio-immunotherapy and other targeted therapies. Dr. Ajay Gopal is currently the clinical research director and medical director for the hematology and hematologic malignancy program at the Fred Hutch Cancer Center. He has over 180 peer-reviewed publications and has been a mentor of 37 individuals, many of whom have become academic faculty in their own right.
Danielle Zerr
Professor Pediatric Infectious Diseases; Adjunct Epidemiology
University of Washington, Seattle Children’s Hospital, Fred Hutchinson Cancer Research Center
Danielle Zerr attended medical school at Temple University followed by training in pediatrics and infectious diseases and a Masters in Public Health at the University of Washington. Her research has focused on two main areas: (1) Defining the epidemiology of viral pathogens in healthy children and immunocompromised hosts and (2) describing the epidemiology and defining effective prevention strategies for healthcare-associated infections.
Monday, July 25, 12–1pm PDT
The clinical trial start-up process is notoriously complex at any institution. Panel members will discuss how they have founds ways to anticipate problems and improve efficiency, especially in situations where they do not have full control.
John K. Amory, MD (Moderator)
Professor of Medicine, Director UW KL2
University of Washington
John K. Amory MD, MPH, MSc, is a Northwest native who received his undergraduate degree from Harvard University and his MD degree from the University of California, San Francisco, where he also completed his residency in Internal Medicine. Additionally, he has earned both a Master’s degree in Public Health and a Master’s degree in Pharmaceutics from the University of Washington. He is currently a Professor of Medicine and Section Head of General Internal Medicine at the University of Washington Medical Center where he works as an attending physician on the inpatient medicine wards and in the General Internal Medicine and Men’s Health Clinics. Dr. Amory has published more than 175 peer-reviewed papers and chapters in the area of male reproductive health. His work focuses on the development of novel male contraceptives and improved treatments for men with infertility and hypogonadism. He lives in Seattle with his wife, Josie, and sons William and Thomas.
Lara B. Schiff, MPH
Research Implementation Manager
University of Washington
Lara has worked with research programs across the country in research implementation, program development and evaluation. She started her career working among communities and organizations conducting health promotion research and evaluation. Lara received her Master of Public Health degree from University of Michigan’s School of Public Health with a focus in Health Behavior and Health Education and specialization in Research Methods. Upon completion of her graduate school training, Lara began working in clinical research at the University of Washington as a Clinical Research Coordinator, Clinical Research Manager and Clinical Research Implementation Manager. She currently works for the University of Washington Thoracic, Head & Neck Oncology Program and Neuro-Oncology Program at Seattle Cancer Care Alliance.
Ashley McCauley
Assistant Director of Clinical Trial Startup
Fred Hutchinson Cancer Center
Ashley McCauley, MA, CCRP, is the Asst Director of Clinical Trial Startup for Fred Hutch Clinical Research Support (CRS). Ashley oversees the CRS startup team which facilitates centralized comprehensive startup of industry-sponsored oncology trials on behalf of Cancer Consortium investigators. Since 2015, Ashley and her team developed and refined study startup processes that support 100-day startup timelines, standardized minimum requirements, and offered clear expectations, communications and strategies to internal and external stakeholders. These processes have proven consistently effective and are well-received by sponsors and CROs.
Jiwon Yeo
Business Operations Manager, Clinical Research Support Office
Seattle Children’s Research Institute
Jiwon Yeo is the Business Operations Manager for the Clinical Research Support Office (CRSO) at Seattle Children’s Research Institute where she is currently leading coverage analysis and CTMS implementations. She oversees other central clinical trial start-up activities of CRSO, such as study intake, internal budget development, and study activation. Prior to her current role, she oversaw pre-award and post-award activities of the Phase 1 Oncology Clinical Trials Program at UW Medicine.
Tuesday, July 26, 12–1pm PDT
Panel members will discuss how they estimate the numbers of subjects who fulfill both the inclusion and exclusion criteria for a study. An equally important consideration is the proportion of eligible subjects who would be willing to participate in the study based on the anticipated benefits balanced by burdens of participation.
Paul J. Martin, MD (Moderator)
Professor Emeritus, Clinical Research Division, Fred Hutchinson Cancer Center
Professor Emeritus, Department of Medicine, University of Washington
Paul J. Martin, MD, a co-Principal Investigator of the Institute of Translational Health Sciences, served as the Medical Director of Clinical Research Support, the Fred Hutch Clinical Trials Office, from 2011 to 2017. He is a Professor at the Fred Hutchinson Cancer Research Center; and a Professor of Medicine at the University of Washington. Dr. Martin has more than 40 years of experience with hematopoietic cell transplantation at Fred Hutch, focusing on acute and chronic graft-versus-host disease (GVHD).
Amal Saleh, MPH
Program Manager, Research Integration Hub
Seattle Children’s Research Institute
Amal Saleh is a Program Manager in the Research Integration Hub at Seattle Children’s Research Institute. She graduated from the University of Washington with a Bachelor Degree in Sociology and a Master of Public Health in Community Oriented Public Health Practice. She is also working on her Doctor’s Degree in Public Health with a focus in health equity and social justice from Johns Hopkins University. Her work is focused on better understanding the needs of the communities we serve. Amal believes that centering family and youth voices in research can help promote connection and engage those who are research cautious.
Michael Donahue, BS
Research Coordinator
University of Washington’s Clinical Trial Office and Institute of Translational Health Sciences
Michael Donahue, BS, is a Research Coordinator at the University of Washington’s Clinical Trial Office and Institute of Translational Health Sciences. Mike is a seasoned coordinator and provides a wide-range of general research coordination, regulatory support, and study monitoring to investigators. Mike provides research training for investigators and staff, and has become skilled in problem solving recruitment and retention issues. He has provided extensive support for clinical research programs: cardiology, hepatology, nephrology, surgery, oncology, otolaryngology, health services, rheumatology, and rehabilitation medicine.
Michael Louella
Community Engagement Project Manager/Jerome Lab
Outreach Coordinator/UW Positive Research
Community Liaison/UW Fred Hutch CFAR
Michael has worked in HIV treatment research for 20+ years, engaging communities affected by HIV in Seattle and across the U.S. in clinical trials towards the treatment and potential elimination of HIV. He joined the defeatHIV Martin Delaney Collaboratory as their Community Engagement Project Manager in 2013, focusing his efforts around cell and gene therapies for HIV cure. He has formerly worked as a high school English teacher, an actor, a director and producer of summer stock theater, and a baker of bread. He helped to host the Reunion Project Seattle in 2017 and is working to manifest more events for HIV long term survivors in the Seattle area. Recently he joined the Global Gene Therapy Initiative, an alliance of key stakeholders including clinicians, scientists, engineers, advocates & community members brought together to enable access & implementation of gene therapies as curative medicines for presently incurable diseases in low- and middle-income countries.
Wednesday, July 27, 12–1pm PDT
Panel members will discuss how they estimate costs of coordinator effort, data collection and reporting, and financial management. They will offer tips on how to account for costs associated with protocol revisions, monitoring visits and unexpected sponsor or CRO requirements. They will also explain how they negotiate the contract with the sponsor or CRO so as to avoid a deficit.
Paul J. Martin, MD (Moderator)
Professor Emeritus, Clinical Research Division, Fred Hutchinson Cancer Center
Professor Emeritus, Department of Medicine, University of Washington
Paul J. Martin, MD, a co-Principal Investigator of the Institute of Translational Health Sciences, served as the Medical Director of Clinical Research Support, the Fred Hutch Clinical Trials Office, from 2011 to 2017. He is a Professor at the Fred Hutchinson Cancer Research Center; and a Professor of Medicine at the University of Washington. Dr. Martin has more than 40 years of experience with hematopoietic cell transplantation at Fred Hutch, focusing on acute and chronic graft-versus-host disease (GVHD).
Jiwon Yeo
Business Operations Manager, Clinical Research Support Office
Seattle Children’s
Jiwon Yeo is the Business Operations Manager for the Clinical Research Support Office (CRSO) at Seattle Children’s Research Institute where she is currently leading coverage analysis and CTMS implementations. She oversees other central clinical trial start-up activities of CRSO, such as study intake, internal budget development, and study activation. Prior to her current role, she oversaw pre-award and post-award activities of the Phase 1 Oncology Clinical Trials Program at UW Medicine.
Heather Rasmussen
Research Program Manager
University of Washington / Hematologic Malignancies
Heather started her career in clinical research in 2006 as a Research Coordinator in Cardiology for a non-profit. She joined the UW’s Hematologic Malignancies group in December of 2011 as a Research Coordinator. Starting in 2014, Heather began to work in pre-award budget and contract negotiations before growing into the role of Research Program Manager. As the Research Program Manager, Heather is responsible for overseeing the financial, research, and administrative operations of the program.
Tanya Chiatovich
Sr. Director of Business Operations, Research Administration
Fred Hutchinson Cancer Center
Tanya Chiatovich has worked at Fred Hutch for over 16 years, working her way up from Administrative Coordinator to her current role of Sr. Director of Business Operations in Research Administration (RA). In her current role, she leads the RA Programmatic Operations and Strategic Planning office, the RA Project Management Office, and the Immunotherapy Integrated Research Center Finance team which focuses on immunotherapy clinical trial pre-award and post-award activities.
Stephanie Lewis
Sr. Budget Team Lead, MCA certified
University of Washington Clinical Trials Office
Stephanie Lewis joined the Clinical Research Budget and Billing Support Office at the University of Washington in 2005. CRBB later became part of the UW Clinical Trials Office in 2018. During her time at UW, she has held various positions involving clinical research which required budget development and negotiation as well as Medicare Coverage Analysis for clinical trials.
Thursday, July 28, 12–1pm PDT
Panel members will discuss the allocation of responsibilities across team members according to their training. They will explain how they communicate expectations and accountability and how they devise contingency plans for changes in staffing.
Paul J. Martin, MD (Moderator)
Professor Emeritus, Clinical Research Division, Fred Hutchinson Cancer Center
Professor Emeritus, Department of Medicine, University of Washington
Paul J. Martin, MD, a co-Principal Investigator of the Institute of Translational Health Sciences, served as the Medical Director of Clinical Research Support, the Fred Hutch Clinical Trials Office, from 2011 to 2017. He is a Professor at the Fred Hutchinson Cancer Research Center; and a Professor of Medicine at the University of Washington. Dr. Martin has more than 40 years of experience with hematopoietic cell transplantation at Fred Hutch, focusing on acute and chronic graft-versus-host disease (GVHD).
Alana Clark
Research Manager at UW Clinical Trials Office Research Coordination Center
Alana Clark, CCRC is the Research Manager for the Clinical Trials Office Research Coordination Center at the University of Washington. She has worked in academic clinical research for over 16 years and joined the Institute of Translational Health Sciences (ITHS) in 2010. Alana manages a large team of Research Coordinators and Regulatory Specialists at the Research Coordination Center (RCC), which is a dedicated clinical research coordination operation serving dozens of UW departments and divisions as well as partner and external institutions. The RCC provides support for approximately 100 research studies, clinical trials, projects and programs at any given time, across many therapeutic areas. A continued point of focus in this role is participating in the development and execution of research training programs for staff and quality improvement systems to assure high quality clinical research.
In her previous work as a Regulatory Manager, Regulatory Team Lead and Research Coordinator, Alana has worked on a large NIH center grant, acted as a study monitor for FDA Phase I IDE studies and provided extensive support for clinical research programs and multi-site studies. She has worked at the University of Washington, Harborview Medical Center, and SCCA, in the following areas of study: neurosurgery, nephrology, hepatology, cardiology, sports medicine, oncology, vascular surgery, and urology. Her research experience encompasses writing applications for IRB, IND, IDE and other regulatory approvals; providing study implementation support; recruiting and consenting subjects; chart abstraction and completing data collection forms; and creating and carrying out the monitoring plan and activities using the ICH GCP and 21 CFR guidelines. Alana began her research career at the University of Wisconsin-Madison Hospital in Pediatric Asthma and Allergy, and spent four years as a Senior Research Coordinator at the Veteran’s Medical Research Foundation in San Diego specializing in Diabetes Research.
Fatima Ranjbaran
Operations Director – Clinical Research Support/COVID-19 Clinical Research Center
Fred Hutchinson Cancer Center
Fatima Ranjbaran serves as the Operations Director for Clinical Research Support (CRS) and the Covid-19 Clinical Research Center (CCRC) at Fred Hutchinson Cancer Center. The mission of CRS is to ensure the conduct of efficient, compliant, and high-quality clinical research throughout the consortium. Ranjbaran oversees the Central Regulatory, Clinical Trials Coordination, and NCTN Operations teams in CRS, as well as the overall operations of the facility and the onsite clinical and support staff for the CCRC. Ranjbaran has fifteen years of experience in infectious disease and cardiovascular research. With a background in nursing and biochemistry, she brings a mix of care for participants and confidence in the scientific method to her role.
Roxanne Moore
Assistant Director, Clinical Research Operations
University of Washington and Fred Hutchinson Cancer Center
Friday, July 29, 12–1pm PDT
Panel members will discuss how they determine whether a protocol is a good fit for the team and how easily the work could be accommodated within existing clinical practices and capabilities at our center.
Paul J. Martin, MD (Moderator)
Professor Emeritus, Clinical Research Division, Fred Hutchinson Cancer Center
Professor Emeritus, Department of Medicine, University of Washington
Paul J. Martin, MD, a co-Principal Investigator of the Institute of Translational Health Sciences, served as the Medical Director of Clinical Research Support, the Fred Hutch Clinical Trials Office, from 2011 to 2017. He is a Professor at the Fred Hutchinson Cancer Research Center; and a Professor of Medicine at the University of Washington. Dr. Martin has more than 40 years of experience with hematopoietic cell transplantation at Fred Hutch, focusing on acute and chronic graft-versus-host disease (GVHD).
Lori Jarrett
Fred Hutchinson Cancer Center
Elizabeth Stohr
Clinical and Operations Research Services (CORS) Nurse Manager
Fred Hutchinson Cancer Center
Elizabeth has worked in research throughout the consortium collectively for over 15 years in GI, Hematology Oncology, and BMT trials. She has worked in various research roles from assistant, to coordinator, to research nurse and manager. Elizabeth also has extensive clinical and operations experience working early in her career as a Team Coordinator, and eventually as an Interventional Radiology Nurse Coordinator at UWMC while she completed her Masters of Science in Nursing. Elizabeth made her way back to SCCA as the THN and Supportive Care Nurse Manager, then seeing great opportunity to synthesize all her research and clinical operations experience, Elizabeth transitioned into CORS as the Hematology Oncology Clinical Trial Nurse then was promoted to her current role as CORS Nurse Manager.
Kari Stricker, MPH
Director, Clinical Research Operations – Cellular Immunotherapy
Fred Hutchinson Cancer Center
Kari started working at Fred Hutchinson Cancer Center in 2005 with the mini-transplant team. She then continued her career in clinical research as a clinical research coordinator for the thoracic, head and neck team. She also served in roles as a service line manager and in the Quality department prior to her current role as director for clinical research operations in the Immunotherapy Integrated Research Center at Fred Hutch.