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NED 2020 Agenda

The ITHS Research Coordinator Networking to Enhance Development (NED) Conference is taking place on January 30th. This is a free, annual, day‐long professional development conference for research coordinators held in Seattle. Participants attend both general sessions and choose relevant breakout sessions to expand their knowledge and skills. A catered lunch and collaborative activities offer coordinators a chance to develop contacts, share ideas, and learn from peers.

The theme for NED 2020 is Study Coordinator Leadership: From Theory to Action.

Attendees should plan to start the day at 8:00am at the UW South Lake Union C-Building for breakfast and check-in. Please see the bottom of this page for directions, parking information and a map of the SLU campus.

Conference Agenda

425 KBNED 2020 Agenda final

Detailed session descriptions and speaker information below.

Session Information

Walk the Path: Tips and Tricks

Keynote Session – Walk the Path: Tips and Tricks

Taking it on the road: one research coordinator’s personal path to identifying and taking advantage of international work opportunities. This opening session kicks off the day and will focus on some tips and tricks for researchers to develop career path goals, access networks and foster relationships for professional growth.

Speaker: Aimee Schantz, University of Washington

Aimee Schantz, M.Ed
. is a Research Coordinator with the Department of Pediatrics at the University of Washington.  Aimee has provided research coordination and management of regulatory affairs for a varied portfolio of research endeavors to include neurodegenerative conditions, infectious disease related cancers, and Mendelian genetics.  Aimee directed the UW Alzheimer’s Disease Research Center’s Neuropathology Core and tissue repository; launched the Clinical Core of the newly funded Pacific Northwest Udall Center of Excellence for Parkinson’s Disease Research; and most recently held a position as Research Operations Manager in Kampala, Uganda with the Global Oncology program of Fred Hutch.  Locally, Aimee has worked on the campuses of Harborview, UWMC, and the Puget Sound VA.  Aimee received her undergraduate degree in the liberal arts at the University of Florida, and her Master’s degree in education from Vanderbilt University.

Aimee Schantz
Ensure a Successful Trial: Things to Think About When Establishing Timeline and Feasibility Assessments for your PI & Research Team (Breakout 1A)

Ensure a Successful Trial: Things to Think About When Establishing Timeline and Feasibility Assessments for your PI and Research Team (Breakout 1A)

Study start-up is a challenging multi-faceted process, in which study feasibility and establishment of expectations are critical to success. In this session, people will learn to identify the different components of study start-up resources/essentials and institutional/clinical engagement. Approaches to communicating study start-up implementation needs, timelines and expectations to PIs, study staff and service areas will be shared. Examples of unanticipated errors when determining start-up feasibility, setting timelines and managing expectations will be explored, and the lessons learned/best practices that were established as a result.

Speaker: Lara Schiff, University of Washington/Seattle Cancer Care Alliance

Lara B. Schiff, MPH,
has worked with psychosocial and health research groups across the country in research implementation and program development and evaluation. She started her career working among communities and organizations conducting health promotion research and evaluation. In 2013, she 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 education, Lara began working in clinical research at the University of Washington as a Clinical Research Coordinator, Clinical Research Manager and Clinical Research Implementation Manager. Over the past six years she has become more engaged in clinical research start-up and implementation at a clinical site level. Lara currently works for the University of Washington Thoracic, Head & Neck Oncology Program at Seattle Cancer Care Alliance.

Lara Schiff, MPH
A Single IRB: The Promise and the Reality (Breakout 1B)

A Single IRB: The Promise and the Reality (Breakout 1B)

Single IRB (sIRB) review is now mandated for most federally-funded research involving human subjects. The policy requires the use of one IRB to accomplish IRB review and approval for all domestic sites. The goal of this requirement is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants. Implementing this policy will require IRBs and investigators to significantly rethink and restructure their processes for multi-site research. This session will discuss the different sIRB policies, how they impact investigators at the time they are writing grants and after the grant is funded, changes IRBs are making to implement single IRB review, and the resources investigators and their teams will need to successfully manage a multi-site study under single IRB review.

Speaker: Adrienne Meyer, University of Washington

Adrienne Meyer, MPA, CIP
, is the Assistant Director of Reliances in the Human Subjects Division at the University of Washington (UW). Adrienne is a regulatory specialist and frequent lecturer on issues associated with regulatory compliance and research ethics in a broad spectrum of research disciplines. Adrienne has been at the UW for nearly 20 years and has worked in many capacities with researchers from nearly every department and research discipline: from behavioral research with young children to first-in-human chemotherapy trials. She is the SMART IRB Ambassador for the West and Pacific region and the IRB representative on ITHS’s Trial Innovation Network team.

Basic Knowledge of Study Design and Methods: Observational Research vs. Intervention (Breakout 1C)

Basic Knowledge of Study Design and Methods: Observational Research vs. Intervention (Breakout 1C)

During this breakout session, research coordinators will learn about different types of study designs, including descriptive, experimental, and observational designs. The session will include a discussion about how clinical research coordinators can use this knowledge to impact their study work.

Speaker: Erin Sullivan, Seattle Children’s

Erin Sullivan is a biostatistician with the Children’s Core for Biomedical Statistics (CCBS) at Seattle Children’s Research Institute. As a part of CCBS, Erin provides consultation and support for PIs in areas including study design, data management, statistical analysis and reporting, and manuscript writing. Prior to joining CCBS, she worked as a research coordinator in both adult and pediatric medicine, as a statistician at the CDC, and as a health industries consultant. She has a Master of Public Health in epidemiology.

erin sullivan
Inclusiveness from Theory to Application (Breakout 2A)

Inclusiveness from Theory to Application (Breakout 2A)

The inclusion of individuals and families with Limited English Proficiency (LEP) in research is critical, so that we can hear and learn from these important voices, improve our care of the LEP population, and increase the generalizability of research findings. This session will provide an overview, based on empirical research, of the importance of involving research participants with LEP. In addition, strategies will be shared for approaching patients and families with LEP, working with interpreters, addressing regulatory requirements, and the translation of consent forms and other documents.

Speaker: Kelly Shipman, Seattle Children’s

Kelly Shipman
is a clinical research coordinator at the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute. She currently works on research projects in bioethics and pediatric palliative care, following work in oncology clinical trials and healthy volunteer trials within infectious disease. Kelly has 15 years of experience supporting multiple aspects of research coordination, serving in patient-facing, regulatory, project management, and quality assurance roles. In addition, she serves on the leadership team for the Seattle Children’s Clinical Research Coordinator Discussion Group, which aims to support research coordinators in their daily work and growth. She is currently working on developing her own research to increase the participation of individuals with LEP in research studies.

Placebos, Randomization, and Financial Incentives – oh my! Balancing Ethical Considerations in Clinical Research (Breakout 2B)

Placebos, Randomization, and Financial Incentives – oh my! Balancing Ethical Considerations in Clinical Research (Breakout 2B)

In this session, attendees will learn about a framework for considering what makes clinical research ethical. Using a case-based approach, attendees will learn to apply the framework in the context of real-world research approaches including placebos, randomization, and financial incentives. The session will conclude with a small-group case discussion where attendees will practice balancing the elements of the ethical framework.

Speakers: Stephanie Kraft and Katie Porter, Seattle Children’s Research Institution

Stephanie A. Kraft, JD
, is an Assistant Professor at the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute and the University of Washington School of Medicine Department of Pediatrics. She conducts empirical research on issues related to improving informed consent for research, and she also participates in the ITHS Research Bioethics Consultation service. Her primary research interests are in understanding how people make decisions about research participation and in developing interventions to improve study enrollment, especially among historically underrepresented patient populations.

Kathryn M. Porter, JD, MPH is a Research Scientist for the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute. She is the ITHS Bioethics Program Manager and a research bioethics consultant. Her own research focuses on research ethics, improvement of informed consent and the ethical and legal issues related to genetics.

Stephanie Kraft, JD
Kathryn Porter, JD, MPH
HIPAA and Scenarios for Critical Thinking (Breakout 2C)

HIPAA and Scenarios for Critical Thinking (Breakout 2C)

Within this session, we will address a brief overview of HIPAA and engage interactively in scenarios related to HIPAA compliance in research.

Speaker: Sheila Ganti, Seattle Children’s

Sheila Ganti
has been a coordinator at Seattle Children’s for about four years. Prior to that, in another life, she trained as a bench scientist, so she has been involved with research in one form or another for the better part of 15 years. Sheila works on several tissue banking/GWAS type studies and many studies involving vascular anomalies. One of her passions is working with study teams to identify ways to meet study milestones.

Quality Improvement Culture: How to Continue Evaluation Through the PDCA Approach (Breakout 3A)

Quality Improvement Culture: How to Continue Evaluation through the PDCA (Plan Do Check Act) Approach (Breakout 3A)

With every process there is room for improvement and refinement. In this session, learn about one of those quality improvement processes called the PDCA cycle. Identify tools and approaches that may help with the cycle and work through real-life questions with peers to see how to implement the cycle within your realm of research.

Speaker: Cody Blankenship, Oregon Health Sciences University

Cody Blankenship
is the current Regulatory Project Manager within the Department of Dermatology at Oregon Health and Science University. In her current role she helps to determine feasibility, start-up timelines, negotiate consent and authorization language and manages the regulatory aspect of 30+ studies. Previously, she was the Program Manager for a multi-site longitudinal epidemiology study funded by the VA and DoD, focusing on hearing related implications of recent Service Members. She has a passion for quality assurance and process improvement. When she isn’t working, she enjoys traveling and cooking with her 8 year-old twins and husband.

cody blankenship
Regulatory Year in Review (Breakout 3B)

Regulatory Year in Review (Breakout 3B)

Several significant federal and state regulatory changes implemented this year were designed to reduce the administrative and regulatory burden for research – especially clinical research. This session will discuss those changes, what they mean in the short-term versus the long-term for clinical research, how to identify which research is affected, and where to go for resources.

Speaker: Karen Moe, University of Washington

Karen E. Moe
is the Director of the Human Subjects Division (HSD) at the University of Washington (UW). HSD and the UW Institutional Review Boards (IRBs) that it manages perform the federally-required review of human subjects research that is conducted by UW faculty, staff and students and a few local institutions. HSD staff also provide guidance to researchers about regulatory and ethical issues. Until recently, Karen was also a research associate professor at the UW, where she had a federally-funded research program on sleep in older humans for about 15 years prior to joining the Human Subjects Division. She became the Director of the Human Subjects Division in 2007.

Karen Moe Photo
All These Dang Rules: Why Do We Have to Follow Them? (Breakout 3C)

All These Dang Rules: Why Do We Have to Follow Them? (Breakout 3C)

Compliant research billing is a core component of a financially successful clinical research study. We will discuss the factors that impact research billing decisions, and the steps you can take to ensure you don’t blow your study budget or attract the attention of Department of Justice investigators.

Speaker: Eli Reis, University of Washington

Eli Reis
is a Communications and Training professional with the University of Washington Clinical Trials Office. Eli has more than 20 years of experience supporting the business side of medicine, from one-on-one coaching and classroom training, to acting as site leader for the implementation of an enterprise wide electronic medical record system. Eli is a certified Epic trainer, co-chairs the Clinical Research Coordinator Peer Network, and advises on multiple research-related initiatives at UWM.

Eli believes in the power knowing of “why” as motivation, the value of professional relationships and collaboration, and that you’re never too old to join a punk band.

How to Talk to Your PI about Good Clinical Practices: Non-Compliance, Guidelines or Inappropriate Issues

How to Talk to Your PI about Good Clinical Practices: Non-Compliance, Guidelines or Inappropriate Issues

In the closing session we will teach coordinators how to communicate effectively with the investigator about issues relating to noncompliance, GCP, inappropriate issues, adverse events, and changes in standard practices/policies. We will offer different real life scenarios of how these issues were effectively communicated to investigators.

Speakers: Cody Hammer, University of Washington and Tara Bumgarner, Seattle Children’s

Cody Hammer 
is a Clinical Research Manager with UW Medicine’s Division of Hematology, a Certified Clinical Research Professional, and a Clinical Research Consultant with Glycomimetics Inc.

Tara Bumgarner has been working at Seattle Children’s for over 4 years in their gene therapy and gene editing programs as the lead clinical research coordinator. In the past, she worked with the Seattle Children’s Oncology cooperative groups for 3 years and almost 7 years with Dr. John Hansen and the transplant group at Fred Hutch. Prior to Fred Hutch, Tara worked almost 3 years as a lab research assistant in the Ferric Fang lab at University of Washington.

Cody Hammer
Tara Bumgarner

Getting to UW SLU

UW SLU is located at 850 Republican Street, Seattle, WA.

Parking is available in the garages at UW SLU. The daily rate is $21 and the payment kiosk does not accept cash. Unfortunately, we are unable to validate parking for attendees.

If you have a monthly UW campus parking pass, you will be able to get out-of-area parking at the C-Building reception desk.

Please see the pdf below for more information about parking, shuttles and public transit at the campus.

283 KBGetting to 850 Republican NED

NED will begin and end in Orin Smith Auditorium in UW SLU’s C-Building. Some of the breakouts and the networking lunch will be taking place in the E- and F-buildings across 8th Ave N. Here is a map of the campus to help you find your way.

a map of the UW SLU campus
click to enlarge

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.