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Introduction to Clinical Research Boot Camp 2021

Research Staff Track Sessions

Agenda

This track is designed for individuals interested in learning about clinical research from a research staff perspective.

12:00-1:00pm PDT

Increase Study Success Through Integration of Team Science Competencies

Innovation and study success depends not on the combining of the best people (team of experts) but on creating a psychologically safe environment for team members to collaborate (an expert team). A creative team environment can be intentionally created and anyone can contribute to that creation. Collaborative problem solvers are made—not born. This session will provide insights and resources focused on starting your team off on the right path and highlight the specific behaviors that drive team success. You will walk away with both tools and resources to increase your team’s effectiveness and efficiency.

Speakers: Jennifer Sprecher and Nicole Summerside, MHA

Jennifer Sprecher is the Director of Strategic Planning for the UW School of Nursing and Lean Project manager for cross-disciplinary, multi-site grants.  She provides executive coaching and team facilitation across the UW School of Medicine and the School of Nursing.

With a background in Industrial Engineering, Ms. Sprecher has been working with process improvement for over 25 years using methods including Lean, Lean‐Sigma, Plan Do Check Act and 6S (workplace organization). She works with organizations to implement concepts of project management, measurement systems, change management, benchmarking, and team problem solving to improve organizational performance.

Ms. Sprecher’s measurement and strategic planning uses concepts from Balanced scorecard, Hoshin planning, and cascaded dashboards. Ms. Sprecher is a certified Six Sigma Black Belt.

Jennifer Sprecher

Nicole Summerside, MHA is a Manager of Program Operations for the UW Center for Health Sciences Interprofessional Education, Research and Practice (CHSIE). She delivers program management and support, working to facilitate collaborative environments and team-based care in healthcare settings (research and practice) to improve team functioning, relationships, and patient and system outcomes. Nicole’s background is in Health and Business Administration.

Nicole Summerside

12:00-1:00 pm PDT

Clinical Trial Management Systems: A One Stop Solution

This session will provide an introduction to the OnCore Clinical Trials Management System (CTMS). Users will be introduced to the current functionality of protocol and subject management and the upcoming financials management areas. The session will focus on how the CTMS can enhance collaboration between study teams and the institutions to enhance clinical research operation.

Speaker: Molly Van Rheen, MS, MBA

Molly Van Rheen has over 10 years of research experience including lab, animal, and human subject research as a study coordinator. She worked previously at the University of Colorado managing the OnCore system. Starting in late summer 2019 she joined the Fred Hutch Cancer Research Center, University of Washington, and Seattle Cancer Care Alliance as the CTMS Program Director.

12:00-1:00 pm PDT

An Ethical Framework for Clinical Research:
Rethinking and Going Beyond Informed Consent

In this session, attendees will learn about eight ethical benchmarks for clinical research and practice applying them to real-life case examples, with a focus on the role of researcher-participant interactions.

Speaker: Stephanie A. Kraft, JD

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 conceptual and empirical research on issues related to building trust between researchers and participants and improving informed consent for research. She is also part of the ITHS Research Bioethics Consultation service. Her primary research interests are in understanding how people make decisions about research participation and improving how research teams demonstrate respect to and build trust with potential participants, especially among historically underrepresented patient populations.

Her primary research interests are in understanding how people make decisions about research participation and improving how research teams demonstrate respect to and build trust with potential participants, especially among historically underrepresented patient populations.

Kraft_Stephanie

12:00-1:00pm PDT

ClinicalTrials.gov: Increasing the Transparency of Clinical Trials

This session will introduce attendees to ClinicalTrials.gov and its importance in the clinical research process. We’ll discuss the contents of ClinicalTrials.gov; legal, NIH, and publisher requirements for submitting data; and how this resource benefits researchers and the public. In illustrating the benefits of ClinicalTrials.gov, we’ll focus on its role in increasing the transparency of clinical research and how that contributes to sound scientific practices, public accountability, and opportunities for patients.

Speaker: Leslie Gascon, MBA, MS(LIS)

Leslie Gascon (she/her/hers), MBA, MS(LIS), began as the Health Sciences Library’s Public Health & Collections Librarian on February 1st, 2021. She recently returned to the Pacific Northwest after seven years in the Greater Boston Area, where she earned her Master of Science in Library and Information Science from Simmons University (formerly Simmons College) in August 2019. During her library education, she transitioned to the Boston University Alumni Medical Library from the Boston University Goldman School of Dental Medicine. Throughout her two years at the library, she provided reference services to faculty, students, staff, and health care professionals across the health sciences and curated the print and electronic collections. She continues to pursue equity, diversity, and belonging education and seeks to incorporate these values throughout her life and work. In her role at the University of Washington, Leslie educates and assists Public Health faculty, students, staff, and researchers to identify, manage, and evaluate research. In addition, she evaluates and purchases resources for the Health Sciences Library’s print and electronic collections. Professionally, Leslie is a member of the Medical Library Association (MLA) and Chair-Elect of the MLA Translational Sciences Collaboration Caucus.

Gascon-Portrait

12:00-1:00pm PDT

The Protocol Review: How to Read for both the Big Picture and Your Responsibilities in Implementing a Study

It is essential for research staff to understand fundamental concepts and terminology common to clinical trial protocols. This session will go over sample protocols and describe strategies for reading protocols to maximize study success.

Speaker: Amy Good, PhD

Amy Good, PhD, is a Clinical Research Manager in the Department of Neurology at the University of Washington and focuses on research of Huntington’s Disease. Amy received her PhD in Clinical Psychology with a specialization in rehabilitation and behavioral medicine. She has been involved in health-related research for 20 years.