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Introduction to Clinical Research Boot Camp 2021

Investigator Track Sessions

Agenda

This track is designed for individuals interested in learning about clinical research from an investigator’s perspective.

12:00-1:00pm PDT

Physician vs. the Physician-Investigator: Is there a Difference?

This session will explore the similarities and differences between the role of the physician and the role of the physician investigator, comparing responsibilities in the areas of patient care decisions, treatment interventions, legal accountability, documentation, and collaborators.

Speaker: Paul Martin, MD

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).

Paul martin-sq

12:00-1:00pm PDT

Protocol Design

Poorly designed protocols can result in recruitment problems, inadequate or unreliable data, protocol deviations, and safety issues. This session will guide you through the process of planning and writing a clinical research protocol from the perspective of the Good Clinical Practice (GCP) protocol guidelines to ensure successful implementation of your research study.

Speaker: Paul Martin, MD

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).

Paul martin-sq

12:00-1:00pm PDT

Building An Interdisciplinary Team

In this session, we will discuss the fundamental concepts and features associated with teamwork and will describe strategies for building interdisciplinary research teams.

Speaker: Brenda K. Zierler, PhD, RN, FAAN

Brenda K. Zierler, PhD, RN, FAAN, is a Professor of Biobehavioral Nursing and Health Informatics in the University of Washington School of Nursing. Dr. Zierler’s research explores the relationships between the delivery of health care and outcomes—at both the patient and system level. Her primary appointment is in the School of Nursing at the University of Washington (UW), but she holds three adjunct appointments – two in the School of Medicine (Division of Vascular Surgery and Biomedical Informatics and Medical Education) and one in the School of Public Health (Department of Health Services).

She currently leads a HRSA training grant focused on an education-practice partnership between UW School of Nursing and Kaiser Permanente-Washington designed to recruit and train nursing students and current RNs to practice at the full scope of their license in interprofessional ambulatory care teams. Dr. Zierler is co-lead of the Team Science Core for UW’s Institute for Translational Health Sciences (CTSA). She is the Director of Research and Training for the UW Center for Health Sciences Interprofessional Education, Practice and Research.  Dr. Zierler is a past member of the Institute of Medicine’s Global Forum on Innovation in Health Professions Education. She teaches “Leadership and Team Science” for the Master’s of Science in Clinical Translational Science program in the School of Public Health and in the PhD program in the UW School of Nursing. She also teaches “Quality Improvement, Patient Safety and Informatics” in the UW School of Nursing’s BSN program and teaches “Proposal and Project Development” in the jointly offered Clinical Informatics and Patient Centered Technologies master’s in Science Program (School of Medicine and School of Nursing).

Brenda Zierler

12:00-1:00pm PDT

Responsibilities and Oversight Obligations:
The Critical Role of the Principal Investigator

This is a deep dive into the critical leadership role of the Principal Investigator for a clinical trial. You will work through case studies that highlight important compliance responsibilities, quality assurance, and methods to manage the clinical research team.

Speaker: Ann Melvin, MD, MPH

Ann J. Melvin, MD, MPH, is Professor of Pediatrics, Division of Pediatric Infectious Diseases. Dr. Melvin received her MD and MPH from Tulane University School of Medicine and completed her Pediatric residency and Pediatric Infectious Disease fellowship training at the University of Washington.

Dr. Melvin is the director of the clinical HIV program at Seattle Children’s Hospital where she provides primary care services for HIV-exposed and infected children and adolescents. Her research effort focuses on clinical trials in HIV‐infected children and adolescents to investigate optimal management strategies for initial and long‐term treatment for these children. Through the NIH-funded International Maternal Pediatric Adolescent AIDS Clinical Trials Group, she has been chair or co‐chair of several national and international clinical trials. Dr. Melvin has been the co‐chair of the Regulatory Support and Bioethics Core of the University of Washington Institute for Translational Health Sciences and is now the faculty lead for the ITHS Recruitment Support Service.

Ann J. Melvin, MD, MPH

12:00-1:00pm PDT

Best Practices and Resources for Engagement of Diverse Communities in Clinical and Translational Research

This presentation will provide an introduction to best practices and share ITHS-supported resources for partnering with diverse communities in clinical and translational research. We will discuss benefits and drawbacks to different levels of community engagement so that attendees can learn how to tailor engagement to their research.

Speaker: Laura-Mae Baldwin, MD, MPH

Laura-Mae Baldwin, MD, MPH is a Professor of Family Medicine at the University of Washington (UW) and a seasoned researcher with a focus on implementation of evidence-based interventions into diverse primary care clinical settings. As either Principal Investigator or Co-Investigator on grants funded by federal agencies, foundations, and non-profit organizations, she has developed and applied her quantitative and qualitative research skills in diverse projects involving partnerships with community-based clinicians and clinical organizations. She currently serves as Senior Advisor for the Community Engagement Program within the Institute of Translational Health Sciences (ITHS).

Laura-Mae Baldwin, MD, MPH