Skip to content
Clinical Trial Events
Follow

SoCRA Annual Conference · 2026

SoCRA Annual Conference

Sep 25–27

Sep 25–27, 2026 Ended

Sheraton Denver Downtown · Denver, CO · In person

Join over 1,000 of your colleagues at SOCRA's Annual Conference! Each year, SOCRA gathers clinical research professionals from around the world. Immerse yourself in this three-day conference filled with current information, essential tools, best practices, and comprehensive training to ensure your clinical research practice remains up-to-date and compliant. The program boasts expert-led academic sessions, interactive workshops, ample networking opportunities, a peer-driven poster session, and an engaging exhibit program.

Venue
Sheraton Denver Downtown
Program
15 tracks · 176 sessions
169 speakers
Organizer
Society of Clinical Research Associates (SoCRA)
2nd edition of SoCRA Annual Conference

Agenda

Times in Denver (MDT)
Thu, Sep 24 Fri, Sep 25 Sat, Sep 26 Sun, Sep 27

  1. 1:00 PM

    255 min

    Workshop · Monitoring Effectiveness · Governor's Square 16

    Building Effective Monitoring Strategies in Complex Clinical Trials: From SDV Backlog to Audit Readiness

    Angela Robinson-Brown, ThermoFisher Scientific

  2. 1:00 PM

    255 min

    Workshop · Data Management · Plaza Court 3

    Clinical Trial Data Management: From Data to Decision

    Susan Hmwe, City of Hope National Medical Center

  3. 1:00 PM

    255 min

    Workshop · Miscellaneous · Governor's Square 11

    ClinicalTrials.gov Administration: Mastering the PRS Administrator’s Role

    Cristina Ferrazzano Yaussy, Dartmouth Health

  4. 1:00 PM

    255 min

    Workshop · Training · Governor's Square 17

    Culture, Career, Calling: The Blueprint for the Clinical Research Professional

    Jessica Rowe, Yale University Quincy Byrdsong, Ballad Health

  5. 1:00 PM

    255 min

    Workshop · Project Management · Governor's Square 12

    Foundations of Clinical Research Project Management

    Amy Selegue, Caris Life Sciences Haydan Smith, Precision for Medicine Amanda Galster, UT MD Anderson Cancer Center

  6. 1:00 PM

    255 min

    Workshop · Training · Governor's Square 15

    Lead, Teach, Transform: Empowering Clinical Researchers to Educate Principal Investigators

    Katrina Croghan, St. Cloud State University Laura Adkins, UAMS

  7. 1:00 PM

    255 min

    Workshop · Monitoring Effectiveness · Governor's Square 10

    Quality Management

    Abby Statler, AVEO Pharamceuticals, Inc. Alyssa Gateman, Yale Cancer Center

  8. 1:00 PM

    255 min

    Workshop · Site Management · Governor's Square 14

    Unlocking Efficiency: Transform Your Research Site Workflow with Practical AI Strategies

    Casey Jackson, University of Maryland School of Nursing Julie Haltiwanger, FSU

  9. 6:30 PM

    60 min

    Poster · Training

    "A Key Component to an Effective Research Program is Education"

    Kelly Fountain, UAMS

  10. 6:30 PM

    60 min

    Poster · Training

    A Needs-Based International Training Model for Clinical Research Professional Development in Asia: Experience from the Atlas Initiative

    Tomomi Hata, National Cancer Center Hospital

  11. 6:30 PM

    60 min

    Poster · Device Research

    A novel 3-year, double-blind, randomized controlled exercise trial in participants genetically at risk for Parkinson disease

    Michelle Porto, University of Rochester CHeT

  12. 6:30 PM

    60 min

    Poster · International Trials

    Accelerating Global Research Operations through Academic Infrastructure: Lessons from the Dominantly Inherited Alzheimer Network (DIAN)

    Alisha Daniels, Washington University in St. Louis

  13. 6:30 PM

    60 min

    Poster · Regulatory

    Ai Governance in Clinical Research: A Survey-Informed Framework for Responsible Implementation in Regulatory Operations

    Ramya Krishna Chunduru, Independent Researcher

  14. 6:30 PM

    60 min

    Poster · Project Management

    Applying Health Services Research Methods to Develop an Evidence-Informed Protocol Startup Workflow

    Mbuyi Kabongo, National Institute on Deafness and Other Communication Disorders (NIDCD)

  15. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Beyond Informed Consent: Strategies to Improve Engagement, Adherence, and Clinical Trial Participation in Hematologic Oncology

    Ejiroghene Mayor, University of Texas MD Anderson Cancer Center

  16. 6:30 PM

    60 min

    Poster · Site Management

    Beyond Site Initiation: Sustaining Clinic Engagement in Longitudinal Clinical Research

    Jennifer Dolly Prothro, University of Kentucky

  17. 6:30 PM

    60 min

    Poster · Pediatrics

    Beyond the Athlete’s Mask: A Case Study of Diagnostic Delay and Radiographic Progression in Chronic Recurrent Multifocal Osteomyelitis

    Sarika Sanjai, Legend

  18. 6:30 PM

    60 min

    Poster · Site Management

    Biospecimen Quality Oversight in a Multi-Site Pediatric Oncology Consortium: Challenges, Strategies, and Lessons Learned

    Divya Gandra, Penn State Health Golisano Children's Hospital and College of Medicine

  19. 6:30 PM

    60 min

    Poster · Training

    Building Consistency, Equity, and Scalability: Implementing a Unified Approach to Research Education

    Saundra Seabrook, Mayo Clinic

  20. 6:30 PM

    60 min

    Poster · Site Management

    Building a Culture of Trial Readiness: Real-World Implementation of Structured Mock Runs in Oncology and Complex Clinical Trials

    Mohamed Iburahim Haja Maideen, The University of Chicago

  21. 6:30 PM

    60 min

    Poster · Data Management

    Building a Federated Learning Health System for Statewide Public Health Surveillance: The Minnesota Ehr Consortium Experience

    Nayanjot Kaur Rai, University of Minnesota Medical School

  22. 6:30 PM

    60 min

    Poster · Investigator Initiated Research

    Building a Rare Disease Research Program from Bench to Bedside: The GEMINI Protocol Pipeline

    Kelsey Lewis, St. Jude Children's Research Hospital

  23. 6:30 PM

    60 min

    Poster · Training

    Building the Future Clinical Research Workforce: A Medical Assistant to Clinical Research Coordinator Pipeline

    Leticia Alvarado, Lurie Childrens

  24. 6:30 PM

    60 min

    Poster · Decentralized Clinical Trials

    Challenges in Coordinating Remote Clinical Trials in Parkinson’s Disease

    Katrina Schmier, University of Rochester Center for Health and Technology

  25. 6:30 PM

    60 min

    Poster · Site Management

    Characterization of Paper-Based Documentation Management Processes in an Investigational Drug Service

    Mathis Laverdiere, chu sainte-justine

  26. 6:30 PM

    60 min

    Poster · Site Management

    Characterization of Treatment Assignment Confirmations provided by Interactive Web Response Systems in Clinical Studies

    Mathis Laverdiere, chu sainte-justine

  27. 6:30 PM

    60 min

    Poster · Miscellaneous

    Clinical Research Compensation and Participant Burden: Creating a Framework for Transparent and Fair Stipends

    Robin Kuprewicz, Georgetown University

  28. 6:30 PM

    60 min

    Poster · Project Management

    Collaborating with AI: Navigating Clinical Trials in the Digital Age

    Trafina Jadhav, Tsumura USA Inc

  29. 6:30 PM

    60 min

    Poster · Miscellaneous

    Creating Community: Lessons Learned from Launching a Socra Regional Chapter

    Jennifer Farren, National Institutes of Health/NHLBI

  30. 6:30 PM

    60 min

    Poster · Data Management

    Data Querying Process

    Patricia Bustamante, Northwestern University

  31. 6:30 PM

    60 min

    Poster · Data Management

    Designing a Scalable Centralized Redcap Workflow for Multicenter Clinical Research

    Michelle Robert, Dell Seton Medical Center at The University of Texas at Austin

  32. 6:30 PM

    60 min

    Poster · Investigator Initiated Research

    Designing the Sepsis Huddle Trial: A Pre-Implementation Feasibility Assessment for Real-World Clinical Research

    Sachita Shrestha, University of Michigan

  33. 6:30 PM

    60 min

    Poster · Miscellaneous

    Developing an Integrated Emergency Department Clinical Research Program in a High-Volume Academic Medical Center

    Tammy Phan, Loma Linda University Medical Center

  34. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Diversifying Clinical Trial Participation: Leveraging Digital Health Innovations and Community Outreach for Recruitment and Retention Improvements

    Blake Lambert, Arthrex Inc.

  35. 6:30 PM

    60 min

    Poster · International Trials

    Dominantly Inherited Alzheimer Netowrk (DIAN): Accelerating Translation in an Ultra-Rare Neurodegenerative Disorder

    Alisha Daniels, Washington University in St. Louis

  36. 6:30 PM

    60 min

    Poster · Investigator Initiated Research

    Elevated Eco-Anxiety and Steep Discounting of the Future in Select Sub-Groups: Findings from an Ontario General Community Sample of Adults

    Jane De Jesus, McMaster University

  37. 6:30 PM

    60 min

    Poster · Pediatrics

    Elevating Clinical Trial Sites through Comprehensive Site Enablement: A Practical Framework for Operational Excellence.

    Karen Auten, Marom Clinical Consulting

  38. 6:30 PM

    60 min

    Poster · Training

    Elevating the Patient Voice: Advancing Competencies for Meaningful Patient Partner Engagement in Clinical Research

    Carolynn Jones, The University of Alabama At Birmingham

  39. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Engaging Older Adults in Aging and Cognition-Based Outcomes Research: A Comparative Analysis of Successful Recruitment Methods

    Stacee Naylor, The University of MS Medical Center

  40. 6:30 PM

    60 min

    Poster · Data Management

    Enhancing Data Completeness in Histiocytosis and Rare Disease Research

    Adrienne English, St. Jude Children's Research Hospital

  41. 6:30 PM

    60 min

    Poster · Miscellaneous · Plaza Exhibit

    Enhancing Patient Flow Management in a Pediatric Cell Therapy Research Program through an EHR-Based Module

    Aakruti Sharma, Children's Hospital of Philadelphia

  42. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Ethical and Practical Considerations in Enrolling Children with Behavioral Health Disorders in Research

    Muhammad Waseem, Lincoln Medical Center

  43. 6:30 PM

    60 min

    Poster · Device Research

    Feasibility and Tolerability of Deep Rtms for Mild Neurocognitive Disorder in Older Adults

    Jane De Jesus, McMaster University

  44. 6:30 PM

    60 min

    Poster · IRB

    First‑in‑Human Evaluation of a Bacteria‑Targeted PET Radiotracer, [¹⁸F]‑Fluoromannitol

    Jessica Eakes, St. Jude Children's Research Hospital

  45. 6:30 PM

    60 min

    Poster · Training

    From Black Box to Competency: A Book Club Approach to Clinical Trial Literacy in Academic Graduate Research Programs

    Kaitlyn Malley, The University of Texas at Dallas

  46. 6:30 PM

    60 min

    Poster · Investigator Initiated Research

    From Crop to Clinic: Delivering Innovative Food-Based Clinical Research through an Integrated Translational Platform—Lessons Learned from the UK's First Human Dietary Trial Using Gene-Edited Tomatoes

    Jennifer Ahn-Jarvis, Quadram Institutue

  47. 6:30 PM

    60 min

    Poster · Site Management

    From Guesswork to Governance: Implementing a Real-Time Workload Acuity Platform to Transform Clinical Research Staffing and Forecasting

    Evan Hubbard, Highlands Oncology Group

  48. 6:30 PM

    60 min

    Poster · Training

    From Policy to Practice: An Enterprise Approach to GCP E6(R3) Implementation

    Amanda Weston, University Health Network

  49. 6:30 PM

    60 min

    Poster · Decentralized Clinical Trials

    From Protocol Table to Operational Roadmap: A Color-Coded Schedule of Assessments Logistics Map for Decentralized and Hybrid Trials

    Lydia Mercado, Mayo Clinic

  50. 6:30 PM

    60 min

    Poster · Site Management

    From Protocol to Practice: Leveraging Visit Checklists and Source Packets to Support Clinical Trial Conduct

    Laura Baird, Rho, Inc.

  51. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    From Prototype to Practice: Lessons Learned from Real-World Deployments of an Artificial Intelligence-Assisted Clinical Trial Matching System

    Anna Folkers, Vizlitics, Inc

  52. 6:30 PM

    60 min

    Poster · Regulatory

    From Reactive to Proactive: Applying the Plan-Do-Study-Act Framework to Build an Audit-Ready Research Compliance Program at the Institute of Behavioral Research (IBR)

    Crystal Moran, Texas Christian University

  53. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    From Research Operations to Research Impacts: Improving Participant Engagement in Multisite Cancer Prevention Research A Collaborative Analysis Examining How the California-Mexico-Puerto Rico (CAMPO) Partnership Center Adapted Recruitment and…

    Jennifer Marino, University of California

  54. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Gamifying Research Recruitment: A Low-Cost Strategy to Engage Orthopaedic Surgery Residents in Clinical Research

    Bryce Rizvanovic, University of Missouri

  55. 6:30 PM

    60 min

    Poster · Investigator Initiated Research

    Hemoglobin A1c Variability, Wound Microbiology, and Amputation Risk after Diabetes‑Related Foot Infection

    Kaitlyn Depinet, Indiana University

  56. 6:30 PM

    60 min

    Poster · Site Management

    Impact of Structured Mock Runs on Trial Execution: A Comparative Study of Two Cellular Therapy Protocols

    Mohamed Iburahim Haja Maideen, The University of Chicago

  57. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Implementation of Research in a Virtual Clinical Trial: Recruitment and Retention Strategies for Pregnant People in the Salt Lake Valley

    Quinn Woolley, The University of Utah Obstetrics and Gynecology department

  58. 6:30 PM

    60 min

    Poster · Training

    Implementing a Standardized Clinical Research Onboarding Program across a Multi-Site Enterprise

    Trevor Stromme, Mayo Clinic

  59. 6:30 PM

    60 min

    Poster · Miscellaneous

    Improving Research Visibility by Maximizing Csp Nodes Team Strengths

    Diana DeFelice, Veterans Affairs Medical Center

  60. 6:30 PM

    60 min

    Poster · Regulatory

    Informed Consent and Reportable Events: An Escape Room to Promote Regulatory Compliance

    Kelly Norris, National Institutes of Health

  61. 6:30 PM

    60 min

    Poster · Miscellaneous

    Insights and Lessons Learned from Implementing the Innovations in Genicular Outcomes Registry (IGOR), a Multicenter Prospective Registry of Knee Osteoarthritis

    Kate Fasel, Pacira Bio

  62. 6:30 PM

    60 min

    Poster · Training

    Integrating Nurse Scientists into Nursing Professional Development: A Collaborative Model for Building Research and Clinical Inquiry Capacity

    Wendy Kreider, Rush University Medical Center

  63. 6:30 PM

    60 min

    Poster · Training

    Keeping CAR T Patients Safe: A Simple One-Page Emergency Guide for New Research Staff

    Meredith del Rosario, University of Texas MD Anderson Cancer Center

  64. 6:30 PM

    60 min

    Poster · Site Management

    Making Trial Start-Up Visible: A Practical Strategy to Accelerate Oncology Clinical Research

    Mohamed Iburahim Haja Maideen, The University of Chicago

  65. 6:30 PM

    60 min

    Poster · Data Management

    Modernizing Nci Ctrp Accrual Reporting: From Manual Reporting to Programmatic Submission Workflow

    Susan Hmwe, City of Hope National Medical Center

  66. 6:30 PM

    60 min

    Poster · Site Management

    Navigating Multi-Site Research at an Academic Institution: Lessons from the next Consortium

    Megan Blue, Nationwide Children's Hospital

  67. 6:30 PM

    60 min

    Poster · Site Management

    Navigating Structural Instability: Effective Approaches for Sustaining Multi-Site Participant Recruitment

    Ryan Leparski, Hines VA Cooperative Studies Program Coordinating Center

  68. 6:30 PM

    60 min

    Poster · Inclusion Diversity Equity Access (IDEA) in Clinical Research Behavior

    Older Adult Experiences Pursing Encore Careers in Research at an Age-Friendly University: Longitudinal Evaluation

    Kathryn Nearing, University of Colorado Anschutz Medical Campus

  69. 6:30 PM

    60 min

    Poster · Miscellaneous

    Operationalizing Expanded Medicare Mnt under H.R. 6199: Workflow, Documentation, and Outcomes for Chronic Wound Care

    Kaitlyn Depinet, Indiana University

  70. 6:30 PM

    60 min

    Poster · Site Management

    Operationalizing Recruitment Management in a Limited Site Environment: A Practical Framework for Setting Site Expectations, Navigating Escalations, and Building Leadership Partnerships.

    Cheryl Odle, U.S. Department of Veterans Affairs

  71. 6:30 PM

    60 min

    Poster · Site Management

    Optimal Study Start-Up

    Janelle Allen, Miami University

  72. 6:30 PM

    60 min

    Poster · Miscellaneous

    Perceptions and Impact of Professional Credentials on Hiring, Advancement, and Development of Clinical Research Professionals

    Samantha Martinek Bundt, The Ohio State University

  73. 6:30 PM

    60 min

    Poster · Monitoring Effectiveness

    Practical Fraud Detection and Prevention in Incentivized Online Surveys: Lessons from the ADOPT Study

    Aaron Begley, University of Kentucky

  74. 6:30 PM

    60 min

    Poster · Investigator Initiated Research

    Prevalance of Lipoprotein (a) in a Diverse High Risk Population

    Olufunke Davies, Med Clinical Research Partners, LLC

  75. 6:30 PM

    60 min

    Poster · Project Management

    Proactively Identifying, Categorizing, and Addressing Protocol Deviations: Real-Time Tracking at a Pediatric Clinical Research Site

    Stephanie Gam, Stanford University

  76. 6:30 PM

    60 min

    Poster · Pediatrics

    Psychological Safety in Emergency Department–Based Pediatric Psychiatric Research: Lessons Learned

    Muhammad Waseem, Lincoln Medical Center

  77. 6:30 PM

    60 min

    Poster · Miscellaneous

    Reduce, Reuse, Recycle: Making Research More Sustainable

    Kaiyang Zhu, Emory University School of Medicine

  78. 6:30 PM

    60 min

    Poster · Decentralized Clinical Trials

    Remote Biospecimen Collection in Decentralized Clinical Trials: Vendor Models, Operational Complexity, and Hidden Site Workload

    Danielle Shrader, Mayo Clinic

  79. 6:30 PM

    60 min

    Poster · Pediatrics

    Research Nurse-Led Use of Artificial Intelligence to Create a Low-Cost Animated Educational Video Supporting Pediatric Research Consent and Assent Discussions: A Human-Reviewed Proof of Concept

    Diana Martin, Stanford University

  80. 6:30 PM

    60 min

    Poster · Miscellaneous

    Revised Startup Pipeline for Subject Payments

    Maurice Chojecki, University of Michigan

  81. 6:30 PM

    60 min

    Poster · Site Management

    Risk-Based Feasibility and Operational Readiness in Cell Therapy Clinical Trials

    Brooke Leibfreid, University of Cincinnati

  82. 6:30 PM

    60 min

    Poster · Monitoring Effectiveness

    Risk-Based Monitoring Plan for Multi-Centered Clinical trials: Workflows and Outcomes

    Jordan King, Feinberg School of Medicine

  83. 6:30 PM

    60 min

    Poster · Site Management

    Screening Failure in Phase I Oncology Clinical Trials: A Structured Literature Review of CRC-Actionable Strategies for Improving Patient Enrollment

    Noriko Kobayashi, National Cancer Center Hospital

  84. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    Sponsored Transportation Support: A Strategy to Enhance Study Visit Compliance and Participant Retention in Clinical Trials

    Sridevi Kotha, Dell Seton Medical center at the Unversity of Texas at Austin

  85. 6:30 PM

    60 min

    Poster · Data Management

    Standardization and Optimization of Helpdesk Inquiry Responses through Knowledge Sharing and Ai Utilization in a Redcap Helpdesk

    HIsako Fujii, Osaka Meropolitan University Graduate School of Medicine

  86. 6:30 PM

    60 min

    Poster · Miscellaneous

    Streamlining Prescreening for Phase I Oncology Trials: A Two-Year Follow-Up Analysis

    Laura Hurley, University of Michigan

  87. 6:30 PM

    60 min

    Poster · Project Management

    Streamlining the Ancillary Review Process

    Amanda Heater, Clinical Research Coordinator

  88. 6:30 PM

    60 min

    Poster · Data Management

    Tableau-Driven Continuous Data Reconciliation to Optimize Strap Data Quality

    Susan Hmwe, City of Hope National Medical Center

  89. 6:30 PM

    60 min

    Poster · Project Management

    The Cost of “Everyone Knows That”

    Amy Porter, Texas Biomedical Device Center at The University of Texas at Dallas

  90. 6:30 PM

    60 min

    Poster · Training

    The Impact of a Collaborative Education Series on Clinical Research Teams

    Tina Nghiem, AstraZeneca Pharmaceuticals

  91. 6:30 PM

    60 min

    Poster · Miscellaneous

    The Spotlight on Quality Program Implements brief, Targeted Quality Spot Checks across Active Clinical Trials. These Reviews Will Focus on Critical Study Activities and Documentation that Have the Greatest Impact on Subject safety, Data integrity, and…

    Monica Treta, Carl & Edyth Lindner Center for Research & Education at The Christ Hospital

  92. 6:30 PM

    60 min

    Poster · Enrollment/Retention & Informed Consent

    The Value of Nursing Expertise in Clinical Trials: Clinical Judgment as a Research Asset in a Large Academic Oncology Program

    Kayee Tung, Princess Margaret Cancer Center

  93. 6:30 PM

    60 min

    Poster · Training

    Training the Monitor: Equipping Clinical Research Associates to Advance Diversity in Clinical Trials

    Janet Brantley, Solveau Clinical Partners, LLC

  94. 6:30 PM

    60 min

    Poster · Miscellaneous

    Trials in Motion: The Inspection Stability Framework for Qa Systems that Hold under Pressure

    Wijdan Suliman, Holistinova research

  95. 6:30 PM

    60 min

    Poster · Regulatory

    Understanding the Training Burden Among Clinical Research Professionals at the University of Vermont Cancer Center

    Krishna Patel, UNIVERSITY OF VERMONT

  96. 6:30 PM

    60 min

    Poster · Pediatrics

    Utilizing a Visual 1- page form to Support Informed Decision-Making in a Pediatric Randomized Controlled Trial

    Jasmine Parker, CCHMC

  1. 11:00 AM

    60 min

    Keynote · Plaza Ballroom

    Attributable, Accountable, Auditable: Responsible AI Governance in Clinical Research

    Merage Ghane, Coalition for Health AI

  2. 1:15 PM

    45 min

    Talk · Device Research · Governor's Square 11

    From State of the Art (SOTA) Literature Search to Device Claims: Building a Defensible Clinical Evidence Strategy

    Barbara Fink, Heartstream

  3. 1:15 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Modernizing Research Funds Flow: Practical Tools to Improve Billing and Reimbursement at the Site Level

    Shreya Singh, Huron Consulting Group Eric Tomasini, Huron

  4. 1:15 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    Paperless Transition to eRegulatory Binders: The Onboarding & Lessons Learned

    Jenny Nguyen, Henry M. Jackson Foundation

  5. 1:15 PM

    45 min

    Talk · Inclusion Diversity Equity Access (IDEA) in Clinical Research Behavior · Governor's Square 12

    Patient Centered Research: From Principles to Practice in Effective Communication—Equitable Access, Informed Consent, and AI

    Michelle Medeiros, University of Maryland Baltimore

  6. 1:15 PM

    95 min

    Poster · Governor's Square 15

    Poster Oral Presentations

    Maurice Chojecki, University of Michigan Mohamed Iburahim Haja Maideen, The University of Chicago Lydia Mercado, Mayo Clinic Danielle Shrader, Mayo Clinic Jasmine Parker, CCHMC Jennifer Marino, University of California Krishna Patel, UNIVERSITY OF VERMONT Stacee Naylor, The University of MS Medical Center Kelsey Lewis, St. Jude Children's Research Hospital

  7. 1:15 PM

    45 min

    Talk · Investigator Initiated Research · Governor's Square 16

    Quality Assurance in Investigator Initiated Research

    Sarah Teague, Atrium Health Wake Forest Baptist Comprehensive Cancer Center Cecilia Flynn, Advocate Health Wake Forest Baptist Comprehensive Cancer Center

  8. 1:15 PM

    45 min

    Talk · Data Management · Governor's Square 17

    The Role of Data Coordination Centers in Regulatory Compliance

    Crystal Santillanes, Feinberg School of Medicine Luke Rasmussen, Northwestern University

  9. 2:05 PM

    45 min

    Talk · Data Management · Governor's Square 17

    Applying Project Management Principles for Data Management Projects

    Kolanda Ackey, St Jude Children's Research Hospital/Global Pediatric Medicine

  10. 2:05 PM

    45 min

    Talk · Inclusion Diversity Equity Access (IDEA) in Clinical Research Behavior · Governor's Square 12

    Building Trust and Participation in Safety Net Hospital Systems

    Latrisha Horne, Morehouse School of Medicine

  11. 2:05 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Mitigating Investigational Product Administration errors: An Sop and Qa Proposal.

    Carolynn Jones, The University of Alabama At Birmingham

  12. 2:05 PM

    45 min

    Talk · Device Research · Governor's Square 11

    One World, Many Regulations: Harmonizing Regulatory Strategy across Borders

    Laura Ann Green, Edwards Lifesciences

  13. 2:05 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    Optimizing Protocol Amendment and Regulatory Workflows in Clinical Trials: An Fda-Informed Approach

    Ramya Krishna Chunduru, Independent Researcher

  14. 2:05 PM

    45 min

    Talk · Investigator Initiated Research · Governor's Square 16

    Reframing Investigator Initiated Research: Aligning Support, Oversight, and Innovation with ICH E6(R3)

    Nancy Wintering, Marcus Institute of Integrative Health, Thomas Jefferson University

  15. 3:25 PM

    45 min

    Talk · Data Management · Governor's Square 17

    ClinicalTrials.gov Compliance for Busy PIs & CRCs: Mastering FDAAA 801, 42 CFR Part 11, and NIH Requirements

    Susan Hmwe, City of Hope National Medical Center

  16. 3:25 PM

    45 min

    Talk · Miscellaneous · Governor's Square 11

    Human-Centered Leadership in Clinical Research

    Jessica Fritter, The Ohio State University

  17. 3:25 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    IRB Reportability Lab: Sharpening RNI Assessment through Real Scenarios

    Jessica Rowe, Yale University Amy Pace, Yale University School of Medicine

  18. 3:25 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Investing in Infrastructure: How Training, Quality, and Unfunded Research Build Trial‑Ready Teams

    Michelle Faust, Cincinnati Children's Hospital Medical Center Devan Vaughn, Cincinnati Children's Hospital Medical Center

  19. 3:25 PM

    45 min

    Talk · Investigator Initiated Research · Governor's Square 16

    Monitoring Investigator-Initiated Studies: Trends, Challenges, and Mitigation Strategies

    Giselle Sesteaga, Miami Cancer Institute - Baptist Hospital

  20. 3:25 PM

    45 min

    Talk · Inclusion Diversity Equity Access (IDEA) in Clinical Research Behavior · Governor's Square 12

    Strategies to Improve Access and Enrollment in Community-Based Clinical Research

    Lawrence Matarutse, Northshore Research Associates LLC

  21. 4:15 PM

    45 min

    Talk · Miscellaneous · Governor's Square 12

    Bridging the Digital Divide: Equitable Oversight across All Sites

    Catherine Gregor, Florence Healthcare

  22. 4:15 PM

    45 min

    Talk · Miscellaneous · Governor's Square 11

    Building the Next Generation of Clinical Research Professionals

    Jessica Fritter, The Ohio State University Samantha Martinek Bundt, The Ohio State University

  23. 4:15 PM

    45 min

    Talk · Data Management · Governor's Square 17

    CTCAE v6.0: Key Updates and Clinical Implications

    Ashley Bruns, Medstar Georgetown Transplant Institute

  24. 4:15 PM

    45 min

    Talk · Investigator Initiated Research · Governor's Square 16

    Measuring What Matters: A Practical Framework for Quantifying the Impact of Research Support

    Nicole Tosun, The University of Minnesota

  25. 4:15 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    Milestones and Missteps: The History of Research Regulations

    Laura Adkins, UAMS

  26. 4:15 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Reframing Clinical Trial Site Benchmarking: From Metrics to Meaningful Alignment

    Andrea Bastek, Florence Healthcare

  1. 8:30 AM

    45 min

    Talk · Regulatory · Governor's Square 12

    Driving Regulatory Excellence and Audit Readiness: Implementing a Multi-Prong Quality Improvement Framework to Strengthen Centralized Regulatory Operations

    Pukar Ratti, Baylor Scott & White Health Richard Vargas, Baylor Scott & White Health

  2. 8:30 AM

    45 min

    Talk · Regulatory · Governor's Square 17

    How in Vivo Generated CAR T Cells and in Vivo Gene Editing Will Affect Oncology, Autoimmunity, and Rare Disease Research

    Daniel Eisenman, Advarra

  3. 8:30 AM

    45 min

    Talk · Site Management · Governor's Square 10

    Making Site Identification and Feasibility Functional between Sites and Cros

    Marlenie Moodie, Parexel

  4. 8:30 AM

    45 min

    Talk · IRB · Governor's Square 16

    Managing Research Participant Complaints in Phase I Units: Practical Tools for Clinical Research Professionals

    Marilyn Eshikena, Salus IRB Marcy Goodfleisch, Salus IRB

  5. 8:30 AM

    45 min

    Talk · Regulatory · Governor's Square 14

    Practical Applications of AI for Regulatory Management in Clinical Research

    Arian Karimitar, BIDMC - Harvard Medical School Affiliated

  6. 8:30 AM

    45 min

    Talk · Training · Governor's Square 11

    Stronger Teams, Better Results: The Enneagram in Clinical Research

    Carolina Cunha, CK Coaching

  7. 9:20 AM

    45 min

    Talk · Project Management · Governor's Square 15

    Behind the Numbers: Demystifying Clinical Trial Budgets

    Rebecca Schneider, University of Missouri

  8. 9:20 AM

    45 min

    Talk · Pediatrics · Governor's Square 16

    Building a High-Reliability Informed Consent Process in Pediatric Clinical Research

    Shannon Chism, Huron Consulting Group Brandi Scott, Children's Hospital Los Angeles

  9. 9:20 AM

    45 min

    Talk · Site Management · Governor's Square 10

    Clinical Trial Activation: Process Evaluation and Successful Change Management

    Erin Lynch, Medical College of Wisconsin Cancer Center

  10. 9:20 AM

    45 min

    Talk · Decentralized Clinical Trials · Governor's Square 17

    Designing for Distance: Key Operational Considerations in Decentralized Trial Design

    Robert Raske, Mayo Clinic

  11. 9:20 AM

    45 min

    Talk · Regulatory · Governor's Square 14

    Guidelines Needed for the Use of Ai in the Preparation or Review of IRB, IBC, and Iacuc Applications

    Daniel Eisenman, Advarra James Riddle, Advarra

  12. 9:20 AM

    45 min

    Talk · Training · Governor's Square 11

    Research Remix: Reimagining Team Training through Play, Creativity, and Applied Practice

    Lauren Koehler, Wake Forest University School of Medicine

  13. 9:20 AM

    45 min

    Talk · Regulatory · Governor's Square 12

    Turning Obstacles into Opportunities

    Jessica Rowe, Yale University

  14. 10:50 AM

    45 min

    Talk · Decentralized Clinical Trials · Governor's Square 17

    Building Rural Access to Clinical Trials: Implementation Lessons from a Research Readiness Model

    Mary Christie, University of Missouri Veronica Lemme, University of Missouri

  15. 10:50 AM

    45 min

    Talk · Site Management · Governor's Square 10

    From Startup to Sustainability: The New Reality of Research Site Operations

    Alyssa Gateman, Yale Cancer Center Sandy Smith, WCG Clinical

  16. 10:50 AM

    45 min

    Talk · Monitoring Effectiveness · Governor's Square 12

    Optimizing Monitoring Effectiveness in a Large Multi-Site Trial: Lessons from Sdv Backlog to Fda Audit Readiness

    Angela Robinson-Brown, ThermoFisher Scientific

  17. 10:50 AM

    45 min

    Talk · Enrollment/Retention & Informed Consent · Governor's Square 16

    Protecting Vulnerable Patients in Oncology Trials: Enhancing Informed Consent and Ethical Safeguards

    Elena Alferova, UCSD Moores Cancer Center

  18. 10:50 AM

    45 min

    Talk · Training · Governor's Square 11

    Responsible Conduct of Research during Crises: A Practical Framework for Preparedness

    Muhammad Waseem, Lincoln Medical Center

  19. 10:50 AM

    45 min

    Talk · Miscellaneous · Governor's Square 15

    The Power Pair: Regulatory + Clinical Development as Catalysts for Rapid, Compliant Growth

    Brianna Phillips, Biodesix, Inc. Niki Givens, Biodesix

  20. 10:50 AM

    45 min

    Talk · Miscellaneous · Governor's Square 14

    Top Findings in Fda Warning Letters to Clinical Investigators

    Annette Oeser, Vanderbilt University Medical Center HRPP

  21. 11:40 AM

    45 min

    Talk · Site Management · Governor's Square 10

    Building Access-Ready Clinical Trial Sites: An Operational Framework to Improve Enrollment Performance.

    Rachana Kanvinde, Arusha Strategies

  22. 11:40 AM

    45 min

    Talk · Decentralized Clinical Trials · Governor's Square 17

    Cross-Border Clinical Trials in a Digital Era: Cybersecurity, Privacy, and Patient Trust

    Poonam Jani, Frontier Science Foundation Tejas Jani, Amazon

  23. 11:40 AM

    45 min

    Talk · Training · Governor's Square 11

    Developing GenAI Guidelines to Support CRCs and Medical Researchers Facing Burnout

    Amrita Ghosh, Stanford University School of Medicine

  24. 11:40 AM

    45 min

    Talk · Pediatrics · Governor's Square 16

    From Sirens to Science: Conducting Multicenter Clinical Research in Emergency Medical Services (EMS)

    Kammy Jacobsen, University of Utah Brittany Brown, University of Utah Data Coordinating Center

  25. 11:40 AM

    45 min

    Talk · Project Management · Governor's Square 15

    Managing Multiple Studies: What’s the plan?

    Maryam Masood, Massachusetts General Hospital

  26. 11:40 AM

    45 min

    Talk · Miscellaneous · Governor's Square 14

    Should Clinical Researchers Worry about Artificial Intelligence? a Framework for Responsible Integration

    Muhammad Waseem, Lincoln Medical Center

  27. 1:40 PM

    45 min

    Talk · Project Management · Governor's Square 15

    Bridging Disciplines: Using the Project Management Frameworks to Communicate Clinical Trials to Leadership and Expedite Study Start-Up and Execution

    Sylvia Caldwell, Augusta Health Lisa Lenker, Augusta Health Center for Cancer & Blood Disorders

  28. 1:40 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Building Effective CAPA Programs in Clinical Research

    Asma Khan, Stanford Cancer Institute

  29. 1:40 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    FDA Inspections: Handling the Consequences

    Janet Holwell, Holwell Clinical Research Consulting

  30. 1:40 PM

    45 min

    Talk · Enrollment/Retention & Informed Consent · Governor's Square 16

    Improving Clinical Trial Enrollment in Underserved, Rural, and Tribal Communities: Clinician-Driven and AI-Enabled Approaches

    Christine Lee, Achieve Tim Mackey, S-3 Research

  31. 1:40 PM

    45 min

    Talk · Monitoring Effectiveness · Governor's Square 12

    Monitoring: Oversight with Impact

    Laura Adkins, UAMS

  32. 1:40 PM

    45 min

    Talk · Training · Governor's Square 11

    Next‑Gen Clinical Research Training: Novel Methods for Delivering Core Principles with Impact

    Katrina Croghan, St. Cloud State University

  33. 1:40 PM

    45 min

    Talk · Miscellaneous · Governor's Square 17

    What 100+ Real Prompts Taught Me about Using AI in Clinical Research

    Titilayo Olubajo, Houston Methodist

  34. 2:30 PM

    45 min

    Talk · Miscellaneous · Governor's Square 12

    483s, Now What? - Turning Observations into Action

    Majagamy Ramos-Bordonaro, Alliance Foundation Trials

  35. 2:30 PM

    45 min

    Talk · Training · Governor's Square 15

    Budget and Feasibility Basics: What Coordinators Need to Know

    Robin Kuprewicz, Georgetown University

  36. 2:30 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    FDA Flexibility in Drug Development: What Clinical Research Professionals Need to Know

    Sarah Wicks, Hyman

  37. 2:30 PM

    45 min

    Talk · Enrollment/Retention & Informed Consent · Governor's Square 16

    Lessons Learned from the Use of a Stakeholder Engagement Framework to Inform the Identification of Leading Indicators for Clinical Research Enrollment Performance: The VA Clinical Research Enrollment Summit

    Marcus Johnson, Durham VA Medical Center Margaret Tiktin, VA Cleveland Northeast Ohio Healthcare System

  38. 2:30 PM

    45 min

    Talk · Decentralized Clinical Trials · Governor's Square 17

    MNCCTN: The Difficulties and Advantages of Multi-Institutional Trials

    Denise Windenburg, University of Minnesota

  39. 2:30 PM

    45 min

    Talk · Project Management · Governor's Square 11

    Risk and Quality Management Aligned with Ich E6(R3)

    Amy Selegue, Caris Life Sciences Trevor Cole, Diligent Pharma

  40. 2:30 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Site‑First Start‑Up to Sustained Enrollment: SOPs, Workflows & Retention for Private Practice

    Brenda Whitehead, Sibyl Wray

  41. 3:45 PM

    45 min

    Talk · IRB · Governor's Square 16

    A Tale of Two IRBs: Conflicting Ethical Considerations in Waivers of Consent

    Annette Oeser, Vanderbilt University Medical Center HRPP

  42. 3:45 PM

    45 min

    Talk · Project Management · Governor's Square 15

    Beyond Task Lists: Data-Driven Project Management for Clinical Research

    Arian Karimitar, BIDMC - Harvard Medical School Affiliated

  43. 3:45 PM

    45 min

    Talk · Monitoring Effectiveness · Governor's Square 12

    Discovering the Synergy of Auditing and Monitoring

    Abby Statler, AVEO Pharamceuticals, Inc.

  44. 3:45 PM

    45 min

    Talk · Regulatory · Governor's Square 14

    Redefining Sponsor–Site Partnerships in the Era of ICH E6 (R3)

    Susan Hmwe, City of Hope National Medical Center Rachel Kingsford, Huntsman Cancer Institute

  45. 3:45 PM

    45 min

    Talk · Training · Governor's Square 11

    Training Clinical Research Professionals: A Competency Based Approach to Workforce Readiness and Retention

    Allison Poore, University of Colorado Timothy Michael, University of Colorado Cancer Center

  46. 3:45 PM

    45 min

    Talk · Miscellaneous · Governor's Square 17

    Trials in Transition: Navigating Hhs Policy Shifts in 2026

    Catherine Gregor, Florence Healthcare

  47. 3:45 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Turning Conflict into Clarity: The Art of Crucial Conversations

    Laura Adkins, UAMS

  48. 4:35 PM

    45 min

    Talk · Monitoring Effectiveness · Governor's Square 12

    Close the Loop: How Relationship‑Driven Monitoring Improves Effectiveness from Study Start‑Up Through Execution

    Shanell Laner, Stryker

  49. 4:35 PM

    45 min

    Talk · Project Management · Governor's Square 15

    From Backlogs to Benchmarks: Applying Agile Metrics to Modernize Clinical Research Operations

    Laura Holtz, Indiana University Casey Snoddy, IUSM

  50. 4:35 PM

    45 min

    Talk · Site Management · Governor's Square 10

    Plot Twists Welcome: How Non‑Linear Career Stories Shape a Stronger Research Workforce Library

    Lauren Koehler, Wake Forest University School of Medicine

  51. 4:35 PM

    45 min

    Talk · Miscellaneous · Governor's Square 14

    Solving the Clinical Research Problem: A Journey Back to the Basics

    Quincy Byrdsong, Ballad Health

  1. 8:40 AM

    45 min

    Keynote · Plaza Ballroom

    AI-Powered Clinical Trials for Longevity

    Alla Sergueeva, Let's Prolong Life with AI

  2. 9:25 AM

    45 min

    Keynote · Plaza Ballroom

    Clinical Research in Today’s Policy Landscape: What’s Happening and why Your Voice Matters

    Erin Darbouze, Research!America

  3. 10:30 AM

    45 min

    Keynote · Plaza Ballroom

    Prepare. Present. Prevent. A Community-Centered Framework for Building Trust in Clinical Research

    Breana Turner, Becoming HealthyHer

Speakers

Reviews

No reviews yet

Were you there? Reviews are open until Sep 27, 2027.

Write the first review