Videos and Resources

Session Description: Panel members described 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.

Panelists: Stephanie Lee (Moderator), Cate Pihoker, Radica Alicic, and John A. Thompson

Resources:

• ITHS Career Development Series presentation: Establish and Navigate a Research Career: Forging Your Own Path and Expecting the Unexpected

Session Description: Panel members representing investigators and staff discussed best practices in meeting regulatory requirements through training, early identification of problems and implementation of corrective action plans.

Panelists: Nora Disis (Moderator), Guang-Shing Cheng, Andrew L. Coveler, Sharon McNamara, and Marcie Hall

Resources:

• ITHS Career Development Series presentation: The Ins and Outs of Collaboration
• ITHS Career Development Series presentation: Leadership and Team Science: Promoting Team Effectiveness
• ITHS Clinical Research Education Series presentation: Speaking Truth to Power: How to Spot Risk and Guide Your Study PI/Sponsor to Good Patient Outcomes

Session Description: Panel members discussed how they identified and developed a specific area of expertise that offered a career opportunity as a clinical investigator. They also discussed how they prepared themselves to assume responsibilities as a PI and learned how to manage a study team.

Panelists: Bonnie Ramsey (Moderator), Kelley Branch, Filippo Milano, and Mignon Lee-Cheun Loh

Session Materials:

Resources: 

• ITHS Career Development Series presentation: Establish and Navigate a Research Career: Forging Your Own Path and Expecting the Unexpected

Session Description: Panel members discussed 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.

Panelists: Stephanie Lee (Moderator), Ryan Cassaday, Sarah Leary, Peter Leary, and John B. Liao

Resources:

• UW School of Public Health Biostatistics course: BIOST 524 “Design of Medical Studies” on design of medical studies, with emphasis on randomized controlled clinical trials
• Textbook: Friedman LM, Furberg CD and DeMets DL: Fundamentals of Clinical Trials, Fifth Edition (2015), Mosby-Year Book, Inc., St. Louis, Missouri
• American Society of Clinical Oncology week-long training on “Methods in Clinical Cancer Research Workshop” (link is to 2022 session, 2023 session info pending)
• American Society of Clinical Oncology (ASCO) career development programs and activities
• University of Washington MS in Epidemiology (Clinical and Translational Research Track)
• University of Washington Certificate in Clinical Trials – Develop and Conduct Important Drug and Device Testing
• University of Washington Master of Science in Biomedical Regulatory Affairs program
• ITHS Funding Opportunities (Pilot Awards, NIH Diversity Supplements, and Other Funding Opportunities)
• ITHS KL2 and TL1 RFAs
• ITHS Career Development Series presentation: Establish and Navigate a Research Career: Forging Your Own Path and Expecting the Unexpected

Session Description: Panel members explained when and why FDA oversight through an IND is necessary. They highlighted FDA guidance documents that explain the expectations that come with an IND and how they apply in an academic setting.

Panelists: David Hammond (Moderator), Lynn M. Rose, Ajay Gopal, and Danielle Zerr

Resources:

• The ITHS Technology Development Center is staffed with clinical, regulatory, and commercialization experts to assist academic and industry innovators through translation, startup formation, clinical study, regulatory clearance, fundraising, and market entry.
• ITHS Investigational New Drug (IND) Applications for Sponsor-Investigators page with process overview and toolkit.
• University of Washington Certificate in Program Management
• University of Washington Certificate in Biomedical Regulatory Affairs
• University of Washington Master of Science in Biomedical Regulatory Affairs
• FDA Clinical Investigator Training Course (CITC) 2022 (Dec. 7-8, 2022)
• NIH Office of Clinical Research – Introduction to the Principles and Practice of Clinical Research (IPPCR) Course
• Other NIH Courses in Clinical Research
• NIH Research Training and Career Development Programs
• Organization of Regulatory and Clinical Associates (ORCA) Northwest offers trainings, networking, and mentoring resources
• Regulatory Affairs Professionals Society (RAPS) – Main page
• Regulatory Affairs Professionals Society (RAPS) – Vancouver Chapter
• Northwest Association for Biomedical Research

Session Description: The clinical trial start-up process is notoriously complex at any institution. Panel members discussed how they have found ways to anticipate problems and improve efficiency, especially in situations where they do not have full control.

Panelists: John K. Amory (Moderator), Lara B. Schiff, Ashley McCauley, and Jiwon Yeo

Resources:

• ACRP: Association of Clinical Research Professionals
• SOCRA: Society of Clinical Research Associates
• ITHS Career Development Series presentation: How to Build a Research Budget

Session Description: Panel members discussed 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.

Panelists: Paul J. Martin (Moderator), Amal Saleh, Michael Donahue, and Michael Louella

Session Materials:

166 KBHANDOUT: Recruitment Tips155 KBHANDOUT: Recruitment Strategizing Worksheet

Resources:

• ITHS Clinical Research Education Series presentation by Michael Donahue: No Participants, No Trial (Don’t Plan for Everything, but Recruitment)
• ITHS Clinical Research Education Series presentation by Michael Louella: Using Social Media for Your Research Study or Site
• ITHS Career Development Series: Implicit Bias in Health Care and Research
• ITHS Career Development Series: Clinical Translational Research in Partnerships with American Indian and Alaskan Native Communities
• ITHS Career Development Series: Best Practices and Resources for Engagement of Diverse Communities in Clinical and Translational Research
• Unsplash: free downloadable images
• Meta Blueprint: online training for Facebook/Meta marketing
• FDA Clinical Trial Diversity resources
• ITHS Integrating Special Populations
• FHI 360 Stakeholder Engagement Toolkit

Session Description: Panel members discussed how they estimate costs of coordinator effort, data collection and reporting, and financial management. They offered tips on how to account for costs associated with protocol revisions, monitoring visits and unexpected sponsor or CRO requirements. They also explained how they negotiate the contract with the sponsor or CRO so as to avoid a deficit.

Panelists: Paul J. Martin (Moderator), Jiwon Yeo, Heather Rasmussen, Tanya Chiatovich, and Stephanie Lewis

Resources:

• ITHS Career Development Series presentation: How to Build a Research Budget
• Detailed Budget Tool (DBT) referenced by panelists Stephanie Lewis and Heather Rasmussen. Currently only accessible to those with a University of Washington UW NET ID. There is an ask to UW Medicine to see how this tool can be shared out to those who do not have a UW NET ID. The group that maintains this tool is the University of Washington Clinical Research Budget & Billing Support Office (CRBB) and can be contacted via phone at (206) 543-7774
• University of Washington Health Sciences Library’s Clinical & Translational Research Toolkit: Commonly Used Resources for Conducting Research
• University of Washington Health Sciences Library’s TRAIL (Translational Research & Information Lab) Clinical Research Support resources
• Clinical Research Support and Clinical Research Resources Website (CRRW) resources via the Fred Hutchinson/University of Washington Cancer Consortium, a research collaboration comprising Fred Hutch and its strong collaborators: the University of Washington, Seattle Children’s, and the Seattle Cancer Care Alliance
• ITHS: Institute of Translational Health Sciences
• ITHS Resources for Investigators
• ITHS Resources for Education and Training
• ACRP: Association of Clinical Research Professionals
• SOCRA: Society of Clinical Research Associates

Session Description: Panel members discussed the allocation of responsibilities across team members according to their training. They explained how they communicate expectations and accountability and how they devise contingency plans for changes in staffing.

Panelists: Paul J. Martin (Moderator), Alana Clark, Fatima Ranjbaran, and Roxanne Moore

Resources:

• ITHS Career Development Series presentation: The Ins and Outs of Collaboration
• ITHS Career Development Series presentation: Leadership and Team Science: Promoting Team Effectiveness
• ITHS Clinical Research Education Series presentation: Speaking Truth to Power: How to Spot Risk and Guide Your Study PI/Sponsor to Good Patient Outcomes
• University of Washington’s Strategic Leadership Program
• ACRP: Association of Clinical Research Professionals
• SOCRA: Society of Clinical Research Associates
• WCG MAGI: conferences and resources for clinical research coordinators and regulatory coordinators
• Articles on Ontario Protocol Assessment Level (OPAL) tool
• Women in Bio networking group
• Clinical Research Coordinator Handbook, 5th Edition
• High Output Management by Andy Grove
• The Leadership Challenge

Session Description: 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.

Panelists: Paul J. Martin (Moderator), Lori Jarrett, Elizabeth Stohr, and Kari Stricker

Resources:

• SoCRA has an excellent conference which will teach coordinators how to navigate the financial responsibilities of a clinical trial. SoCRA Advanced Site Management: Finance and Productivity Enhanced Business Practices for Clinical Research Programs
• Articles on Ontario Protocol Assessment Level (OPAL) tool
• ITHS Clinical Research Education Series presentation: Speaking Truth to Power: How to Spot Risk and Guide Your Study PI/Sponsor to Good Patient Outcomes