This package is a replay of 92 on-demand session recordings and presentation slides from the ACRP 2026 Conference, April 24 – 27, Orlando, Florida. It includes content from the five educational tracks, the Signature Series sessions, and sponsored sessions, presented by a variety of clinical research service providers.
Member: $499 | Nonmember: $699
Participants can earn up to 24 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Learning Portal.
For years, the clinical research industry has pursued transformative changes—seeking smarter trials, more efficient processes, and improved patient outcomes. Today, those long-awaited advancements are no longer aspirational—they’re happening. From decentralized trials and AI-driven insights to streamlined protocols and enhanced patient engagement, the future of clinical research is unfolding in real time. Speakers: Barbara Bierer, Faculty Director, Harvard Medical School; Kevin Bugin, Associate Vice President of Global Regulatory Policy and Intelligence, Amgen; Rob DiCicco, Vice President of Portfolio Management, TransCelerate Biopharma Inc; Morgan Hanger, Executive Director, Clinical Trials Transformation Initiative; Jennifer Byrne, Chief Executive Officer and Board Director, Javara (Moderator)
Clinical research is a dynamic field shaped by the people who plan, conduct, and oversee it at every career stage. This engaging panel brings together diverse voices to share their career journeys, the leadership skills that fueled their growth, and the pivotal moments that defined their paths. Speakers: Michelle Rowe, RN, VP, Research, HCA Healthcare; Jennifer Sheller, ACRP-CP, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck; Muriel Maignan Wilkins, CEO & Founder, Paravis Partners; Susan P. Landis, Chief Executive Officer, Association of Clinical Research Professionals (Moderator)
Clinical research is undergoing a dynamic transformation—propelled by breakthrough developments, evolving regulations, and fresh approaches to collaboration. David Burrow will offer strategic insights on elevating trial quality and minimizing regulatory uncertainty—sharing forward-thinking approaches and practical tools designed to help research professionals thrive in today’s complex and rapidly shifting environment. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, U.S. Food and Drug Administration
Back by popular demand and reimagined for 2026, the ACRP Game Show returns with more energy, more surprises, and more chances to test your knowledge in this high-energy session. Teams of clinical research professionals will go head-to-head in a fast-paced trivia battle covering everything from ICH-GCP principles to eClinical technology, informed consent essentials, and more! Audience members won’t just watch—they’ll play along, cheer on their peers, and maybe even walk away with bragging rights. Whether you’re a seasoned expert or a curious newcomer, this session is your chance to learn, laugh, and celebrate the clinical research enterprise in a whole new way. Speakers: Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen; Lexi Herbert, Launch Manager, TrialScreen
This dynamic session explores the complexities and opportunities of conducting clinical research outside the United States. Through real-time polling, interactive Q&A, and scenario-based reflection, attendees will gain practical insights into regulatory, cultural, and operational differences across global regions. The session will equip clinical research professionals with tools and strategies to confidently engage in multinational trials, while promoting inclusion, equity, and global collaboration. Speaker: Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy
As clinical research grows more complex and data-driven, patient-centered risk management is essential to designing resilient trials. This panel explores a holistic, ICH E6(R3)-aligned approach that embeds risk mitigation across the trial lifecycle while prioritizing patient needs, safety, and experience. Panelists will share real-world examples of how inclusive protocol design and patient advisory input during early planning reduce risk by improving accessibility, engagement, and retention. In startups, automated site selection and harmonized regulatory workflows minimize delays and variability, accelerating patient access. Artificial intelligence-based image sharing and interpretation require validated, explainable models and human oversight as key risk mitigation strategies to safeguard outcomes. Predictive analytics, risk-based monitoring, and centralized oversight tools help identify early warning signals and enable timely intervention. By embedding holistic risk mitigation with patient-centered operational strategies, innovation, and oversight, this session highlights how to build trials that are not only compliant and efficient, but also resilient and responsive. Speakers: Lourdes Carhuapoma, PhD, CRNP, Director, Participant-Centered Research Integrity and Risk, Johns Hopkins University, BIOS Clinical Trials Coordinating Center; Lindsay Eyzaguirre, MS, Assistant Professor, Johns Hopkins University School of Medicine; Clinical Coordinating Center Director, BIOS CTCC; Project Lead, Johns Hopkins University Trial Innovation Center (JHU TIC), Johns Hopkins University, BIOS Clinical Trials Coordinating Center; Karen Lane, CCRP, Assistant Professor of Neurology, Johns Hopkins University Deputy Director, BIOS Clinical Trials Coordinating Center Director, Multicenter Study Operations Training Program, ICTR MPI, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center; Andrew Mould, MPH, Assistant Professor, Department of Neurology; Data Coordinating Center Director, BIOS CTCC; HEAL Director, JHU SSRC HEAL Pain ERN; Assistant Director, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center
Clinical research teams manage millions of data points and thousands of documents—yet many still rely on manual, time-consuming processes that slow progress and increase risk. The good news: There are accessible AI and automation tools within your office suite that can significantly streamline everyday tasks. Join experts in clinical research operations as they share practical use cases, share insights, and discuss how you can build confidence and expertise in this rapidly changing field. Specific topics include reducing the AI fear factor, building an AI-informed workforce, and tackling clinical research operations with AI. Speakers: Burak Aktan, Head of Business Operations, Clinical Sciences and Study Management, Merck; Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus; Andrew Gordesky, Regional Director, Clinical Quality Management Latin America, Merck; Sandra Koseoglu, Director/ Program Lead, Clinical Sciences and Study Management, Merck; Chelsea Osterman, MD, Executive Medical Director, Tempus AI; Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, Merck; Jennifer Sheller, ACRP-CP, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck; Karen Strat, PhD, Clinical Scientist, Merck
This session will explore the critical role of Data Management (DM) in coordinating database lock activities across key stakeholders, including sites, sponsors, clinical operations, vendors, and biostatistics. A smooth database lock is vital to ensure data integrity and timely study reporting. From the DM perspective, we will outline the end-to-end process, emphasizing proactive planning, clear communication, and the use of customized tools that streamline collaboration and mitigate delays. Strategies such as freeze readiness checklists, data reconciliation trackers, and query management processes will be discussed to illustrate how efficiencies can be built into the process. By the end of this session, attendees will understand common pitfalls and effective solutions, as well as approaches to deliver an on-time and accurate database lock. Speaker: Abby Loden, MPH, Lead Data Manager, TRiNDS LLC.
Protocol deviations, if not properly identified and addressed, can jeopardize participant safety, data integrity, and trial credibility. The FDA’s December 2024 draft guidance on “Protocol Deviations for Clinical Investigations” introduces clearer expectations around assessing, categorizing, and reporting deviations, especially those deemed “important.” This session will provide attendees with a practical framework to align their practices with the evolving regulatory landscape. Through real-world case scenarios and an interactive exercise, participants will learn how to evaluate deviations using a risk-based approach and strengthen communication with institutional review boards and sponsors. We will also analyze emerging tools, including automation and artificial intelligence, that support proactive deviation detection and inspection readiness. Designed for clinical operations teams, site staff, and quality assurance professionals, this session combines compliance essentials with forward-looking strategies. Speakers: Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training; Meghana Rao, Sr. Manager, Clinical Trial Lead, Olema Oncology; Kaushal Shah, PhD, Director & Clinical Associate Professor, Clinical Research Management & Regulatory Science Programs, Arizona State University
The value of engaging non‑traditional and emerging sites is widely recognized, yet many of these sites continue to be overlooked due to a lack of prior trial experience. This creates a persistent cycle: sites struggle to build experience without access to studies, while sponsors often prioritize experience when selecting sites—ultimately limiting broader representation in clinical trials. With funding from Roche | Genentech, Duke Clinical Research Institute, and National Medical Fellowships, and support from Continuum Clinical, ACRP and its collaborators will share preliminary findings from qualitative interviews with sponsors and non‑traditional sites. These insights highlight real‑world barriers to participation in Phase III studies. Attendees will gain practical insight into how rethinking site selection—and more intentionally engaging non‑traditional sites—can support stronger recruitment outcomes while advancing meaningful representation. Speakers: Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech; Laveina Dash, Director, Doctors in Clinical Trials Research (NMF DCTR), National Medical Fellowships; Pete Fronte, MBA, President & CEO, Altura; Karen Lipworth, Communications Strategist and Senior Medical Writer, ACRP; Kathy Mickel, Director of Membership & Programs, Society for Clinical Research Sites; Susan P. Landis, Chief Executive Officer, ACRP (Moderator)
Decentralized clinical trials are reshaping how research is conducted, offering new opportunities to expand access, improve participant accrual, and reduce the burden on limited organizational resources. This session will explore transformative approaches institutions can take to implement and manage decentralized trials effectively. Attendees will learn how to adopt flexible models that support research growth without requiring extensive staffing or infrastructure. The session will highlight practical strategies for integrating decentralized elements into existing workflows, including virtual visits, digital tools, and participant-centered processes. Real-world examples will show how organizations have successfully used decentralized models to reach underserved populations and streamline operations. Whether the organization is beginning to explore decentralized research or looking to scale existing efforts, this session will provide actionable insights to help align trial design with institutional goals. Attendees will discover how decentralized research can be a powerful tool for increasing efficiency, expanding reach, and supporting sustainable research operations. Speaker: Shreya Singh, Consulting Sr. Associate, Huron Consulting Group
Study startup delays represent a critical barrier impairing efficiency in clinical research timelines and our ability to ultimately serve patients. Tackling each contributing factor in this issue should be an effort we all engage in. The Site-Sponsor Consortium—a unique collaboration of sponsors, contract research organizations, institutional sites, and commercial sites—will unveil its inaugural whitepaper, which details actionable strategies to simplify and harmonize Confidentiality Disclosure Agreement processes across the industry. Consortium members will discuss the operational and ethical imperatives for reform, the value of master and bilateral agreements, and the collaborative journey that led to consensus-driven solutions. Attendees will gain insight into the practical steps needed to reduce study startup timelines and foster a culture of shared responsibility, transparency, and innovation in clinical research. Speakers: Carlos Orantes, Chief Executive Officer, Alcanza Clinical Research; Michelle Rowe, RN, VP, Research, HCA Healthcare; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra; Brandi Walker, Executive Vice President, Clinical Development Operations, Syneos Health
Strong collaboration between contract research organizations (CROs) and study sites is essential for reducing trial delays, improving data quality, and accelerating patient access to new therapies. This panel, designed for clinical research professionals in operations, monitoring, study startup, and site roles, explores how intentional collaboration between CROs and study sites can drive measurable improvements in operational efficiency and data quality. Panelists will share real-life case studies and practical examples that highlight strategies for streamlining study startup, reducing rework, and building trust. Attendees will gain forward-thinking insights and walk away with actionable tips, tools, and processes to strengthen site-CRO relationships and enhance trial success. Join us to explore how shifting from reactive problem-solving to proactive partnership can transform site-CRO relationships into high-impact alliances that advance research and patient care. Speakers: Elizabeth Feathers, Clinical Operations Supervisor, Study Startup, CIBMTR; Kassandra Nealon, BS, Clinical Operations Manager, CIBMTR
Clinical trial recruitment often fails not because patients do not exist, but because they are never identified. Specialty private practices hold large, underutilized patient populations, yet recruitment strategies still rely on static feasibility surveys and manual chart review. This session introduces a data-driven approach that begins with a retroactive audit of existing patient records to quantify true trial feasibility, followed by real-time identification of eligible patients directly within clinical workflows. By structuring both structured and unstructured EHR data, sites can surface eligible patients continuously without manual effort. Using real-world deployments, we will show how this model replaces guesswork with measurable patient availability, reduces screening burden, and enables faster, more predictable enrollment. The result is a shift from reactive recruitment to a continuous system aligned with how care is actually delivered. Sponsored by Syntra. This session does not provide ACRP Contact Hours. Speakers: Ayush Jain, Co-Founder and CEO, Syntra; Eshanika Urs, Founding GTM, Syntra
Research teams are being asked to do more with less—especially when it comes to unfunded or underfunded studies. Whether it’s supporting investigator-initiated trials with no startup budget or absorbing hidden costs from sponsor studies, the financial strain is real. This session offers practical strategies for identifying and managing financial risk at the site level. We’ll walk through tools for feasibility screening, cost recovery, and portfolio-level decision-making. Attendees will leave with insights they can use to engage investigators and institutional leaders in honest conversations about what it really costs to “just get it done.” Speaker: Shannon Chism, Education & Research Consulting Sr. Director, Huron Consulting Group
Informed consent is a cornerstone of ethical research, but without accounting for health literacy, it often fails to ensure true participant understanding. This session will explore how research professionals can bridge the gap between regulatory compliance and meaningful comprehension, particularly in sensitive fields like reproductive health. Drawing from real-world experience in Phase III trials, biorepository studies, and community health research, I will share practical strategies for improving the consent process using plain language, teach-back methods, and visual aids. We’ll also examine relevant ICH-GCP guidelines, including the requirement that consent information be presented “in a language understandable to the subject,” and discuss how these principles apply in daily research practice. Attendees will leave with actionable tools to support participant-centered communication and to elevate the informed consent process beyond a signature to a personal, nuanced, and regulatory-compliant conversation that leaves patients feeling empowered in their decision. Speaker: Gianna Gemignani, BS, ACRP-CP, Clinical Research Project Coordinator, University of Wisconsin-Madison School of Medicine and Public Health (Department of OB/GYN)
Learn a values-based framework to standardize budgets while honoring site needs, empowering advocacy, equity, and site sustainability. Speaker: LaTisha Weaver, Consultant – CEO, LDM Clinical Research Source
Clinical research can be made more trustworthy and accessible by engaging communities through unconditional, literacy-driven outreach. This session shares a model for engaging people where they are, not as future participants or workforce members, but as community members deserving of clarity, inclusion, and respect. Presenters will share examples of how they deliver plain-language education about clinical research, facilitate conversations around research mistrust, and equip communities with the tools to navigate research information and options. These efforts aren’t tied to active studies or enrollment; rather, they’re grounded in the belief that long-term public trust is built through repeated, agenda-free education. Attendees will walk away with replicable strategies for building community-facing literacy initiatives centered on equity, transparency, and relationship-building. Speakers: Addison Gumbert, Clinical Research Marketing Strategist, Premier Clinical Marketing; Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
Time to activation remains one of the most critical and challenging determinants of site performance in clinical research. Delays in startup don’t just slow enrollment; they impact investigator engagement, sponsor confidence, and long-term competitiveness. This session explores how organizational models, centralized, decentralized, and hybrid, shape activation timelines in real-world settings. Drawing on practical examples, we’ll examine why activation delays rarely stem from a single step, but from fragmented workflows, limited visibility, and unclear accountability across feasibility, budgeting, contracting, and review processes. Participants will learn when centralization can drive clarity and consistency, where decentralization adds value, and how high-performing organizations intentionally design hybrid models to balance efficiency with local expertise. Attendees will leave with a clearer understanding of the activation critical path, the role of parallel work, and the metrics that truly matter when building sustainable speed into study startup. Sponsored by Huron. This session does not provide ACRP Contact Hours. Speakers: Shannon Chism, Education & Research Consulting Sr. Director, Huron Consulting Group; Mindy Muenich, Education & Research Sr. Director, Huron
In the clinical research industry, the importance of cultivating strong, trusted relationships between sponsors, sites, and patients is widely acknowledged as a key factor for clinical trial success. However, building and nurturing these relationships can be more challenging than it may appear. Upon closer examination of the underlying issues reveals that communication barriers and a lack of mutual understanding between stakeholders often hinder trial efficiency. This session will explore how professionals with experience on both the site and sponsor side of clinical research are uniquely positioned to bridge the gap. By providing sponsors with valuable insights into site challenges and patient needs while simultaneously empowering sites to better understand the sponsor’s objectives, we aim to foster the right relationships necessary for effective collaboration. When executed correctly, this approach can improve recruitment and retention, ensure higher data quality, and ultimately lead to more successful trials. Speakers: Summer Borsack, Associate Clinical Research Associate, Merck; Doris Chang, Associate Clinical Research Associate, Merck
Whether you’re a coordinator worried about missing a detail, a site director focused on quality, or a sponsor looking for practical ways to help ease site burden, this session is for you. Hear directly from sites about how Peter The Protocol Reader, a practical AI assistant, is helping give time back each day. From quickly checking whether a medication is prohibited to streamlining preparation for a patient visit, Peter is helping teams work through everyday study questions faster and with less mental burden. You’ll also hear why sponsors like Merck are embracing Peter for their sites and what sponsors require when AI is used for their studies. Come see why hundreds of coordinators have Peter supporting their daily workflows and how you can get started. Sponsored by Peter the Protocol Reader. This session does not provide ACRP Contact Hours. Speakers: Haitham Abulaban, MBBS, CCRC, ACRP-PM, Founder and CEO, Lakeview Institute of Clinical Research; Rupi Bancil, Senior Vice President of Global Study Operations & Global Expansion, CareAccess; Sarah Branch, Sr. Global Trial Optimization Specialist (GTOS), Merck; Gloria Carlbert, CMA, CCRC, Bradenton Research; Justin Yang, MD, MPH, FACRP, FACOEM, Principal Investigator, CareAccess
This session proposes a new operational paradigm focused on redesigning the internal structure of clinical trial sites through the incorporation of specialized roles–with active support from the industry–to ensure quality, efficiency, and long-term sustainability. The presenter will analyze the structural limitations of the traditional site model and their implications for quality, compliance, and efficiency; demonstrate the strategic value of new key roles such as clinical trial managers, quality control specialists, quality assurance specialists, clinical trial educators, and clinical research coordinator assistants; present a scalable framework based on quality management systems (QMS) that integrates these roles; and offer an action plan to transform site structures and strengthen the workforce. Speaker: Carlos Pinoargote, Chief Operating Officer, BRCR Global
Engaging vulnerable populations in research requires careful consideration of ethical and practical challenges. Researchers must prioritize participants’ safety, privacy, and well-being while ensuring the research is meaningful and impactful for the community. This presentation will highlight real-world experiences, challenges, and practical solutions for involving vulnerable populations in research during trying times such as those we face now. It’s important to emphasize that additional protections should not deter researchers from involving these groups. Instead, such safeguards enable ethical inclusion, ensuring that individuals who may benefit most from research are not systematically excluded due to perceived risks or complexities. Speaker: Muhammad Waseem, MD, MS, Research Director, Emergency Medicine, Lincoln Medical Center
Federally Qualified Health Centers (FQHCs) are nonprofit organizations governed by patients that provide high-quality, comprehensive healthcare to medically underserved populations across the United States, regardless of income or insurance coverage. In 2023, FQHCs served 32.5 million patients, with 63% identifying as people of color. In North Carolina specifically, FQHCs serve more than 750,000 patients annually, with more than 60% of them being people of color. Despite this broad reach and impact, FQHCs remain an underutilized resource in clinical research. This session will explore how FQHCs can serve as decentralized clinical trial sites to expand access and address long-standing disparities in trial participation. The session will highlight insights from surveys and questionnaires completed by patients and FQHC care teams, share best practices for integrating clinical trials, and discuss the necessary infrastructure to support research within FQHCs. Speakers: Rebecca Hayes, MD, MEHP, Director of Research, North Carolina Community Health Center Association; Korrey Monroe, MPH, Research Program Manager, North Carolina Community Health Center Association; Mayra Overstreet Galeano, Chief Medical Officer, Community Faculty, Adjunct Assistant Professor, MedNorth Health Center, Novant Health, University of North Carolina at Chapel Hill; Peter Shin, PhD, MPH, Chief Science Officer, National Association of Community Health Centers
Delays in clinical trial budgeting often result not from lack of effort, but from a lack of shared understanding across stakeholders. Sites, sponsors, and contract research organizations each have different processes and constraints that create friction in this critical startup process. This session presents findings from a cross-industry working group that explored the root causes of budgeting misalignment and developed practical, stakeholder-informed strategies to close the gap. The group’s work centers on three key domains—study startup operations, budget estimation, and budget justification—and shares insights from real-world experiences across the research ecosystem. The goal is to accelerate study startup by building mutual understanding, streamlining communication, and promoting efficient negotiation. Attendees will walk away with actionable tools that can be used to upskill staff, improve cross-functional collaboration, and support an improved approach to budgeting in clinical research.
Speakers: Candida Barlow, PhD, MSN, CRN-BC, RN, Director Clinical Research, Oklahoma State University Center for Health Sciences; Andrea Bastek, Ph.D., VP of Market Strategy, Florence Healthcare; Heidi Castle, CCA, Director, Business Development, Mercy Research
Patient recruitment and retention can be enhanced by understanding patients, building strong relationships, and fostering a connected, engaged community. This session explores the paradigm shift from enrolling participants on a trial-by-trial basis to encouraging lifelong recruitment. Patients who feel part of a community and have strong relationships with sites are more likely to stay in studies and participate in future trials. The presenter will share strategies and tactics for turning the non-qualified leads–the hidden treasure for recruitment–into members of the patient community. Recruiting from this community is both efficient and cost effective. Through interactive polling and real-world case scenarios, this session demonstrates how a retention-first approach improves outcomes, reduces recruitment burden, and lowers costs. Attendees will leave with practical tools that they can apply immediately at their sites. Speaker: Anuj Bhargava, MD, MBA, CDCES, FACP, FACE, Founder, CEO & Medical Director, Iowa Diabetes
Bringing a novel implantable device from concept to human trials is daunting—doing it entirely within an academic setting, without commercial sponsorship, is almost unheard of. Our team successfully navigated the full translational pipeline: developing the device and treatment protocol, conducting rigorous preclinical testing, securing U.S. Food and Drug Administration (FDA) Investigational Device Exemption approval, and executing an early feasibility study, ultimately culminating in a Nature publication. This session provides a practical framework for managing operational complexity in sponsor-investigator trials. We will share actionable strategies for communication, regulatory preparedness, role delineation, and risk mitigation—focusing on the tools and practices that allowed our team to proceed with confidence. For academic institutions, startups, or research teams operating at the edge of innovation, this session offers grounded, replicable strategies for moving from concept to clinic—and highlights the operational systems we would never do without. Speaker: Amy Porter, PE, MBA, Director, Texas Biomedical Device Center at the University of Texas at Dallas
This highly interactive session will introduce participants to an innovative, multiculturally aware approach for advancing equitable and inclusive representation in clinical trials. We will share our journey in developing and piloting a novel engagement model, highlighting both the community-engaged design process and early findings from our pilot implementation. Participants will then engage in a hands-on activity that maps key inclusivity-driven strategies and frameworks from our model to their own work. By the end of the session, attendees will leave with practical, actionable tools to advance equity and racial justice in their clinical trial recruitment efforts. Speakers: Chaya Pflugeisen, MSc, MEd, Manager, Investigator Initiated Research, MultiCare Health System; Deana Williams, PhD, MPH, Research Investigator, MultiCare Health System
Patient recruitment remains a persistent challenge for sites in clinical trials. This presentation explores promising solutions and collaborative strategies to transform recruitment outcomes. Panelists will discuss how they are successfully leveraging patient recruitment solutions, financial and operational barriers, and how patient advocacy engagement can bridge the gap between sponsors, CROs, and patient populations—particularly in oncology and rare disease studies. Sponsored by Parexel. This session does not provide ACRP Contact Hours. Speakers: Leslie Ives, Senior Director, Patient Recruitment, Parexel; Joe Nadglowski, President and CEO, Obesity Action Coalition; Jeffrey Smyth, MS, President and Executive Director, TrueBlue Clinical Research
The clinical research enterprise often attracts the kind of perfectionists who feel crushed when they make mistakes. They take failure personally, and, in an industry where every “i” and “t” are quality checked, their shortcomings are always noticed. But, what if we could build a clinical research team that promotes inclusion, learning, expression, and contribution–a team whose members no longer wake up in the night wondering if they forgot a signature during the monitoring visit? This session will promote the values of psychological safety in the workplace and empower listeners to identify psychological safety principles and the impact on teams that lack them. Participants will be guided through real-life monitoring scenarios, learn what went right or wrong, and practice applying the four stages of psychological safety. Speakers: Amanda Egan, CCRP, Clinical Research Associate, Merck; Carli Lettrich, Senior Clinical Research Associate, Merck; Kyle Niquette, CCRA, Clinical Research Associate Manager, Merck
Utilization of Decentralized Clinical Trial (DCT) elements expanded rapidly during the COVID‑19 pandemic, when traditional research pathways were disrupted and remote participation became essential. After the pandemic, Sanford built on the operational and regulatory momentum gained to broaden both the scope and reach of its DCT program. This work continues through strong collaboration with key internal partners and external stakeholders, ensuring the program evolves to meet patient needs, regulatory expectations, and community priorities. Speaker: Lora Black, RN, MPH, OCN, ACRP-CP, Vice President of Clinical Research, Sanford Health
As the University of Alabama at Birmingham’s Clinical Research Support Enterprise (CReSt) expanded, traditional systems proved insufficient for managing the growing complexity of clinical trial operations. Determining trial costs became a focus, with a goal of implementing no-cost, scalable solutions that improved visibility across the trial lifecycle, empowered staff, and could be replicated by other institutions. The CReSt unit adopted a suite of open-source tools to develop platforms for managing such core trial functions as study startup, enrollment tracking, subject reimbursements, and automated reporting. These tools were created entirely by clinical research administrators without the support of an information technology team or professional developers. Crucially, generative artificial intelligence (AI) tools were used to build, debug, and refine these systems. These tools accelerated development and lowered the technical barrier for non-programmers to build impactful solutions. Speaker: Meredith Fitz-Gerald, RN, MSN, Clinical Research Support Enterprise Director – Education and Clinical Outreach, The University of Alabama at Birmingham
Participant payments, reimbursements, and compensation policies vary widely across sponsors, sites, and geographies—leading to confusion, inequity, and potential barriers to enrollment. This session will explore the current landscape of participant benefits in clinical trials and propose a framework for standardization that balances ethical, operational, and regulatory considerations. Drawing on real-world case studies, stakeholder feedback, and emerging policy trends, we will present actionable strategies to modernize and harmonize how we support trial participants—especially those from underrepresented communities. Speaker: Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, Merck
This presentation explores how engaging communities at every stage of clinical research builds trust, promotes informed participation, and enhances recruitment efforts. The presentation will discuss various strategies for involving communities during the design, implementation, and dissemination of research findings, highlighting their benefits and challenges related to cost, feasibility, and timing; as well as sharing examples of successful community engagement initiatives. Attendees will learn how to identify the most effective engagement approaches for their studies and the importance of early community involvement in ensuring ethical and impactful research. Speaker: Bashar Shihabuddin, MD, MS, Assistant Professor, Nationwide Children’s Hospital
What if the real obstacle to better recruitment isn’t your budget or your systems… but how you communicate? Too often, clinical teams overlook the role personality plays in how messages are delivered, received, and acted on in both internal departments and patient communications. And believe it or not, they correlate more than you think. This session explores how internal misalignment in communication can spill over into patient-facing interactions, impacting trust and clarity (and ultimately recruitment & retention). Using personality test frameworks like DISC, MBTI, and others, we’ll explore our own communication preferences, categorize communication styles of others, and how to adjust your approach to build stronger connections. When applied to patient recruitment, strong communication builds greater trust with patients by showing an understanding of who they are, their priorities, and how they communicate. When patients feel understood, you earn their trust. When communication flows, recruitment follows.
Speaker: Addison Gumbert, Clinical Research Marketing Strategist, Premier Clinical Marketing
Clinical studies rely on seamless collaboration between sponsors, contract research organizations (CROs), and site teams. However, misalignment, communication breakdowns, and unclear expectations can slow progress and lead to frustration across all teams. This session will explore how to strengthen these essential relationships to accelerate study timelines, improve data quality, and reduce burnout. Drawing on real-world case studies and audience input, we’ll examine the most common pitfalls in sponsor-CRO-site dynamics and offer practical strategies to drive collaboration and trust. Speakers: Anna Rillo, BSN, RN, Associate Study Director, Bright Research; Claire Swan, Clinical Research Associate, Bright Research
This interactive presentation guides participants through applying proven project management principles across all scales of work, from organizational initiatives to everyday task management. Attendees will learn to leverage essential project management tools including strategic planning frameworks, effective scheduling techniques, Gantt chart creation and interpretation, and dependency mapping to optimize workflow and productivity. Through practical examples and hands-on exercises, participants will discover how to break down complex projects into manageable components, identify critical path dependencies, and create realistic timelines that account for resource constraints and competing priorities. The session will demonstrate how the same methodologies that drive successful large-scale initiatives can transform daily task management, reducing stress and increasing efficiency. Speaker: Leslie Pimentel Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital
The relationship between clinical research coordinators and monitors is at the heart of every trial. Too often, it is defined by miscommunication, mistrust, and turf wars, but clinical trials move too quickly and are too important to allow these avoidable barriers to persist. This interactive session, led by monitors who were once coordinators, flips the script. With a unique dual perspective of site and sponsor, the speakers explore how empathy, communication, and perspective-taking can transform this critical relationship from adversarial to collaborative. Attendees will gain heightened self-awareness and actionable strategies for their unique situations. When coordinators and monitors work in sync, clinical trials run smoothly. Let’s rethink the status quo and co-create a culture of mutual respect and shared goals–because better relationships mean better research. Speakers: Jodie Addington, Senior Specialist, Clinical Research Monitoring, Edwards Lifesciences; Kelly Chan, BS, CCRA, Manager, Clinical Research Monitoring, Edwards Lifesciences; Misty Daniel, CCRC, CCRA, Senior Specialist, Clinical Research Monitoring, Edwards Lifesciences
Research sites often juggle multiple sponsor-required technology systems across their studies. This patchwork of systems can lead to duplicative data entry, repeated training, and inefficient workflows that add significant administrative burden to already demanding workloads. This session will introduce a new AI-powered ChatGPT-like experience for protocol and study document review, and how using site-preferred systems—including the electronic medical record (EMR) and clinical trial management system (CTMS)—can help researchers and coordinators work more efficiently in sponsor-led trials. We will discuss workflows that integrate with existing systems and explore how greater flexibility in technology choices can reduce duplicate work and streamline daily study tasks. Attendees will gain a practical understanding of how Bring Your Own Technology BYOT approaches are evolving across the clinical research ecosystem and how leveraging familiar systems can simplify study operations. Sponsored by Advarra. This session does not provide ACRP Contact Hours. Speaker: Keith Wright, VP, Solutions Consulting, Advarra
This session is designed for new project managers and those aspiring to move into a project management role. The focus is on the project manager’s role in feasibility planning, recruitment execution, and effective communication. While job titles and responsibilities may vary across sponsors and contract research organizations, this session underscores the core project management practices that support the primary goal of delivering clean, reliable data and protecting study participants—all while keeping the study’s timeline on track. Speakers: Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health; Mary Lord, RN, MS, CCRA, CRA Manager, Site Management and Monitoring, Merck
This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings. Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidance, International Council for Harmonization guidelines, and ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for all stakeholders across the entire clinical research enterprise. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Clinical Research Compliance & Integrity, HCA Healthcare
U.S. Food and Drug Administration (FDA) inspections can be high-stakes events for clinical research sites, especially within large site networks. Yet, many sites and quality assurance (QA) teams only engage reactively, leading to inconsistent readiness and potential regulatory exposure. This session presents a proactive, collaborative model for ongoing alignment between site operations and the network’s QA function. Through real-world examples and practical tools, we’ll demonstrate how early QA involvement, open communication, and joint preparation foster a culture of continuous inspection readiness. Attendees will leave equipped with actionable strategies for collaborative mock audits, risk-based Corrective and Preventive Action (CAPA) plan implementation, and quality-focused training that empowers staff and mitigates FDA risk. Speakers: Margaret (Meg) Rood, VP, Operational Excellence, IMA Clinical Research; Andreja Vlajankov-Salaj, Sr. Director, Quality Assurance, IMA Clinical Research
The session is designed to open the door to a live reenactment of an institutional review board (IRB) meeting that includes samples of the most sensitive and controverted decisions facing IRBs today. The purpose is to inform researchers of the inner workings and, more importantly, the often intense deliberations arising from today’s clinical trial proposals and reports as the panel reconciles regulatory mandates and ethical principles with modern research conundrums. The 30-minute, mock IRB meeting will include a protocol, amendment, report of noncompliance, and continuing review followed by a 15-minute Q&A opportunity. Speakers: Claudia G. Christy, MSN, RN, CCRC, ACRP-CP, FACRP, IRB Board Member, Univo IRB; Melissa Gottke, BA, CIP, IRB Chairperson, Advarra; Amanda Higley, MS, PhD, CIP, IRB Chair Director, Advarra IRB; Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB; Deborah L. Rosenbaum, FACRP, CCRC, CCRA, ACRP-CP, ACRP-PM, Consultant, Sarrison Clinical Research, LLC
It is often straightforward to recognize FDA regulatory oversight when working on industry-sponsored studies conducted under Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. However, clinical research professionals frequently encounter uncertainty when determining whether FDA oversight applies in less obvious scenarios, including investigator-initiated, multisite, or early-phase studies. This session will present a practical framework to help participants identify and flag FDA regulatory oversight by walking through key indicators of IND/IDE applicability, common misconceptions, and critical decision points that influence regulatory classification and IRB review. The session will also explore emerging regulatory considerations related to artificial intelligence and machine learning–based products, companion diagnostics, radiation-emitting devices, and digital health technologies. Participants will leave with practical decision tools, case-based examples, and communication strategies to support confident, compliant conduct of FDA-regulated research. Speaker: Purna Garimella, MS, CIP, RAC, Director, Human Research Protection Program, Indiana University
This fast-paced, highly interactive lecture helps clinical research and quality professionals move beyond terminology and into real-life application. Participants will examine practical strategies and thinking to implement oversight, Quality by Design (QbD), and risk-based thinking in day-to-day trial decisions. Drawing on ICH E6(R3) expectations and real-world examples from both site and sponsor perspectives, the session includes guided activities and tools that help translate regulatory concepts into operational action. Attendees will also gain practical insight into two additional ICH E6(R3) expectations—data governance and fit-for-purpose thinking—showing how these concepts apply to system design, oversight, and proportional quality approaches. Interactive elements such as Buzzword Bingo, live polling, and decision-based scenarios reinforce key concepts and encourage critical thinking. This session is ideal for site and sponsor professionals seeking clarity, confidence, and practical insight into applying ICH E6(R3) in the real world. Speaker: Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Does working with your IRB feel like a roadblock? With the right strategies, you can develop a powerful partnership to ensure ethical, efficient, and compliant research. In this session, participants will learn how to communicate with the IRB in ways that reduce delays, improve protocol clarity, and support ethical decision-making. Grounded in real-world IRB review practices, federal regulations (45 CFR 46), and institutional experience, we’ll explore what the IRB actually prioritizes in a protocol submission and how to deliver a clear and concise submission for review. We’ll cover how to describe study activities in a way that aligns with regulatory criteria, write protocols with clarity around data handling, participant interactions, and multi-site coordination, and navigate pushback or differing IRB interpretations. Whether you’re managing a straightforward survey study or a complex, multi-site data integration project, this session will equip you with strategies to make your IRB submissions more efficient and effective. Speakers: Rachel Lally, MPH, CIP, Assistant Vice President for Research, Penn State University; Challace Pahlevan-Ibrekic, Director, Clinical Research, Northwell Health
In response to growing pressures from federal sponsors to demonstrate efficient research oversight, the Penn State College of Medicine undertook a strategic reorganization of clinical research monitoring and auditing services. This effort involved centralizing monitors from multiple units and realigning an auditor into our human research quality assurance office. A scalable chargeback model was developed to support this new structure, financial stewardship, and risk-based workload allocation. Attendees will learn how institutions can transition from siloed, grant-dependent quality functions to a centralized model that is both cost-recoverable and operationally sustainable. They will learn how to evaluate capacity, align oversight with risk profiles, and design a flexible fee structure based on study complexity and enrollment. The session explores how the reorganization positions the institution to adapt to the evolving expectations around indirect costs. This presentation provides a practical roadmap for modernizing research oversight by enhancing sustainability, or maximizing value from existing resources. Speaker: Kevin Gardner, Jr., MS, BSN, RN, CCRC, Director, Clinical Trials Office, Penn State College of Medicine
The question of how—and how much—to compensate research participants is far from settled. While undue influence remains a central concern, too little compensation can be equally problematic—failing to respect participants’ time, reinforcing inequities, and limiting recruitment from underrepresented groups. What truly constitutes “undue influence”? Should compensation only reflect time and inconvenience, or also acknowledge risk? Do higher payments undermine voluntariness, or do they simply acknowledge the realities of participation? This session will examine current debates alongside emerging trends, including reimbursement versus compensation, digital wallet payments, gamification, and punitive terms of payment. Drawing on ethical frameworks, regulatory guidance, and real-world case examples, we will provide attendees with practical tools to evaluate and justify compensation strategies that withstand scrutiny while supporting participant trust and engagement. Speaker: Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB
This session will discuss the implementation a novel tool for Identifying IRB Review Level for Studies involving Secondary Use of Data/Specimens. Speaker: Leslie Bell, Regulatory Specialist, Medical University of South Carolina-South Carolina Clinical and Translational Research Institute (SCTR)
This session explores a real-world case study from an interventional oncology trial to demonstrate how informed consent can be ethically and systematically optimized for vulnerable participants with impaired decision-making capacity. Attendees will examine how regulatory requirements and institutional safeguards can be integrated into a practical framework that ensures participant protection while supporting trial enrollment. Through a step-by-step analysis, we will cover patient eligibility verification, capacity assessment, legally authorized representatives, and documentation practices. The session offers a reproducible and proactive framework for how early planning, use of validated tools, and adherence to institutional review board guidance can support ethical trial conduct involving vulnerable populations. Speaker: Elena Alferova, Clinical Research Regulatory Coordinator II, UCSD Moores Cancer Center
This presentation will discuss the experience and process of building a quality assurance/quality improvement (QA/QI) program from the ground up following the merger of two large health systems across geographical distances. It will discuss where to begin, considerations when designing services, operationalization, the importance of including stakeholders, and lessons and pitfalls learned through real-world experiences. Speakers: Sarandeep Kaur, MS, CCRC, Research Accountability Specialist, Corewell Health; Karen Sherer, Director, Research QA/QI, Corewell Health; Laura Stuecher, RN, BSN, CCRP, QA/QI Research Specialist, Corewell Health
How does a site know that a sponsor’s medical device and study design will generate appropriate scientific evidence to justify or require a clinical trial? Sites may already be familiar with the sponsor and investigator responsibilities for Investigational Device Exemption (IDE) studies outlined in 21 CFR 812 of the Code of Federal Regulations, but this session will provide a tutorial on the regulatory expectations for IDE application submission or a non-significant risk (NSR) determination before initiating device clinical trials. The content will cover IDE applications and the documents that will be reviewed by the U.S. Food and Drug Administration before approving an IDE and how an NSR determination translates to abbreviated 21 CFR 812 requirements. Also discussed will be design controls to ensure a medical device is clinically ready for a clinical trial and how they still apply to NSR device studies including in vitro diagnostic products. Speaker: Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
As the ICH E6(R3) guideline reshapes expectations for Good Clinical Practice, organizations must go beyond compliance to embed risk-based thinking and critical-to-quality practices across functions. This panel brings together senior leaders to share firsthand experiences of putting the new guideline into practice—from big-picture strategy to everyday decision-making. Panelists will discuss how critical thinking supports better choices, where risk-based approaches add the most value, and lessons learned in leading the cultural mindset shift needed for sustainable quality practices. Attendees will walk away with practical strategies to lead change, collaborate across functions, and build systems that last. Speakers: Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health; Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy; Emma Pinto, BA, MBA, Manager, Clinical Trial Education & Communications, Kaiser Permanente Northern California Clinical Trials Program; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC; Jennifer Tugwell, MSN, RN, ACRP-CP, Sr. Manager Clinical Trials Education, Training & Policies, City of Hope
In 2025, the U.S. Department of Health and Human Services (HHS) initiated several significant policy changes impacting how clinical trials are conducted in the U.S. This session will explore five major developments: updated informed consent standards prioritizing plain language and accessibility; new HHS-led interoperability efforts to streamline trial data exchange; clarified Internal Revenue Service guidance on taxing participant stipends; a shift from mandated diversity action plans to a voluntary reporting framework; and cross-agency modernization efforts through the HHS Clinical Trials Modernization Working Group. These changes—while intended to promote transparency and innovation—have introduced ambiguity for sites, sponsors, and contract research organizations. Attendees will gain clarity on how to operationalize these updates, navigate compliance challenges, and align processes with the evolving federal landscape in 2026 and beyond. Speakers: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare; Sophia McLeod, Director, Government Relations, Association of Clinical Research Organizations (ACRO)
Artificial intelligence (AI) is transforming clinical research by streamlining patient identification, automating data capture, and enhancing imaging analysis. This session explores practical applications of AI in oncology trials, focusing on three high-impact areas: 1) patient matching and identification using advanced algorithms to accelerate enrollment and improve diversity; 2) seamless data collection through integration from electronic medical records to electronic data capture, reducing manual errors and increasing efficiency; and 3) automated imaging analysis, such as AI-driven RECIST measurements, to improve consistency and speed in response assessments. Attendees will take away actionable insights and learn from real-world examples for implementing AI solutions while addressing challenges in adoption, data quality, and regulatory considerations. Speaker: Chelsea Osterman, MD, Executive Medical Director, Tempus AI
Artificial intelligence (AI) is revolutionizing clinical research by enhancing protocol generation, operational efficiency, and participant recruitment/engagement. Through predictive analytics and digital twins, AI streamlines protocols, optimizes inclusion criteria, and minimizes risk. AI also strengthens safety monitoring by identifying early adverse event patterns across diverse datasets, enabling proactive responses. For sponsors and sites, AI supports ongoing access to training and streamlines standard operating procedure development by analyzing past performance and recommending standardized practices. It automates data collection, reducing manual errors and accelerating timelines. In recruitment, machine learning matches ideal candidates using electronic health records and real-world data, while adaptive algorithms personalize recruiting messaging to improve enrollment rates. Together, these innovations reshape the trial landscape, making studies faster, safer, and more inclusive without compromising data integrity or participant protection. Examples reviewed include seen and unseen real-world AI impacts. Speakers: Alain Alvarez Legra, Director for Clinical Research Coordinators, Bolanos Clinical Research; Karen Lindsley, DNP, MSN, RN, CCRC, CDCES, Manager of Regulatory Knowledge and Support, Clinical and Translational Science Alliance of Georgia, Emory University
Clean data don’t just fall from the sky. They are the result of smart systems, agile teamwork, and strong protocol design. We’ll walk through real-world cases involving National Institutes of Health-funded clinical trials launched during the pandemic and adapted for decentralized and hybrid delivery models. Attendees will learn how to navigate complex databases even when study teams lack experience with Good Clinical Practice, design usable workflows from complicated protocols, and handle unexpected data management hurdles. We’ll share wins, near-misses, and lessons learned from integrating mobile apps, multiple electronic data capture platforms, Veterans Affairs systems, and real-time secure file transfer protocols. We’ll tie it all together using coordination science principles to show how better communication, shared understanding, and team alignment can lead to cleaner data and fewer deviations. Come for the strategy, stay for the stories, and leave with tools to clean up your own data chaos. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Jamie Dwyer, MD, Assistant Vice President for Clinical Research, University of Utah; John VanBuren, PhD, Senior Faculty Biostatistician, University of Utah
Too few research organizations (e.g., sponsors and sites) have access to the large and diverse populations that primary care organizations (PCOs) and their healthcare professionals serve. This session will bring forth the results and easy-to-use, action-oriented tactics from the first-of-its-kind “Research in Primary Care Action Roundtable,” which included participants from PCOs, study sponsors, and study sites. PCOs are a healthcare entity focused on delivering first-contact, comprehensive, and continuous care to individuals and families across all ages, genders, and health conditions. They care for more than 100 million people in the United States, yet clinical trial access and participation through them continue to be seen at minimal levels. A shared vision is to build a movement to make clinical trials mainstream in support of healthcare’s pivot toward value-based care, and to provide research organizations with access to large and diverse populations leading to more efficient, representative, and accelerated study enrollment. Speakers: Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science, Genentech; Osa Eisele, MD, MPH, Executive Director and Head of Representation in Clinical Research, Amgen; Pete Fronte, MBA, President & CEO, Altura; Rakesh Patel, MD, MBA, FACHE, CPE, CEO, Neighborhood Healthcare
Minoritized populations have historically been underrepresented in clinical trials. Speakers for this panel from a research center located in an underserved California community that is 80% Latino have found that observational trials—when strategically implemented—can build trust and engagement. Panelists will share their experiences with an Alzheimer’s disease observational study that became a catalyst for broader community involvement. The site achieved top-three national enrollment, increased Latino participation, and fostered partnerships with local community centers and adult day programs. The effort significantly improved health literacy and facilitated acceptance of interventional Alzheimer’s trials. The center’s site director, manager, study coordinator, pre-screener/recruiter, and community engagement representatives will highlight key strategies across all stages of the trial, demonstrating how observational studies can enhance community engagement, reduce stigmas related to trial participation, and lay the foundation for future research. Speakers: Emilia Alcala, Clinical Research Coordinator, Sun Valley Research Center; Leslie Michelle Dowling, Site Manager, Sun Valley Research Center; Judy Galindo, CCRC, Executive Director & Site Co-Owner, Sun Valley Research Center; Vanessa Nuño, Community Engagement Representative, Sun Valley Research Center
As clinical research evolves, sites are challenged to streamline workflows while upholding rigorous regulatory standards. This presentation outlines an evidence-informed approach to modernizing research conduct through informatics and digital tools. The session will deliver actionable strategies for integrating computerized systems into clinical research infrastructure—including electronic source documentation, e-regulatory platforms, and billing compliance automation. The session will explore key performance indicators to assess site health, lessons learned from multisite consultations, and practical guidance for regulatory alignment across varied geographic regions. Emphasis will be placed on optimizing research operations in academic settings, promoting digital transformation, and fostering global collaboration. Attendees will gain tools to assess and enhance site-level research operations; implement informatics systems that support regulatory integrity; and align compliance strategies with evolving state and federal guidelines. This session is ideal for clinical research professionals, site directors, and compliance specialists seeking to advance digital integration and sustain high-functioning research programs. Speaker: Candida Barlow, PhD, MSN, CRN-BC, RN, Director Clinical Research, Oklahoma State University Center for Health Sciences
The emergence of decentralized clinical trials (DCTs) has reshaped the way we approach execution of clinical trials requiring few or no face-to-face touchpoints with patients. A successful DCT requires a different operational infrastructure, different technology, and different personnel from a traditional clinical trial. This session offers a practical, end-to-end toolbox for designing and operationalizing DCTs. Attendees will learn actionable strategies for protocol design that allow remote workflows and patient-centric recruitment. We will discuss common pain points that contribute to attrition in DCTs and strategies for prevention. The session will review approaches for building and leading remote teams and for leveraging technology to improve efficiency of remote work. Finally, we will discuss the role of the principal investigator, research coordinator, and data manager as they are deployed in a decentralized fashion. This talk is for those interested in launching DCTs and for those running DCTs who want to expand their capabilities. Speakers: Kimberly Lamberti, PhD, Senior Clinical and Regulatory Affairs Specialist II, Nilo Medical Consulting Group; Marianne Parrish, MPH, Clinical Project and Data Manager, Nilo Medical Consulting Group
Sponsors are revolutionizing the site experience by leveraging artificial intelligence (AI) to develop a survey automation tool, significantly simplifying the site feasibility survey process. This tool aims to reduce administrative burdens, enhance data accuracy, and provide real-time support, making it easier for sites to participate in clinical trials. Beyond current metrics, AI is also employed to identify the best-fit sites by creating an optimal potential site list based on extensive priorities. This includes tiering sites according to past performance, quality, and proximity to diverse catchment areas. By integrating these advanced AI-driven techniques, sponsors ensure that the site selection process is efficient, inclusive, and of the highest quality. These efforts not only streamline operations but also foster stronger collaborations with sites, ultimately advancing clinical research and improving patient outcomes. Speaker: Bonnie Lam, Feasibility, Strategy and Analytics Lead, Pfizer Inc.
Sites are overwhelmed by the increasing number and complexity of technology solutions required to execute clinical trials. This is exacerbated by the increasing number of solution providers selected. Currently, research sites are typically required to use sponsor-provided technology systems. The Decentralized Trials and Research Alliance’s (DTRA’s) “Bring Your Own Technology” initiative aims to enable clinical research sites to use their own validated technology systems in industry-sponsored clinical trials while maintaining regulatory compliance and sponsor oversight. The objective is to reduce operational inefficiencies, improve data quality, and enhance site and patient experiences. This session will share the work done by DTRA to date to define a process to enable adoption of site-preferred technology in registrational trials. Using eConsent as a model, key considerations and impact assessments conducted to identify opportunities and challenges from a multi-stakeholder perspective will be shared. The work continues in 2025-26, focusing on site-preferred eSource adoption by sponsors. Speakers: Joe Dustin, Founder and Principal, Dauntless eClinical Strategies; Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions
Artificial Intelligence (AI) is no longer a futuristic concept in clinical trials, it’s an emerging reality with real-world impact across design, recruitment, operations, and data analysis. This session presents insights from a multi-stakeholder working group exploring how AI is being applied in practice, what responsible use looks like, and what collective standards are needed to ensure adoption accelerates rather than fragments progress. Through interactive discussion and scenario-based exploration, participants will examine proposed practical frameworks for AI governance, definitions of responsible use, and baseline metrics for measuring AI’s effectiveness. The session will also outline regulatory engagement strategies and explore key global differences in AI oversight. Attendees will leave with tools to guide internal conversations, assess vendor claims, and contribute to shared industry alignment on AI in trials. Speakers: Andrea Bastek, Ph.D., VP of Market Strategy, Florence Healthcare; Victor Chen, Principal, The CK Clinical Group; Heather Manley, MS, LPC, Senior Site Director, JCCT
This session will provide key topics in keeping up with new monitoring techniques in the dynamic atmosphere of decentralized clinical trials. We will explore how to use modern systems and technology to aid in efficiency in monitoring both virtual decentralized clinical trial sites and brick and mortar sites participating in decentralized clinical trials. Topics examined will include a discussion of systems used in decentralized sites and decentralized trials, navigating these systems, and creating bespoke methods of monitoring to respond to novel models of clinical trials. Speaker: Jessica Carlson, BA, CCRA, Sr Clinical Research Associate, Apogee Therapeutics
The field of oncology clinical trials is dynamic and intricate, with continuous evolution introducing new challenges for research sites. This panel discussion features seasoned representatives from highly active research sites sharing their innovative strategies for navigating this evolving landscape. While universal solutions are elusive, each site employs a unique blend of technology and human expertise to achieve its research objectives. Speakers: Meghan Degele, Sr. Director, Tempus AI; Tiffany Kirkpatrick, PharmD, ACRP-CP, Cancer Research Quality Program Manager and Research Pharmacist, Avera Cancer Institute; Ashley Servais, Director of Clinical Research, Nebraska Cancer Specialists; Alexis Wilson, Research Clinical Operations Coordinator, MemorialCare
Technology rollouts in clinical research struggle when change isn’t managed effectively. This session explores how to lead successful transitions to site-based eClinical solutions like electronic investigator site files, electronic source, and participant engagement platforms. The session will highlight common pitfalls in site-level implementations and how to avoid them through proactive communication, pilot workflows, and leadership alignment. Designed for site leaders and operations professionals, the session focuses on practical, real-world strategies for overcoming resistance, fostering cross-functional buy-in, and building adoption plans that last beyond go-live. Attendees will walk away with a clear framework on how to engage stakeholders early, design training that sticks, and track meaningful adoption metrics. Speaker: Alicia Gearhart, Director of Professional Services, RealTime eClinical Solutions
This session will delve into the critical role of academic medicine in clinical research, exploring why it is considered the pinnacle of clinical trials. We will discuss the historical and current challenges faced by academic researchers and how they are navigating the modern clinical trials environment. The session will review the impact of startups, technology, data, patient engagement, and newer political challenges on medical research. We will also identify solutions for current bottlenecks in academic research and propose strategies for moving forward and thriving in the current environment. Attendees will gain valuable insights into the evolving landscape of clinical research and the innovative approaches being employed to overcome obstacles. The session will conclude with a Q&A segment, allowing for an interactive discussion with the audience. Speaker: Edwina McNeill-Simaan, EdD, MSHS, CCRC, CCRP, Program Director, Vanderbilt University Medical Center
Clinical trial recruitment faces persistent challenges, including prolonged enrollment periods, high screen failure rates, and inconsistent data quality. This session introduces the innovative block enrollment strategy, which accelerates trial recruitment by concentrating all site resources on a single protocol during a focused enrollment period. By aligning the entire research team and optimizing patient engagement, the block enrollment approach improves enrollment efficiency, reduces screen failures, and enhances participant retention. Drawing on real-world data from ophthalmic trials, attendees will explore how this model streamlines workflows while maintaining rigorous quality standards. The session will engage participants in discussing scalability and adaptation of block enrollment across various therapeutic areas. Key roles of principal investigators, study coordinators, and support staff in this focused recruitment method will be highlighted. Attendees will have the opportunity to learn about a transformative, practical approach that reshapes clinical trial enrollment and optimizes site performance. Speaker: David Almeida, MD, MBA, PhD, President and CEO, Centers for Advanced Surgical Exploration (CASEx) and Erie Retina Research
Clinical research is often seen as a risk-averse industry, but is that perception accurate? This interactive session challenges the assumption that traditional choices are inherently safe. Through real-world case studies and a behavioral risk framework, we’ll explore how decisions around protocol design, site selection, technology adoption, and feasibility often mask high operational risk under the guise of caution. Attendees will examine how “playing it safe” can lead to protocol amendments, recruitment failures, and delays, and learn how to use Quality by Design (QbD) and ICH E8(R1) principles to anticipate and mitigate these outcomes. The session includes audience polling, risk-mapping exercises, and practical tools to identify where organizations may be unintentionally risk-seeking. Whether you’re in study startup, clinical operations, or site management, you’ll walk away with actionable strategies to reframe risk, support better decision-making, and challenge the illusion of safety that drives costly inefficiencies in clinical trials.
Speakers: Mitchell Hilbe, CEO / Co-Founder, DiversiTrials; Jess Thompson, CEO, Clinical Research Pro; Jami Walker, Clinical Operations and Management, Mead Johnson
Manual data entry drains site resources and delays trial timelines, especially as studies grow in complexity, volume, and number of sources. However automated electronic health record-to-electronic data capture (EHR-to-EDC) integration can dramatically reduce site burden when it’s designed with usability in mind. This session explores what it really takes to make eSource and EHR-to-EDC work for sites: no new systems, no additional logins, no information technology support—just streamlined, intuitive workflows that fit naturally into how research coordinators already work, drawing on experiences from dozens of oncology trials across academic and commercial research settings. Attendees will gain actionable insights on how EHR-connected workflows can save time, reduce errors, and improve monitoring through traceable data capture, plus practical best practices for improving execution, supporting smarter source data verification, and scaling eSource without added complexity. Speakers: Samir Jain, VP, Product Management, Healthcare Data Interoperability and EHR Solutions, Medidata, Dassault Systemes; Milijana Ugrenovic-Petrovic, Senior Director, Clinical Trials Office, Moffitt Cancer Center
The advancement and rapid utilization of artificial intelligence (AI) scribes and other AI assistant tools in the clinical space raise new questions about what constitutes “source” for data in healthcare settings. During this discussion, we will look at AI scribe programs that are currently being used at major hospitals and clinics across the U.S. in order to identify concerns, discuss mitigations, and better understand what should be considered when conducting site qualification visits from a quality management perspective. For example, what is the source when the original records/transcripts are not maintained? What is the role of investigators in ensuring accurate, artificially created notes and care plans? Does the institution have plans in place to ensure data integrity in the age of AI-generated notes? Speaker: Michele La Badie, ACRP-CP, ACRP-MDP, ACRP-PM, Clinical Trial Manager, Shoulder Innovations
This session will delve into how sponsors develop effective recruitment strategies for clinical trials, emphasizing the practical impact of these tactics. Attendees will gain insights into how feedback from clinical sites is utilized by sponsors to craft creative and adaptive recruitment approaches. The session will highlight real-world examples and case studies to illustrate the success of these strategies in enhancing participant engagement and trial efficiency. Speakers: Simranjit Mehta, Recruitment Strategist, Pfizer; Nikki Thomas, Recruitment Strategist, Pfizer
This session will highlight the transformation of protocol activation and lifecycle management that results in improved research billing compliance, streamlined workflows, aligned financial policies, and enhanced training curriculum. Despite the complexity of study activation, we found that mastering the basics—clear policies and procedures along with practical tools—was key to success. Attendees will leave with strategies and tools to confidently support clinical trial workflow transformation projects. Speakers: Chad Eriksen, MS, CCRC, FACRP, President, Strategic Advisor / Sr. Project Manager – Yale Center for Clinical Investigation (YCCI) Iron Horse Research; Kayleen Joyce, MS, CCRC, ACRP-PM, Consulting Manager, Huron Consulting Group
Transform your workplace culture through proven strategies that build genuine employee engagement, trust, and accountability. This session focuses on creating a thriving organizational environment where employees feel valued, connected, and motivated to contribute their best work. Participants will learn to establish trust as the foundation of engagement through transparency and consistent leadership behaviors. The session features the innovative ALIGN method for collaborative goal setting, enabling teams to create shared objectives that drive organizational success. Discover how to shift from traditional performance reviews to growth-focused evaluation conversations that inspire development rather than judgment. Learn to implement positive accountability systems that support employees while building trust. Key topics include positive workplace habits, open communication channels, transparent progress tracking, and sustainable cultural change through continuous feedback and recognition. Attendees will leave with practical frameworks and actionable strategies to immediately transform their workplace culture. Speaker: Leslie Pimentel Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, University of New Mexico Hospital
Ready to take the next step in your clinical research career? Join this expert panel of ACRP Certified professionals—leaders who’ve served on the Academy Board, committees, as item writers, and more—to gain insider knowledge on achieving your certification. They’ll share their personal journeys and practical strategies for success, from navigating the application process to preparing for the exam. Discover what to expect during eligibility review, explore testing options, and learn proven study tips that can help you earn the most reputable credentials in the clinical research industry. ACRP Certification goes beyond the letters—learn how it can be a catalyst for impact, opportunity, and career growth. Please note that this session will not cover exam content. If you have questions regarding your individual certification journey, please talk to the staff at the ACRP booth in the Expo Hall. This session does not provide ACRP Contact Hours. Speakers: Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health; Tiffany Taylor Mayo, MD, Associate Professor of Dermatology; Director of Dermatology Clinical Research, The University of Alabama at Birmingham; Jen Milam CAE, ICE-CCP, Certification Manager, ACRP; Robert O’Connor, CCRA, ACRP-CP, FACRP, Senior Clinical Scientist, The Procter & Gamble Company
This session explores how to celebrate Gen Z colleagues, collaborate effectively with Millennial bosses, and embrace the strengths of a multigenerational workforce. Today’s organizations face new challenges as employees bring diverse values, attitudes, and expectations. Baby Boomers represent 15% of the workforce, Gen X 31%, Millennials 36%, and Gen Z 18%. Participants will learn to identify and compare generational core values and cultural influences to enhance communication and build high-performing, inclusive teams. The session highlights recognizing personal biases and avoiding snap judgments about other generations. A key focus is the paradigm shift from a traditional “boss” mentality to a “coach” approach, fostering trust and engagement across age groups. In the clinical research community, where collaboration is critical, each generation contributes unique strengths and perspectives. This session equips attendees to support intentional cross-generational communication, encourage mutual understanding, and leverage diversity to strengthen teamwork and improve outcomes in this dynamic environment. Speakers: Yekatrina Tsabur, Organizational Consultant, Sophos; Yelena Tsabur, Organizational Consultant, Sophos
Join us for an inside look at how the Center for Clinical Research Management (CCRM) transformed its onboarding approach to meet the evolving needs of today’s clinical research environment. This session explores the creation of a scalable, flexible, and role-specific training program that balances standardization with individualization. Discover how platforms like Microsoft Teams, REDCap, and OnCore CTMS were integrated to enhance training, compliance, and collaboration. We’ll share key lessons, data insights, and practical tips to help you build or refine your own onboarding systems. Speakers: Amber Anaya, MS, CCRP, Clinical Research Manager, The Ohio State University; Kelly Dunsky, MS, CCRC, Associate Director of Clinical Research Operations, The Ohio State University
Whether you’re early in your career or a seasoned professional, it’s easy to confuse “doing good work” with “communicating your value.” This session offers practical tools to help you tell your professional story with clarity and purpose—on paper, online, or in conversation. Through guided reflection, real-world examples, and structured templates, you will learn to draft an authentic elevator pitch, apply the STAR (Situation, Task, Action, Result) method to describe outcomes, translate daily work into impactful résumé or LinkedIn content, and outline a focused 30-day communication plan with practical actions to build visibility and confidence. Beyond the job-seeking context, the focus is on ongoing visibility and confidence—whether you are looking to grow, pivot, or lead from where you are. Advancement isn’t just about upward mobility—it’s about alignment with your goals. This session delivers usable tools to help you own your narrative and support career development in any direction. Speakers: Alissa Mun, Health Scientist Policy Analyst, U.S. Food & Drug Administration; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
To engage the future clinical research workforce earlier, our team created a collaborative summer camp for high school students. This session explores the facilitators and barriers to designing and implementing a curriculum across multiple academic institutions. Attendees will learn strategies to address challenges such as inter-institutional coordination, resource allocation, and maintaining consistent quality and engagement. We will share insights on effectively reaching high school students and fostering their interest in clinical research. Key findings include identifying success factors and obstacles in multi-institutional collaboration, applying a team science framework, and integrating Bandura’s Four Elements of Social Learning Theory into lesson planning. We will also present our evaluation methods, including pre- and post-tests, self-efficacy measures, and participant feedback. Finally, we will introduce a comprehensive toolkit for replicating the camp model, featuring lesson plans, evaluation tools, and best practices. Speaker: Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor & Director, Master of Clinical Research and Certificate Programs, The Ohio State University
A site’s greatest asset isn’t its technology—it’s its people. As clinical trials grow in complexity, building confident, capable teams is essential for quality execution and staff retention. This session introduces a practical, mentorship-based approach to empower site staff at all levels, drawn from real-world experience leading clinical teams through change and growth. Attendees will learn how structured onboarding, peer mentorship, and ongoing development improve protocol compliance, morale, and team stability. Whether you’re training new coordinators, addressing burnout, or fostering internal leadership, this session offers actionable tools to strengthen site performance by investing in your people. Speaker: Dean Jang, Site Director, IMA Clinical Research
Training challenges persist throughout the clinical research enterprise. This session presents benchmark data and discusses practical solutions for partnerships between sponsors, contract research organizations, and sites to address site-based training shortcomings for the betterment of clinical trial conduct. Speaker: Jimmy Bechtel, Vice President, Site Engagement, SCRS
The Careers in Clinical Research (C-CLEAR) Program is an eight-week immersive summer experience designed to introduce undergraduate students to careers in oncology clinical trials. Hosted by the University of Kansas Cancer Center’s Clinical Trials Office, the program provides hands-on exposure to core research functions including informed consent, protocol navigation, adverse event reporting, regulatory documentation, and data entry. Students complete Good Clinical Practice (GCP) training and gain real-world experience through shadowing across multiple departments, including time with oncologists in the Phase One Clinic. The program also emphasizes professional development through mentorship, résumé building, and final presentations to research staff. This session will present a practical and replicable model for building early-career pathways into clinical research. Attendees will receive tools, strategies, and lessons learned to support workforce training and sustainable pipeline development in academic research settings. Speaker: Joseph Hines II, MPH, Executive Director, Research Operations-Clinical Trial Office, University of Kansas Cancer Center
Clinical expertise has a clearly defined role and purpose in clinical research from randomizing treatments to managing adverse events to monitoring the overall health of participants. However, scientific expertise seems to be expected only from those who design studies, analyze final datasets, and manage the investigational products in question. This increases a sense of separation between sponsors and sites that results in clinical trial operations being considered mostly in terms of financial transactions. At the site level, a similar divide in research staff often occurs as the study coordinators understand the study mechanics and the medical clinicians understand the disease, often causing friction in operations and staff turnover. By developing a novel clinical research model, our team has addressed these gaps and witnessed improvements in staff recruitment and retention as well as decreases in detrimental protocol deviations. This model includes a clear career development pathway for clinical research professionals. Speaker: Lacey Andrews, MS, CCRC, CCRA, Lead Coordinator, Marshall University’s Joan C. Edwards School of Medicine, Department of Family and Community Health; Todd Davies, PhD, Associate Director of Research, Marshall Health
Turnover among clinical research professionals increases trial costs, delays timelines, and compromises data quality. Across sponsors, contract research organizations, health systems, and academic sites, workforce instability puts studies—and outcomes—at risk. This session shares a case study from the healthcare sector, where investing in psychological safety through expert-led group coaching led to a 20-point drop in annual turnover and $32 million in annual savings—while improving team performance and engagement. Psychological safety—the belief that team members can speak up and take risks without fear—is a proven driver of retention, operational efficiency, and proactive problem-solving. Group coaching embeds this mindset into team culture, enabling trust, reducing errors, and supporting sustainable performance. Attendees will leave with practical strategies to apply this low-lift, high-impact approach to onboarding, leadership development, and daily operations. Speakers: Francie Jain, Founder & CEO, Terawatt, Inc; Tommy Thomas, CEO, Opposite Strengths Licensing, LLC
As clinical research embraces digital transformation, traditional roles in data management and adjacent functions are rapidly evolving. The integration of artificial intelligence, automation, and advanced analytics is reshaping how we collect, clean, and interpret data, impacting not only data managers but also medical monitors, safety reviewers, and clinical monitors. This session will explore practical strategies for upskilling and reskilling existing talent to meet the demands of tomorrow’s trials. Attendees will gain insights into identifying skill gaps, fostering a learning culture, and aligning workforce development with emerging technologies. We’ll also discuss cross-functional implications and opportunities for collaboration as clinical operations and data oversight become increasingly interconnected. Whether you’re leading teams or navigating change yourself, this session will provide a roadmap for talent transformation that keeps people at the center of innovation. Speaker: Tracy Parker, VP, Managing Director, IQVIA
Discover how prioritizing soft or aligned skills in hiring and training entry-level clinical research professionals can open sustainable pathways to success—and learn how to put skills-based hiring into action at your institution. We’ll briefly examine industry trends and the importance of a sustainable talent pipeline with the right skills. We will share our real-life experiences building a workforce development program, and provide tools for screening, hiring, and developing the desired soft skills. Participants will reflect on their own institutional needs and practices, and come away with actionable strategies to create inclusive, skills-based paths into the profession. By revisiting the Joint Task Force for Clinical Trial Competency model through the lens of your institution’s prioritized soft skills, you’ll assess alignment, identify gaps, and explore ways to refine expectations—ensuring your training goals and performance benchmarks are appropriate and personalized. Speaker: Kathleen OMalley, BSN, CCRP, Director of Education and Training, Jefferson Clinical Research Institute, Jefferson
Clinical research coordinators (CRCs) are the backbone of trial execution, yet many sites lack a structured, competency-based approach to support their development beyond onboarding. This session introduces a tiered CRC Competency Checklist designed to guide coordinators from beginner through advanced levels of practice. Originally developed for an independent research site, the checklist integrates the Joint Task Force Core Competency Framework and ACRP’s CRC Competency Development and Assessment Roadmap with practical, observable skill demonstrations—promoting role clarity, professional growth, and high-quality performance. Attendees will explore how this adaptable tool fosters ongoing workforce training, simplifies evaluations, and builds a culture of excellence. This session is designed for mid-level professionals seeking to improve training programs and enhance team performance. This session aligns with ACRP’s Workforce Development and Training focus by offering a sustainable method to invest in the growth and retention of CRCs across the industry. Speakers: Jesse Fuhriman, Clinical Research Coordinator, Rocky Mountain Clinical Research; Brittani Holden, Certified Senior Clinical Research Coordinator, Rocky Mountain Clinical Research; Kelsie Wetzel, Certified Senior Clinical Research Coordinator, Rocky Mountain Clinical Research
In a rapidly evolving clinical research landscape, effective leadership is more crucial than ever for driving collaboration, innovation, and trust among academic centers, site management organizations, and technology partners. This dynamic session will introduce the “Four Cs” leadership framework—character, competence, caring, and communication—adapted for today’s complex research environment. Three seasoned leaders with varied backgrounds will share insights on how leadership philosophies must adapt to varying organizational cultures, regulatory demands, and operational realities. Attendees will explore practical strategies to cultivate leadership capacity, manage resource constraints, and prevent burnout while promoting ethical and patient-centered research. Real-world stories will illuminate challenges and solutions in building and sustaining successful collaborations among sites, sponsors, contract research organizations, and academia. The session encourages interactive discussion, equipping attendees with actionable tools to strengthen their own leadership impact and foster high-performing, resilient research partnerships. Speakers: Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President, Clinical Research, Northwell Health; Elisa Cascade, MBA, FACRP, Chief Growth Officer, Head of Americas, TrialScreen; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
The clinical research workforce is facing growing challenges, especially in the recruitment and retention of research nurse coordinators. This session will highlight an innovative collaboration between a clinical research team and a bachelor of science in nursing program aimed at introducing nursing students to clinical research as a meaningful and dynamic career option. By engaging future nurses early in their education, this partnership helps bridge the gap between clinical care and research, building awareness, interest, and preparedness among new graduates. Attendees will hear how this model not only expands the pipeline of qualified professionals but also enhances the visibility and value of the research nurse coordinator role within healthcare. The presenters will share insights, lessons learned, and steps for developing similar collaborations with nursing schools. This forward-thinking approach has the potential to significantly strengthen the clinical research workforce and ensure a more sustainable, informed, and engaged generation of research-ready nurses. Speakers: Lauren Hasty, Clinical Research Nurse, St Jude Children’s Research Hospital; Jamie Russell, Manager- Clinical Research Management, St Jude Children’s Research Hospital
Training is an integral piece of the onboarding process for new staff in clinical research, but is often not approached systematically with evidence-based methodology. This session offers a framework for building efficacious and engaging orientation and training programs that emphasize problem-solving and critical thinking. Attendees will gain skills in identifying common areas of improvement in their own institution’s programs and learn how to apply teaching theories and skills to improve their curriculum and align with Joint Task Force competencies. The presentation will culminate in reviewing methods of data collection to assess the impact of changes made to a training program. Speaker: Aja Macias, Clinical Research Educator, Stanford Cancer Institute
The clinical research industry offers a variety of career pathways, yet many site-based professionals struggle to transition to roles within contract research organizations or sponsor settings. This session will outline the skills, experiences, and strategic positioning needed to make that leap successfully. Drawing from real-world examples, panel insights, and current hiring trends, we’ll explore how site-based coordinators, managers, and research staff can translate their operational expertise into qualifications for project management, clinical research associate, medical affairs, regulatory affairs, and other sponsor-side roles. Attendees will leave with a roadmap, tools for self-assessment, and strategies to proactively align their current responsibilities with future goals. Speakers: Tamika Harris, Clinical Operations Manager – Regulatory, Merck; Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, Merck