This package is a replay of 25 on-demand session recordings and presentation slides from the Study & Site Management Track at the ACRP 2026 Conference, April 24 – 27, Orlando, Florida. Offers clinical study site teams the insights and best practices needed to improve clinical trial execution and monitoring.
Member: $99 | Nonmember: $149
Participants can earn up to 21 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Learning Portal.
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