This package is a replay of 28 on-demand session recordings and presentation slides from the Study & Site Management Journey at the ACRP 2025 Conference, April 24 – 27, New Orleans, Louisiana. Learn practical, proven ways to maximize study and site performance.
Member: $99 | Nonmember: $149
Participants can earn up to 24 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 23, 2028.
Understanding that site management organizations (SMOs) are essentially the bridge between the sponsor/contract research organization (CRO) and sites, we will demonstrate proven quality improvement practices used by SMOs to reduce start-up timelines. Roles discussed involve study activation, regulatory compliance, contracting and budgeting, clinical education, and clinical trial management system oversight. Participants will understand the function of each role and how the delineation of responsibilities improves site compliance, data quality, and sponsor/CRO satisfaction with a site’s clinical trials. We will explore best practices using specific examples from real-world experiences, including technology use and templates covering communication, trial management, study and site specifics, etc. Speakers: Charita Braker, Manager, Clinical Research Education, HCA Healthcare Research Institute; Jessi Klindedinst, Manager, Regulatory Affairs, HCA Healthcare Research Institute
You can learn about the many facets of clinical research and have fun at the same time in this fast-paced game show format. Watch teams pit their knowledge of clinical research against each other until a winner emerges. Audience members will be encouraged to play along as their colleagues are challenged with questions that vary in complexity and subject. Questions may require teams to recall core principles of ICH Good Clinical Practice, eClinical technology, or the basics of informed consent, as examples. Speakers: Elisa Cascade, MBA, Chief Product Officer , Advarra; Vanessa Hill, Director, Research Compliance, Advarra Consulting – Institutional Research; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
Advancements in precision oncology have led to the development of life-changing, novel treatment modalities in the clinical trial setting. However, significant disparities persist in who benefits from these treatments. Public health has established core principles to ensure equitable access to care for all. How can the clinical trial landscape benefit by applying these public health principles to ensure equitable access to clinical trials? This session will explore the role of social determinants of health and provide a foundational framework for integrating community-based participatory research (CBPR) into current research projects. Participants will learn strategies to improve patient engagement and outcomes through CBPR. Attendees will leave with practical examples and methods to measure the success of their health equity initiatives in clinical research. Speaker: Rochelle Williams-Belizaire
This session explores the current state of available clinical research workload tools and compares several similar adaptations of a specific tool for tracking productivity at various types of research programs. The focal model presented offers great flexibility in both oncology and non-oncology settings, as it allows for continuity of care amongst study coordinators for their study participants. The metrics presented can be used to justify new and existing employees for research programs running clinical trials predominately on the high end of the acuity continuum. Further, the metrics can be used to increase funding for additional coordinator and support staffing while improving study coordinator job satisfaction and retention at sites. This allows sites to achieve their enrollment goals and promote progress in their clinical research practice. In the wake of such improvements, research programs can expect more funding opportunities and greater success. Speaker: Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
Community outreach remains the industry standard for patient recruitment in minoritized (and majority) communities. Defined as one-way communication, community outreach is often a transactional process that doesn’t typically leave room for bridging the gap between opportunity and community. While outreach may be necessary in some cases, we must begin to make a conscious shift toward engagement through true community partnerships for more equitable access and outcomes. This session is for those hoping to dive deep into community engagement planning and implementation for their organization. Attendees will come away with a new understanding of the pivotal role our communities play in shaping a more equitable and inclusive clinical trial landscape, and tools for deploying impactful and sustainable community engagement plans. Speaker: Ashley Moultrie, CCRP, Associate Director, Clinical Trial Diversity, Syneos Health
Whether you’re new to negotiating budgets or have been doing it for years, budgets can be daunting—each budget is different, challenging, and full of ever-changing details. What shouldn’t change is how you handle budgets from one time to the next, so it’s time to standardize your budget review process. During this session, you’ll learn how to determine costs at your site and then maintain, track, and update those costs while implementing a plan to use what you’ve developed. We’ll also discuss how to review a protocol to uncover hidden costs that can then be factored into your budgets. Speaker: Matt Lowery, ACRP-CP, CCRC, CEO / Principal Consultant, The Pathways Grp, LLC
Patient recruitment remains a significant challenge in our industry, often exacerbated by outdated U.S. Food and Drug Administration guidelines. Despite these constraints, there are ways to improve recruitment through better advertising practices. This panel brings together perspectives from sponsors/contract research organizations (CROs), institutional review boards (IRBs), and sites to discuss best practices within their organizations and how to form effective, mutually beneficial partnerships. We will focus on how sites and sponsors/CROs can implement winning strategies in patient recruitment advertising that also meet IRB review expectations. Each organization will offer actionable insights aimed at enhancing their processes to improve recruitment outcomes. Speakers: Meghan Joseph, Site Engagement, Patient Recruitment & Retention, Moderna; Matthew Maxwell, Chief Growth Officer, Centricity Research; Jason Rush, BS, CIP, Senior Director, Regulatory, Advarra; Christine Senn, PhD, CCRC, CPI, FACRP, SVP, Site-Sponsor Innovation, Advarra
With an educational sponsorship from Roche/Genentech, a team of collaborators from Genentech, the Association of Cancer Care Centers (ACCC), and ACRP united to study the impact of clinical research training at ACCC community cancer programs. Join the program leaders as they discuss the results of the impact of providing foundational and therapeutic area-specific clinical research training (oncology) at select ACCC community cancer programs to create a blueprint for training research-naïve oncology staff in the community setting. Included in the discussion are the results of a participant survey that report that learners believed the program improved their knowledge and confidence. Speakers: Ruma Bhagat, MD, MPH, Senior Director, Health Equity & Population Science (HE&PS), Product Development, Genentech, Inc.; Kimberly Demirhan, MBA, BSN, RN, Assistant Director, Education Programs, ACCC; Mona Gilliam MSN, APRN-BC, CNS, Director Medical Strategy: Congress, Alliances, Societies, Genentech; Kemi Oladipupo, Touro Cancer Center; Marian Valia, Head of Learning & Development, ACRP This session does NOT offer ACRP Contact Hours.
Numerous clinical trial failures are traced by the U.S. Food and Drug Administration back to inadequate oversight by principal investigators (PIs). This session delves into real-world examples of such failures, highlighting the threats posed to participant safety and trial integrity. We will explore key focus areas, including the qualifications of delegated individuals, adequacy of training, requirements for continuous supervision, and provisions for third-party oversight. Attendees will learn how to avoid common pitfalls and enhance PIs’ knowledge to ensure trial success. Additionally, we will discuss the practical application of risk-based quality management, the ongoing debate on the necessity of monitoring, and the impact of training deficits. This session is essential for clinical research professionals aiming to support PIs and uphold the integrity of clinical trials. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah; Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Owner, Independent Consultant, Responsibility Research; Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC, Independent Clinical Research Professional, Medical Writer, Consultant
We are experiencing serious shortfalls in the number of clinical research physicians (principal investigators) needed to keep the enterprise healthy, in part due to aging populations and to the aftereffects of restrictions and burnout from pandemic conditions. It is estimated that less than 5% of U.S. physicians are participating in clinical research at any given time. Is there a sustainable path to attracting and retaining new and returning physicians for conducting clinical studies? With approximately 70,000 clinical studies ongoing or planned, and 35% being U.S.-only, the challenge is to create a collective approach addressing the gap ahead. Sponsors, contract research organizations, site networks, and medical associations realized during the worst days of COVID-19 that collective minds create solutions. Engaging/involving more “research naïve” physicians is a key to success for stakeholders everywhere. Understanding what these physicians need is important. This panel will include physicians who are new to the principal investigator role. Why did they add clinical research to their patient-care services? What have they learned? Why have they continued in clinical research? Are their communities showing greater interest? What are their enrolled patients sharing with them about their experiences as participants? Speakers: Edwin Burkett, MD, Chief Medical Officer, Alliance Medical Ministry; Amir Herman, DO, Medical Director, East Northport Medical Care; Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc
In this session, an expert panel with members representing a top 10 industry sponsor; a research and policy center; an independent nonprofit organization; and a pharmaceutical business intelligence provider will share actionable insights on expanding the scope of diversity in clinical trials. The panelists will elaborate on the section of the new U.S. Food and Drug Administration (FDA) diversity plan guidance stating that “FDA advises sponsors to seek diversity in clinical trial enrollment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics. Speakers: Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Behtash Bahador (he/him), Director of Health Literacy, Center For Info & Study on Clinical Research Participation (CISCRP); Fenwick Eckhardt, Head of Diversity Strategy, Citeline; Meghan McKenzie, MA, Director of Health Equity and Clinical Research, Genentech’s Chief Diversity Office
An estimated 20% to 50% of trial protocols launched at sites will eventually close without a single enrolled participant, wasting considerable resources along the way. While not mandated, feasibility reviews are being utilized by many organizations to minimize the risk of opening studies that ultimately will fail. Stage-gate process, a framework described in industrial organization management, can help identify projects early that are likely not to succeed and stop them before extensive resources are invested, freeing those resources to support other projects more likely to succeed. The feasibility process should include review of a diverse array of resources–financial, human, and physical–as well as the ability to accrue needed participants. This presentation will discuss the stage-gate framework, provide tips on processes that can be used to implement a feasibility process, and offer metrics and data organizations can use to drive the analysis empirically. Speaker: Wendy Tate, PhD, MS, Product Strategy Senior Director, Advarra
In the world of research and development, we often think about new and emerging technologies, cutting-edge ideas, and innovative approaches. What if we could also strengthen the foundations by developing core competencies? The goal of this presentation is to highlight the importance of establishing and maintaining a healthy relationship between sponsors and research sites. This relationship highly relies on the competencies of the clinical research associate (CRA) to create and nurture this connection whatever the situation is (database lock, recurring issues/deviations, late sponsor payments, etc.). The presentation will focus on key strategies for maintaining effective communication and addressing common challenges. By promoting mutual respect and understanding, the CRA can ensure that both sponsors and sites work harmoniously toward common objectives. Emphasis will be placed on practical tips and real-world examples, exploring the Dos and Don’ts, important soft skills, and management of difficult conversations–ultimately aiming to enhance the effectiveness of clinical trials through strong and cooperative relationships. Speakers: Amine Sehboub, BSc, PgD, Pharm, Clinical Research Associate, Syneos Health; Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
How can sites decrease the most common non-compliance issues cited in regulatory inspections? The types and frequency of these findings have not changed significantly in the past decade. With increasing complexity in research protocols, quality remains a concern to regulatory authorities. While monitors play a significant role in ensuring site performance and compliance, U.S. Food and Drug Administration notices place the onus on site personnel. In this presentation, we will highlight areas of deficiencies seen over many years at investigator sites. We will also discuss common inspection findings and how to spot the pitfalls that sites need to address in order to ensure compliance in conduct, performance, and overall execution of clinical trials. Speakers: Suheila Abdul-Karrim, CCRA, FACRP, ACRP-MDP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant; Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC, Independent Clinical Research Professional, Medical Writer, Consultant
In clinical research, the deaf community continues to be a chronically underserved group. Ensuring accessibility for deaf patients can be a challenge without proper guidance. There are many paths to accessibility, including written communication, computer-assisted real-time transcription, use of interpreters, and providers who know American Sign Language, to name a few. This session will focus on strategies to improve accessibility for deaf patients at study sites. Attendees will learn how to choose the right communication method for their patients, interact with interpreters, and incorporate these expenses into the clinical trial budget. This session will challenge attendees to further their understanding of the deaf community and promote advocacy at their sites. Speakers: Krista Kachnik, BS, Clinical Research Coordinator, The Spine Network; Marcus Stone, PhD, ACRP-CP, Principal, The Spine Network
The future is here, and new technology available for investigational product (IP) management opens up a wide range of opportunities. In this session, we will provide an introduction to new IP temperature monitoring capabilities, cold chain innovation, digital automation, predictive analytics, and sustainable technologies that have the potential to enable enhanced quality and improve efficiency. We will also look at how new technologies at both the site and sponsor levels may support patient access to clinical trials and improve compliance with the tenets of ICH Good Clinical Practice. Speakers: Liza Hill, BS, ACRP-CP, ACRP-PM, Associate Director, Clinical Operations – Clinical Research Manager, Infectious Disease (US), Merck; Mary Williams, Associate Director, Clinical Operations, Merck
Payment for services in the healthcare industry is handled unlike the payment process for any other business. Learn the different models by which investigators can be compensated; the basics of the Anti-Kickback Statute, the False Claims Act, and the Stark Law; how they govern investigator payment; and the average per-patient investigator compensation by trial type. The speaker will share one hospital’s experience with successfully compensating physicians based on the various types of medical groups and hospital physicians they contract with. In this session, attendees can be prepared to learn about managing investigator payments; creating compensation that is fair, motivational, affordable, practical, legal, and agreeable; and motivating investigators without incentivizing them to perform clinical trials. Speaker: Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
The landscape of clinical trial design, conduct, and regulation continues to shift thanks to the rapid infusion of technology and an increased emphasis on inclusion and access. As a result, the U.S. Food and Drug Administration (FDA) and Congress are reevaluating their stances in a number of areas in order to further speed the path to healthcare innovation. However, these changes in policy can present operational challenges for sites and sponsors in the day-to-day management of trials and patient care. This session will run through the latest guidance changes and what they mean for sites and sponsors in 2025. Areas of focus will be the updated guidance on informed consent, diversity action plans, digital health technologies, decentralized clinical trials and Form FDA 1572 reform, use of real-world evidence, and changes to the FDA’s Bioresearch Monitoring Program inspection processes. Additionally, the speakers will address the final ruling on taxing patient stipends, the Inflation Reduction Act, and the Food and Drug Omnibus Reform Act of 2022’s mandate for innovation. Speakers: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare; Sophia McLeod, Advocacy Advisor, Association of Clinical Research Organizations (ACRO)
This interactive session is intended for experienced professionals who deal with complex clinical trials issues focused on during U.S. Food and Drug Administration (FDA) audits and inspections, need to understand the latest developments, and can contribute their own experiences. Presenters will cover important Good Clinical Practice topics to prepare for audits and regulatory inspections and for addressing any resulting observations. The presentation will be followed with hands-on activities to create corrective and preventive action (CAPA) plans, utilizing root cause analysis procedures to address FDA citations in Warning Letters, Notices of Initiation of Disqualification Proceedings and Opportunity to Explain, and Form 483s (Notice of Inspectional Observations). Tools will be provided and participants will work in groups. The session provides an opportunity to collaboratively hone skills in problem solving and root cause analysis, resulting in effective CAPA plans. Speakers: Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, Independent Consultant, Assured of Quality Consulting & Training; Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer
Site-centric recruitment models powered by data and innovation are proving to be successful when two criteria are met–they reduce the burden on the site and they reach the patient closer to home. From “just-in-time” practices to decentralized clinical trials, this session will explore different recruitment models from the perspectives of experts who have successfully managed these approaches–both from the site and sponsor sides. Attendees will walk away with details and examples that they can apply to their efforts in clinical trial recruitment. Speakers: Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus AI; Karla Polk, Clinical Research Executive
Maintaining optimal staffing levels to meet the dynamic nature of the clinical research environment effectively and efficiently has significant operational, financial, and compliance implications. Managing appropriate staffing levels across centralized offices requires communication, access to data, defined metrics, and an understanding of institutional processes. There are multiple mechanisms, tools, and resources to determine appropriate staffing levels for business roles to manage your clinical research portfolio. During this panel discussion, we will address various institutional methodologies for calculating full-time equivalent (FTE) needs and the data required to make informed decisions. This will help attendees identify opportunities for improving their infrastructure by exploring optimum staffing levels by task/function to promote quality research, meet sponsor expectations, and enhance workplace satisfaction levels in every role. We will also explore approaches to plan for growth and project future FTE needs. Speakers: Mindy Muenich, Senior Director, Huron Consulting Group; Shannen Nelson, Executive Director, Clinical Research Operations, Children’s Hospital Los Angeles; Stephanie Pabst, Assistant Vice President, Sponsored Research Services, Cincinnati Children’s Hospital Medical Center
This session will help attendees learn how project management techniques can streamline the clinical study start-up process. Discover essential skills like time management, risk assessment, and effective communication, and explore practical tools for strengthening them. Through interactive activities, attendees will be able to develop a robust project plan, manage resources efficiently, and mitigate risks. Attendees will also be able to enhance their ability to handle complexities and minimize delays, ensuring timely study initiation. This session is ideal for clinical research professionals aiming to improve start-up efficiency, as it will offer practical takeaways, including templates and checklists, to apply immediately to their work. Speakers: Tamika Harris, Clinical Operations Manager – Regulatory, Merck; Jessica Propps, ACRP-CP, Clinical Operations Manager – Regulatory, Merck
Your patient recruitment engine is the machine that fuels your site’s success. Regardless of your wins or losses, every site wants to improve and add efficiency to its recruiting process. Chances are, a lot of what you’re already doing is right, but there seems to be something new every day that clinicians can’t resist seeking–the next “silver bullet” for marketing and recruiting. It’s easy to feel you’re behind in the space. It’s easy to think you’re over- or under-invested. It’s easy to ponder that others are finding patients you’re not. This session is designed to ease those fears. Find out about the things you think you might be missing. We’ll discuss the media options sites are using, spend some time on the new things you keep hearing about, and give you the tactics to evaluate your recruiting operation. Then you can decide where best to allocate resources and grow. Speaker: Mark Metzner, Senior Manager, Patient Recruiting & Feasibility, CTI Clinical Trial Services, Inc.
Join ACRP’s Executive Director and board members in a town hall setting for an open mic event that will geaux beyond a typical conference kick-off! We’ll explore the importance of community, connection, and maintaining confidence in uncertain times and invite you to bring your experience and best ideas to support your colleagues during demanding times. Let’s convene to talk strategies for coping and use the power of networking to support our community of clinical research professionals. Speakers: Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President, Clinical Research, Northwell Health; Catherine Gregor, MBA, CCRC, Chief Clinical Trial Officer, Florence Healthcare; R’Kes Starling, RPh, MBA, Chief Executive Officer/President, Reveles Clinical Services; Susan P. Landis, Executive Director, Association of Clinical Research Professionals (Moderator)
Translational research is often driven by independent physician-investigators who want to bring medical innovations to the bedside. These pioneers take on the design, implementation, and compliance needs of their clinical trials, often without any formal training on research methodology. Similarly, lack of formal regulatory training creates challenges for busy investigators balancing their clinical and research responsibilities, and can put institutions at an increased risk of non-compliance, loss of reputation, and liability. Establishing an investigator-initiated research program (IIRP) can address the knowledge gap, foster translational research, and provide a support model that improves the quality of research, enhances reproducibility of results, and ensures compliance while protecting the rights of and maximizing the potential benefits for research participants. The session will focus on the importance of an IIRP regardless of research portfolio size, will deliver scalable steps for success. The example of a bottom-up approach will provide a framework for discussion and opportunity to share lessons learned. Speakers: Pamela Cooper, Manager, Investigator Initiated Research Program, Hackensack Meridian Health Inc; Elli Gourna Paleoudis, PhD, Director, Investigator Initiated Research Program and Support Services, Hackensack Meridian Health
For more than a decade, multiple sources of regulatory guidance have increased their focus on risk management in clinical studies, paving the way for industry to adopt more risk-based monitoring strategies internationally. With the issuance of ICH E6(R3), an even more focused risk-based approach is expected. While Industry initially struggled to implement risk-based monitoring, moving review into central/remote scenarios as opposed to traditional onsite monitoring, we can now apply lessons learned to various indications and phases of research. We’ve come very far in tailoring systems and approaches to fit the needs of studies while still building in quality by design. Sites are important partners, but have been left out of the conversation about risk-based monitoring. Industry has fallen short in making risk-based monitoring something tangible to sites. Our goal is to bring sites a greater understanding of what sponsors/contract research organizations (CROs) are looking for, how they develop their key risk indicators, and how their ongoing monitoring and mitigation strategies impact their studies. Speakers: Sara Croteau, Associate Director, Clinical Operations – Quality Management, Innovaderm; Valerie Paolella, Associate Director, Clinical Trial Management, Innovaderm
In this session, we will explore the often-overlooked financial and operational costs associated with implementing diversity and inclusion (D&I) practices in clinical research and practical strategies to mitigate these costs. While the benefits of D&I are widely recognized, understanding and addressing the hidden costs can help organizations create more effective and sustainable strategies. By enhancing their competencies and skills in this area, attendees will be better equipped to implement effective and sustainable D&I practices in their organizations. Speakers: MaryAnn Bowman, Founder / CEO, ClinGRO Solutions; Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
Research sites often grapple with the complexities of disbursing participant stipends and reimbursements. These challenges stem from unclear stakeholder roles, diverse payment methods (e.g., reloadable cards, cash, checks), federal tax rules, guardianship issues, and ethical considerations for providing payments for clinical trial participation. To address these hurdles, this session will explore creative approaches in this arena, including diverse methods for handling reimbursements, sponsor budget negotiation tactics, and technology systems for efficient and compliant management. The session will emphasize the importance of adhering to federal regulations while considering institutional organizational structures, such as centralized or decentralized management of payments and reimbursements. The session will also give attendees the tools and strategies to determine the best solution for their organization. Speakers: Samantha Herbst, Manager, Huron Consulting Group; Shreya Singh, Senior Associate, Huron Consulting Group