2025 Clinical Research Professional Conference

May 7, 2025 8am - 4:30pm | Virtual only

All registered attendees will receive Certificates of Attendance and links to conference recordings/slides by 5/16/25. Email melissa(at)nwabr.org with questions.

Access the Conference Program here. 

Regular Admission: $150

NWABR Member Institutions & SOCRA members: 43% discount with code NWABRMEMBER2025 and valid institutional email address. Please find a list of NWABR member institutions here. 

OHSU faculty, and employees:  75% discount with code OHSU2025 and your ohsu.edu email.

Students: $24 tickets with code STUDENT and valid school .edu email.

Confirmed Sessions & Speakers:

Main Auditorium

• 8:00am Opening Remarks
  • Melissa Tribelhorn, MPA (NWABR)
  • Kitt Swartz, MPH, CCRP (OHSU, Conference Co-Chair)
  • Ray Robles, MBA, CCRP (OHSU, Conference Co-Chair)
• 8:15am Morning Keynote: Quality by Design – Impact from Clinical Trials to Evidence in Practice
  • Meghan Wagner, PharmD, MBA (U.S. DHHS Agency for Healthcare Research and Quality)
  • This keynote will explore how the principles of Quality by Design (QbD) can be applied across the entire clinical trial lifecycle to proactively reduce errors, enhance protocol integrity, and improve participant safety. Attendees will gain insight into how intentional planning, cross-functional collaboration, and continuous learning contribute to operational efficiency and regulatory compliance. Real-world examples will illustrate how integrating QbD principles into trial design and execution leads to higher-quality outcomes, greater data reliability, and reduced burden on both sites and participants. This session addresses quality management, regulatory oversight, and the ethical conduct of clinical research.
  • Objectives:
    Describe the foundational principles of Quality by Design (QbD) and its role in clinical research planning
    Explain the downstream impacts of QbD
    Identify sources for relevant, rigorous, evidence-based information
• 9:30am Right Tool, Right Job: Responsible AI Integration in Clinical Trials
  • Adam Rhine, MSc in Computational Linguistics (Talosix)
  • In clinical research, effective AI integration demands more than adopting the latest technologies - it necessitates carefully selecting the right tools for each workflow and applying them responsibly within a shifting landscape of complex regulatory and technical requirements. This session will introduce a "toolbox" approach to AI in clinical trials, emphasizing the need for a curated, flexible set of AI solutions aligned to specific research tasks. We will explore how to integrate AI tools in ways that not only enhance efficiency and data integration, but also uphold the highest standards of data protection, compliance, and ethical responsibility. Attendees will learn how to build a versatile AI toolbox, navigate the challenges of adoption among diverse research partners, and ensure that every AI application serves the broader mission of safe, effective clinical research.
• 10:45am Evaluating AI Tools
  • Steven Bedrick, PhD (OHSU)
  • As AI tools become increasingly integrated into clinical research, professionals must understand how to critically evaluate their use for compliance, ethics, and scientific rigor. Being able to do this, in turn, requires an understanding of how AI tools function and their strengths and weaknesses. In this session, we will “look behind the curtain” of modern AI models in order to build intuition about their behavior, and to support decision-making around adoption. We will then explore ways that AI is currently being used in clinical trial design, data analysis, and participant recruitment, and will provide a framework for deciding whether and how to use AI assessing tool validity and bias. Attendees will gain practical strategies for evaluating AI technologies, with a focus on identifying the right questions to ask.
• 1:00pm Strengthening Compliance and Quality: Best Practices in Monitoring and Auditing Clinical Research
  • Leah Clemente, MPH, CCRC (Providence Swedish)
  • Samantha Galeski (Swedish Cancer Institute)
  • Effective monitoring and auditing are critical for ensuring the integrity, compliance, and success of clinical research. This session will provide a practical overview of monitoring and auditing strategies, highlight common challenges, and share best practices for protecting participants and maintaining regulatory standards. Attendees will gain actionable tools to strengthen oversight processes and promote a culture of continuous quality improvement across diverse research roles and settings.
• 2:15pm Developing linguistically and culturally tailored virtual study assistants using generative AI.
  • Weichao Yuwen, PhD, RN et al (UW Tacoma)
  • Increased accessibility for underrepresented populations is a widespread goal of translational research. Recent advancements in generative artificial intelligence (AI) could support the process with the use of a virtual study assistant (VSA). In addition, traditional approaches to increasing language accessibility are labor-intensive. Multilingual large language models (LLMs) could support the process, therefore significantly reducing the human resources needed to perform translation and adaptations. This session will describe UW's ITHS Pilot Award-winning study on developing tailored tools for people with different cultural and language backgrounds in CTs and preliminary results.
• 3:30pm Afternoon Keynote: Cultivating a Culture of Compliance and Quality
  • Bridget Adams, MSHS, CCRA (OHSU)
    Paul Newton, JD, CIP (OHSU)
  • Workplace culture is business terminology that describes the priorities and values of a team.  The clinical research community and regulators are now focusing on research workplace culture.  Recent updates to ICH guidelines include expectations for researchers to implement a culture of quality, aligning with long-standing discussions around culture of compliance in clinical research.  This presentation will explore how cultivating a strong clinical research workplace culture can directly enhance study compliance, patient safety, and overall research quality.  We will highlight best practices for establishing and sustaining compliance/quality culture, using a real-world clinical research example, and drawing on Torok, Sam, and Herbert’s (2024) Strategic Enablers framework, which emphasizes critical thinking, employee ownership, leadership commitment, and open dialog.  

Breakout Session

• 9:30am Data Quality in Clinical Research
  • Nicole G. Weiskopf, PhD (OHSU Medical)
  • High-quality data are essential for valid, reliable, and reproducible clinical research. This talk addresses key questions related to data quality in both prospective data collection and the reuse of existing data. We define data quality in operational terms and discuss the differences between random and systematic data quality issues. Strategies for preventing data quality problems during study design and data capture will be outlined, along with methods for identifying and mitigating issues in secondary data sources. The presentation provides an overview to managing data quality across the research lifecycle.

Special Careers in Clinical Research Track

• 10:45am Panel: Mentorship for Students and People New to Clinical Research
  • Tony Keyes, MPA, PMP (Johns Hopkins)
  • Justin Scott Braithwaite, MBA, PMP, CCRP
  • Milan Sheth, MS in Biomedical Science (Houston Methodist Hospital)
  • Stephanie A. Freel, PhD, PMP (Duke)
  • Describe the value and relevance of mentorship to clinical research professionals
    Characteristics of successful mentee/mentor relationships
    Importance of mentee self-advocacy; working with a mentor to help you establish goals for professional development and advancement
    Discuss implementation approaches of formalized and informal mentorship programs in industry and at academic medical centers
• 2:15pm Panel: Building a Meaningful Career in Clinical Research
  • Donielle O'Connor, MEd (Providence Swedish)
  • Leah Clemente, MPH, CCRC (Providence Swedish)
  • This interactive panel will explore diverse career pathways within clinical research, offering practical guidance for students and early-career professionals navigating their next steps. Panelists will share personal experiences, highlight essential skills for advancement, and discuss emerging trends shaping the future of the field. Attendees will leave with actionable insights to support their professional development and long-term success in clinical research.

Special Research Finance Breakout

• 1:00pm Show me the Money! Overview and Career Options in Research Finance
  • Greg Yandl, MBA (Providence Swedish)
  • This conference session delves into the multifaceted realm of research finance, beginning with a personal case study on the speaker's introduction and journey into the field. Attendees will gain insights into the essential body of knowledge required for the Certified Financial Research Administrator exam, emphasizing the critical aspects of grant financial management such as expense allocation. The session will also address the intricacies of clinical trials financials, including invoicing, accounts receivable, and collections, alongside organizational financial planning and analysis (FP&A). Participants will explore career ladders and compensation trends within research finance, while learning to articulate their unique qualifications and transitions into the industry. The session concludes with a long-term industry outlook and a Q&A segment to foster interactive dialogue and personalized advice.

VIRTUAL ATTENDANCE ONLY 

REGISTER HERE

This conference is run in conjunction with Research Week at Oregon Health and Science University (OHSU).  OHSU has a policy of either supporting virtual events or in person events.  OHSU discourages hybrid events due to equity concerns that arise for virtual attendees who cannot receive the same full conference experience as in-person attendees. 

The Planning Committee for this conference has given serious consideration to the OHSU policy and has accordingly decided to hold this conference fully virtually.

CE Credits

• The CIP Council
  • We have requested approval for 6 total hours of CIP credits. Application pending.
• The Association of Clinical Research Professionals (ACRP) 

  • ACRP no longer pre-approves CEs for non-ACRP events. However, conference attendees can self-report activities outside of ACRP events via the guidelines and criteria listed at Maintaining Your ACRP Certification Through Continuing Education and in the ACRP Maintenance of Certification Handbook. For more information on the updated policy, please visit Event Submission for ACRP Contact Hour Approval - ACRP (acrpnet.org).

    Please note that it is not required to upload/submit course certificates at the time of Maintenance, but records should be kept in case attendees are randomly selected to participate in the ACRP Maintenance Verification process. If a Certificant is selected for a random audit, they would then need to provide a certificate of completion and an agenda or flyer that describes the content of the training.

• The Society of Clinical Research Associates (SOCRA)

  • The Society of Clinical Research Associates (SOCRA) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 6.0 hours of CE credit.

    To obtain a SOCRA Certificate of Attendance, please contact patrick@pinkdx.com with your request for recertification credits; please include the presentations attended during the conference.

Sponsors

Potential sponsors are encouraged to contact Melissa Tribelhorn at melissa@nwabr.org for more information. Sponsorship support is key to the successful provision of these events.

This conference is made possible by the member organizations of NWABR who provide the seed capital for the planning of these educational opportunities.  Please visit the member page to find out more about each of these amazing organizations.    

Platinum Members

The University of Washington, or "Udub," is a public research university in Seattle, WA. As the state's flagship university, it serves more than 92,000 students a year and confers greater than 12,000 bachelors, masters, doctoral, and profressional degrees annually. UW has campuses in Seattle, Tacoma, and Bothell, as well as a world-class academic medical center.

WCG is a global leader of solutions that measurably improve and accelerate clinical research. Biopharmaceutical and medical device companies, contract research organizations (CROs), research institutions, and independent sites partner with us for our unmatched expertise, data intelligence, and purpose-built technology to make informed decisions and optimize study outcomes while maintaining the highest standards of human participant protection. WCG raises the bar by pioneering new concepts, reimagining processes, fostering compliance and safety, and empowering those who perform clinical trials to accelerate the delivery of medical therapies and devices that improve lives. To learn more about WCG, visit www.wcgclinical.com.

Need more information?

Reach out to Melissa at melissa@nwabr.org or 206-957-3337.