This package is a replay of 62 on-demand session recordings and presentation slides from the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. It includes content from the five educational tracks, the Signature Series sessions, Rapid-Fire session, and techXpo 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 Courses Dashboard. Replay sessions expire on May 31, 2026.
In 1986, the NIH wrote a memo encouraging the inclusion of women and minorities in clinical research. Five years later (1991) the NIH established the Office of Research on Women’s Health. But it wasn’t until 1993 that inclusion of women and minorities in clinical research became federal law to ensure that: Women and minorities are included in all clinical research. Trials should be designed and carried out so that it is possible to analyze whether the variables being studied affect women and minorities differently than other participants. Discover the many ways that women are shaping the field of clinical research—through professional leadership positions, advocating for female representation in clinical research, ensuring research studies on diseases that impact those who identify as female, and ensuring that women of color are included in studies and trials. Join a diverse and esteemed panel of women who will speak to progress in clinical research for women and who will inspire us all to advocate for women in clinical research. Speakers: Rose Blackburne, MD, MBA, Vice President, Global Product Development, PPD; Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Instructor of Clinical Practice, The Ohio State University; Jeanne Taylor Hecht, CEO, JTH Consulting & Associates; Virginia Nido, Global Head, Product Development Industry Collaborations, Roche; Deb Tatton, President, Global Clinical Operations, Parexel.
Dr. Burnett will share stories of her own journey with cancer, take us through a brief history of innovative healthcare disruptions which are essential to modern medicine, and discuss why continued innovation through clinical research is both essential and endlessly appreciated by patients and physicians alike. Speaker: Courtney Burnett, MD, Physician, Writer, Brain Cancer Thriver
We all agree that we need to work together to improve diversity in trials—right? But how do we move from EDI as a recommendation to a requirement? In an era of heightened awareness of systematic and structural racial injustice, how do we apply social justice models to ensure a fair and equitable division of resources, opportunities, and privileges in clinical trials? There are multiple ways. Sites can advance diversity through staffing. Sponsors can develop next generation protocols that build on advances in decentralized trials made during the COVID-19 pandemic. Join our panel of experts at ACRP 2023 to deepen your understanding of diversity, equity, and inclusion in clinical research and learn about models making a difference. Take home lessons learned from effective strategies you can champion in your organizations and communities to make clinical research more inclusive. Speakers: Nadine Barrett, PhD, MA, MS, Assistant Professor, Family Medicine and Community Health, Duke University; Quincy J. Byrdsong, EdD, CIP, CCRP, Vice Provost, Health Affairs, Lipscomb University; Kristin Smedley, Co-founder, Thriving Blind Academy; Audrey Cavenecia, Chief Experience Officer, Reveles Clinical Services (Moderator)
“If you want DCTs to work, look to the workforce,” says Michelle Longmire, CEO of Medable. Clinical research professionals are key to the success of DCTs. Your experience of implementing decentralized trial components must be considered in framing solutions for accelerating the adoption of DCTs. Join ACRP as it reviews the results of our community survey about DCTs, and hear perspectives brought forward at last year’s ACRP DCT Think Tank sponsored by Advanced Clinical, Medable, and Syneos. Bring your insights to this interactive session as we empower the clinical research workforce to help transform clinical research. Speakers: Mohammed Ali, Chief Domain Expert, Decentralized Care, Medable (Moderator); Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare; Paul Ivsin, Senior Vice President, Analytics, Insights & Media, Continuum Clinical; David Morin, MD, FACP, CPI, FACRP, Director of Research, Holston Medical Group; Caroline Redeker, SVP, Corporate Development, Advanced Clinical; Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, RWE Clinical Trials, Walgreens
Whether it’s a new therapy, a novel idea for making clinical trials more efficient, or a new program to improve workforce retention, anyone—and everyone—can be a disruptor. In a recent story in The Atlantic, author Derek Thompson makes the case that invention alone cannot change the world. The key is in implementation of the idea and recognizing that progress is actually a timeline of breakthroughs. In this session, you’ll hear about the sparks that inspired disruptive ideas and signals that kept disrupters dedicated to achieving their vision. We’ll share how perseverance pays off—for clinical trial transformation and, especially, for patients. Speakers: Mohammed Ali, Chief Domain Expert, Decentralized Care, Medable (Moderator); Joy Bhosai, MD, MPH, Co-founder and CEO, Pluto Health; John Campbell, Head of Decentralized Clinical Trials, Walgreens; Jen Horonjeff, PhD, Founder and CEO, Savvy Cooperative; Scott Kollins, PhD, Chief Medical Officer, Akili Interactive; Del Smith, PhD, Co-Founder and CEO, Acclinate
According to the Code of Federal Regulations, research should be designed to develop or contribute to generalizable knowledge. It should be undertaken with a goal of learning something. However, a large portion or research does not profess to that goal. Instead, many projects state an aim of performing the research, not that of increasing knowledge. They use process-oriented “objective’ statements instead of goal-oriented ones. A recent look at 100 consecutive objective statements in ClinicalTrials.gov submissions found only 34% of the “objectives” expressing a goal. The majority just convey a goal of performing a study. An objective of “to investigate…” or “to evaluate…” does not convey a quest to increase knowledge like “to determine…” or “to identify…” While this may seem punctilious, we feel the proper use of objectives can increase confidence in the research team. As the research objectives often provide the first impression of the project, accurately presenting them seems to be desirable. If we want to find whether an investigational drug is safe and effective, we would want to “determine” that, not just “assess” it. We should not be satisfied asking the question, we should want to answer it. This session will help the audience recognize objective statements that do not adequately express the goals of the project, and help attendees assist in constructing statements that are accurate in presenting the desired goals. Speaker: Richard Ogletree, PharmD, Research Coordinator, AIS HealthCare
Site technology is expanding. This session will use market trend data to guide sites and sponsors on who should pay for, own, and control technology that connects research teams. It will help managers at both sites and sponsors understand what tools are available to improve site connectivity and will share best practices on adopting technologies that help sites work with sponsors and vice versa. Speaker: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
This session is intended for Sponsor and Site personnel interested in learning more about the importance of Chain of Custody of Investigational Products. Learners will take away a better understanding of the rationale behind why the chain should not be broken. Speaker: Dawn Partridge, Country Clinical Quality Manager, Merck
In recent years, the need for increasing racial and ethnic diversity of participants in clinical research has important goal for study sponsors and regulatory authorities. A diverse study population is essential for quality clinical research results that can be generalized to the population. Clinical research site personnel and investigators may have insights on ways to improve diversity in clinical trial enrollment and may be using new techniques for improving the participant experience. This program will discuss the results of a mixed methods survey study describing current clinical research site practices and perspectives on racial and ethnic diversity in clinical research. This information will empower sponsors, CROs, vendors, and sites alike to understand gaps in facilitators and barriers to recruiting diverse participant populations, leading to insights that may influence practice change. Speakers: Carolynn Jones, DNP, MSPH, RN, FAAN, Associate Professor-Clinical, The Ohio State University; Demi MacLennan, MS, CCRA, ACRP-PM, Clinical Trial Project Manager, Labcorp Drug Development; Jennifer Plahovinsak, MS, DABT, Director, Master of Science Translational Pharmacology Program, The Ohio State University
Participants will gain key insights, best practices, and simple tactics for advancing the medical and scientific knowledge base of their clinical research professionals. By increasing therapy area knowledge, CRAs will be able to more effectively monitor complex clinical trials, speak the language of the clinician, and deliver high-quality support of site personnel. Speakers: Jennifer Berdovich, PharmD, BCOP, Senior Director, US Medical Affairs, Merck Research Labs, Merck & Co., Inc.; Kelly Clark, BScN, MSHS, Head of US Partnerships and Global Site Development, Merck; Maximiliano Elizari, MSc, Senior Clinical Research Director, Merck
It is easy to become lost and burdened with regulations which were originally designed to protect us from repeating research abuses of the past. We can easily forget that history and why the system of research protections in place today exists in the form that it does. In this session we will take a tour through the history of research, the foundations of the Belmont Report, and explore the ethical underpinning of our research ethics review systems. We will also explore contemporary research ethics issues. Speaker: James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra
The recently adopted ICH E8 (R1) encourages sponsors to “create a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to quality for a particular study or development program”. Although unspoken, with this remit comes the responsibility to not only create a culture, but organizations must periodically monitor the progress or status of the culture that has been created. In this session, case studies will illustrate how existing quality metrics can be used to monitor an organization’s culture of quality and its impact. The case study will include: an analysis of established quality metrics over time and an action plan linked to quality culture enablers (e.g., critical thinking and open, proactive dialogue) designed to achieve the quality outputs that uphold patient safety, data integrity. Speaker: Leslie Sam, BA, LSS BB, CIQ, President, Leslie Sam & Associates
Have you ever wondered how many trials a clinical research coordinator can or should be able to handle? If you are basing your decisions on management instinct, please come to this session prepared to take the guesswork out of assigning trials. In this talk, we learn about a practical tool that can help you assign trials based on clinical research coordinator workload. In addition, relevant revenue information collected as part of the tool utilization can also highlight what studies may be more beneficial or lucrative for your site to conduct. Speaker: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford Hospital
DID YOU KNOW… …in today’s clinical research world it’s hard to keep up, let alone answer all the questions we receive from our staff, sites, and others we work with. It is difficult to keep track of all the information we need to remember to do our jobs, but YOU can make a BIG difference and bring ENORMOUS value by becoming a knowledgeable resource and information “library.” Even if you don’t have all the answers, learn how to become an invaluable resource to your colleagues AND a huge motivator and leader. Knowing where to look will not only make you an MVP but can propel your team to the next level. Examples of information communications, knowledge libraries, and leadership tools will be shared. Speaker: Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Operations Strategy and Training Director, ProTrials Research, Inc.
This session focuses on a systematic approach to resource allocation that results in adequate, trained, and flexible staff to support study operations. Those involved in resource allocation, operationalizing studies or supporting study operations will gain insight into an approach that they may consider implementing in programs that they support. Speakers: Adrianna Byrnes, PhD, Protocol Navigator Manager, Frederick National Laboratory for Cancer Research/Leidos Biomedical; Jennifer Jo Kyte, DNP, APRN, ACNS-BC, CCRN, Supervisory Research Nurse Specialist, National Institutes of Health
The interdependent, inverse relationship between risk management and knowledge management will be explored. In practice, the evidence of this understanding in clinical development is not obvious. With better integration of the complimentary quality management system enablers, there is an opportunity to better manage risk and thus increase patient protection. In this session, attendees will examine the details of the infinity cycle framework and its application to clinical development lifecycle phases. A strategic approach to knowledge management will also be explored. Speaker: Leslie Sam, BA, LSS BB, CIQ, Principal Consultant, Risk Management and Issue Management Practice Lead, Wool Consulting Group
Successful research depends on the teamwork of several key individuals, representing differing project priorities and institutional requirements. In this session, we aim to present strategies for navigating the research administration process at your institution so that projects can more quickly obtain approval for site initiation. Drawing from our experience with galvanizing teams to conduct longitudinal, virtual research at a large academic medical center, we will provide tips on preparing for and executing the research process. We will focus on communication with stakeholders and discuss best practices for across-aisle collaboration with sponsors, researchers, and administration. Speakers: Stefani D’Angelo, MS, CCRC, CHES, Senior Clinical Research Manager, Northwell Health/Feinstein Institutes for Medical Research; Challace Pahlevan-Ibrekic, MBE, CIP, Director, Clinical Research, Northwell Health/Feinstein Institutes for Medical Research
The Renown Health-University of Nevada, Reno School of Medicine signed an affiliation agreement in June of 2021 creating Nevada’s first integrated health system, with expansion of clinical research opportunities for patients as a core pillar of the affiliation’s mission and indicator of success. This presentation focuses on the importance of a strategic communication and marketing plan in the context of ambitious development goals in clinical research. The discussion will also address the leadership and teamwork skills necessary to bring visions for clinical research to life in communities with minimal understanding of the purpose and benefit associated with clinical trials. Speakers: Danielle Eaton, Director of Clinical Research, Renown Health and University of Nevada, Reno School of Medicine; Kristen Gurnea, MPH, CCRC, ACRP-PM, Manager of Clinical Research, Renown Health
Who is responsible for community engagement? The answer is, unequivocally, all of us. This session will discuss the necessary and unique role of each stakeholder (sponsors, CROs and sites) in community engagement work and how we hold each other accountable. We must accept that the strategies we have embraced in the past must change to engage minority communities and that we all must be committed, and we must hold each other accountable for community building. For there to be real change in the way that underrepresented communities are included in clinical research, the nonprofit and community organizations serving communities must play an active role in the outreach/engagement to these communities. Learn how to involve those grassroots leaders who hold the answers to the question, how do we engage minority communities? Speaker: Ashley C. Moultrie, CCRP, Director of DEI & Community Engagement, Javara
Our industry has struggled to create streamlined workflows that meet regulatory requirements, align with SOPs, work within protocol restraints, and meet the needs of sponsors/CROs in an efficient manner. The push for decentralized trials adds another layer of complexity to trial operations. Sponsors and CROs have a desire and a responsibility to secure high-quality data while minimizing delays to study timelines. This session will discuss opportunities for sponsors and CROs to leverage industry technology as a platform to help sites streamline workflows while increasing sponsor/CRO visibility into study progress. Benefits of increased project oversight to areas such as risk management, data quality, study timelines, audit readiness, and budgets will be explored. Speaker: Kristin Surdam, MS, PMP, CCRC, Senior Director, KOL & Strategy, Florence Healthcare
Community Engagement is not the same as patient recruitment/engagement, yet many professionals use the terms interchangeably and don’t create actionable plans that delineate them. In this session, you will hear why there is a need to think about community engagement differently and how you can begin to create balanced strategies and tactics that can lead to better awareness and trust within the community that leads to greater diversity and inclusion. Speaker: Chris Komelasky, CEO, SiteBridge Research Inc.
Over the past ten years, over four million dollars have been invested internally to support the growth of clinical research at Nationwide Children’s Hospital. As a result, numerous clinical fellow and faculty have secured external grant funding related to their intramural project—including NIH funding. In 2021, 16 scientific publications can be attributed to this investment and 28 fellows, residents, and faculty have presented their results at more than 35 conferences and seminars. The academic and scientific return on investment remains high and continues to grow year over year. Attend this session to learn how to build a program that builds better researchers and kickstarts research careers! Speaker: Samantha Sharpe, CCRP, Senior Program Administrator, Nationwide Children’s Hospital
David Burrow from FDA’s Center for Drug Evaluation and Research discusses key opportunities to build quality into clinical research, and strategies to make the FDA inspection experience a positive one. David will describe the impact inspections can have on marketing applications, and how Quality by Design will help minimize the prevalence of errors that matter. When problems do occur, inspected entities should be able to respond appropriately. In this session, you will also take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
This session will highlight key laws and regulations (or the absence of laws and regulations) that directly or indirectly affect the research industry. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA
Remote Monitoring is a hot topic. The core business challenge is the expense of remote monitoring vs onsite monitoring, and the core competency challenge is confidentiality during remote monitoring. This is important for the audience to learn and/or address in order to make remote monitoring go more smoothly. This will help the study team increase monitoring productivity and lessen the financial burden of onsite monitoring. Professionally, the CRA and the site must be able to communicate and work together to obtain the same results during the remote visit as occurs during an onsite visit. Speaker: Kristi Pinkston, BS, RN, MABC, Senior Clinical Research Associate, Merck
In this session, we will discuss the FDA’s Bioresearch Monitoring Program (BIMO) inspections and how future inspections may look a little different than they did before. Learning Objectives: Be prepared for an FDA inspection; Learn some new technologies which may be employed during inspections; Learn how we are adapting to new technologies to ensure our CSOs are prepared. Speaker: Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs
This interactive session is intended for experienced professionals who deal with complex issues, need to understand the latest developments, and can contribute their own experiences. We will cover important GCP topics to prepare for audits and regulatory inspections and for addressing inspectional/audit observations. Discussions will include how to create Corrective And Preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters, NIDPOEs and 483s. Speakers: Glenda Guest, CCRA, RQAP-GCP, TIACR, FACRP, ACRP-MDP, President, Assured of Quality Consulting & Training; Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer
Are you a clinical site, CRC, CRA, or another member of the research trials team who would like to gain more exposure and knowledge of medical device trials? Are you interested in learning more about how pharma and device clinical trials are similar and different? Join this session to learn more about medical device trials, how the monitoring of trial data may be different, and what a typical day in the life of a device CRA looks like. Attendees will walk away with practical knowledge and monitoring tools, such as a Monitoring Visit Checklist. Speaker: Sherry Roberts, BSN, RN, CHPE, CCRC, Lead Clinical Trial Specialist, Stryker
All professionals involved in the Management of Clinical Research at the Sponsor, CRO, or Site level will benefit from this session. Oversight is a growing activity that is required of all Sponsors of Clinical Trials in compliance with ICH GCP Guidelines that enable governance and risk mitigation while supporting the study’s overall quality strategy and ongoing improvement. Speakers: Anne Blanchard, CCRA, CPM, FACRP, Clinical Operations Executive Consultant; Mary Lord, RN, MS, CCRA, CRA Manager, Site Management and Monitoring, Merck
This session will help anyone who is a research professional to understand what the risks are in billing compliance. Inspect your program, measure risks, and assemble the team who can make billing compliance better. Speaker: Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, Manager, Kelly Willenberg & Associates
Expanded Access (EA), also known as “compassionate use”, is increasingly in the news, and sponsors are increasingly looking to mine “real world data” (RWD) from these treatment programs, which involve patients, not research participants. We will define these terms and describe opportunities and limitations for collecting data from EA. Listeners will become familiar with the ethical, data quality, and regulatory questions surrounding the collection and use of RWD from EA. This session’s content is relevant to any individual interested in learning more about real-world data generated both within and outside of EA, and how to evaluate RWD as a potential source of real-world evidence (RWE). Speakers: Alison Bateman-House, PhD, MPH, MA, Assistant Professor, NYU Langone Health; Hayley Belli, PhD, Assistant Professor, NYU Langone Grossman School of Medicine
As more patient advocacy groups are undertaking their own research, such as natural history studies and patient registries, it is more important than ever to make sure patient advocates functioning in the researcher role, understand good clinical research practices. For patient advocates who may be new to clinical research, it is important that clinical research education is accessible and easy-to-understand. In this session, we will share techniques for developing an education program for the needs of these novice researchers, that guides them in good clinical research practices, while allowing the patient advocate to customize their research strategy to the unique needs of their research community. Speakers: Stephanie Christopher, MA, CCRC, FACRP, Director, Patient Advocacy, Pfizer; Janet Mauro, BA, CCRC, IAMRARE® Implementation Co-Lead, National Organization for Rare Disorders
One common element between every single study is that they are run by people. People talking and communicating to other people. Sponsors, site staff, medical staff and clinical monitors all need to communicate together to update, inform and resolve issues. But where is the training for this? Why do we, as an industry, not focus on improving our soft skills as well as our hard skills? Learn the value and the power of having trained in soft skills. The speaker will present the current status quo where soft skills training barely exists (if it all) and what impact that has on people and studies and then compare that to an alternative view where study teams are given the appropriate soft skills training. The audience will get insight into how things should be; where there are less deviations, less churn of staff and more efficient studies are conducted. Speaker: Agnieszka Finlayson, MSc, MA, Director and Founder, White Wisteria Academy
Workforce development is a topic that applies to all roles in clinical research including investigative sites, CROs & sponsors. The attendees will gain a new perspective on the topic, its current state & how to reach its desired state. We are hoping to bring the latest research on the topic, share it with our audience & gather perspectives from all participating stakeholders. Speaker: Shayan Bashir, Clinical Research Associate, Premier Research
The demand for skilled clinical research professionals remains at an all-time industry high. As clinical trials continue to take multiple forms and require diverse skills, identifying competent personnel remains a challenge. The pathway to gaining the required skillset for job performance is not clearly defined. This session describes two leading practices for gaining knowledge, training, certification, education, and competency in clinical research, as outlined by the Joint Task Force (JFT) in the core competency framework. Speakers: Susan P. Landis, Executive Director, Association of Clinical Research Professionals; Erika Stevens, MA, FACRP, Principal, Recherche Transformation Rapide, LLC
Defining key barriers to the development of a well-trained clinical research professional workforce is an essential first step in identifying solutions for successful recruitment, onboarding, and retention. We analyzed qualitative data from a series of breakout sessions and open-text surveys to explore these complex issues. Competency-based frameworks for job descriptions and standardization within and across institutions remains lacking. Several barriers include balancing foundational onboarding; managing logistical challenges and institutional contexts; identifying/enlisting institutional champions; assessing competency; and providing high-quality mentorship. The urgent need to close gaps in workforce turnover, attracting more diverse applicants, and improving professionalization of the clinical research professional career pathway is crucial. Speakers: Stephanie Freel, PhD, PMP, Director, Clinical Research Education & Outreach, Duke University; Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Instructor of Clinical Practice, The Ohio State University; Carolynn Jones, DNP, MSPH, RN, FAAN, Professor of Clinical Nursing and Director of the Master of Clinical Research, The Ohio State University, College of Nursing; Mark Marchant, MBA, MPH, Director, Clinical Trial Administrative Office, The University of Alabama at Birmingham; Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine
Team science competencies for clinical research professionals are poorly defined, yet the operations and management of clinical trials require CRPs to work across disciplines, departments and systems to get the work accomplished. CRPs require an understanding of team science and effective teaming. The JTF Competencies rarely cover these aspects. We formulated a workgroup to define CRP team science competencies including skillsets for individuals and teams. We used a modified Delphi approach, created a leveled (fundamental, skilled, and advanced) competencies for CRPs based on a team science model consisting of 5 individual team science domains and 8 team domains. We will present this work in detail and highlight team science competency building as an important element for staff satisfaction and effectiveness. This should stimulate new training initiatives CRPs. Speakers: Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Instructor of Clinical Practice, The Ohio State University; Carolynn Jones, DNP, MSPH, RN, FAAN, Associate Professor – Clinical, The Ohio State University
Are you looking to break into a career in clinical trial operations? Or is your organization looking to grow their bench of early talent in the clinical trial operations space? This session will provide insights from one clinical trial operations organization about how they created roles and programs to attract, develop, and retain diverse early talent team members, and the benefits of these programs. A panel of early talent team members will then share how they were able to leverage their skills gained from their prior roles, and the factors that helped them transition into their new roles and keep developing and growing within the clinical trial operations space. Attendees will take away best practices for either developing or pursuing early-career clinical trial operations roles. Speakers: Kim Diaz, BS, Associate CRA, Merck & Co.; Kimberly Jochman, PhD, RAC, Senior Director, Medical Writing, Merck & Co.; Christopher Quaglia, BS, MS, Study Manager, Merck & Co.; Albert Yen, PhD, Associate Medical Writer, Merck & Co.
If you’re a clinical research professional who trains or manages others, or are interested in site-based workforce development, this talk is for you! Speakers will discuss the importance of standardized onboarding training and assessment for new clinical research employees, and how traditional classroom and virtual learning alone may not be enough to ensure competency and confidence in the workforce. Gain strategies and resources to help you develop and expand practical, peer-to-peer, and leader-to-team training. With a mix of site-based clinical researchers and Learning and Development experts, this session will help you better address training challenges, leading to stronger culture, and higher employee retention. Speakers: Mallory Frazier, Manager of Training, Javara; Lauren Fregonese, Senior Director of Learning and Development, Javara; Nicole Saladino, Account Development Associate, Javara; Anita Wood, Senior Clinical Trial Navigator, Javara
Although decentralized trial (DCT) elements have been around for years, the pandemic accelerated DCT and hybrid designs “back to the future,” a paradigm shift predicted to continue. While clinical trial regulations do not change just because trials are decentralized, there are increased cybersecurity risks that need extra scrutiny. Academic Medical Centers (AMCs) face similar roadblocks to industry when incorporating DCT elements into their study designs, with a few notable differences that will be presented. AMCs are doing more with experimental technologies, including telemedicine, smartphone apps, sensors, text messaging, chatbots, traveling nurses, and collecting primary efficacy variables through ePROs. Practical tips and suggestions will be given for working with AMCs, and trials of the future, to design and execute digital and hybrid DCT approaches outside of the traditional brick-and-mortar research site. Speakers: Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Executive Director, Utah Trial Innovation Center, University of Utah; Jamie Dwyer, MD, Professor of Medicine, Associate Dean of Clinical Research, CRSO, Medical Director, University of Utah; John Van Buren, PhD, Assistant Professor, Family & Preventive Medicine – Adjunct Assistant Professor, Population Health Sciences – Adjunct Assistant Professor, University of Utah
There are alarming staff shortages and turnover rates for clinical research professionals (CRPs), negatively impacting research activities. Recent publications have identified potential factors that may improve retention and job satisfaction amongst clinical research coordinators such as PI engagement, and compensation; however, job satisfaction data lack granularity to explore factors deeply. We conducted a mixed methods research study to further explore job satisfaction and retention, soliciting survey and open-ended qualitative responses from CRPs working at clinical trial sites. This study will validate correlative findings associated with job satisfaction and retention of clinical research professionals, identify new characteristics that may be associated with clinical research professional retention, and aid in developing further research and solution-finding. In this presentation, we will share our study findings and facilitate discussion for targeted and widespread solutions. Speakers: Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Instructor of Clinical Practice, The Ohio State University; Carolynn Jones, DNP, MSPH, RN, FAAN, Associate Professor – Clinical, The Ohio State University; Spencer Harris, Clinical Research Coordinator, The Ohio State University
In an age when the clinical research workforce is dwindling, lacks proper training, and is expected to assume more responsibility than ever before, it is time for sites to meaningfully address workforce development and reimagine the way clinical research departments function in the context of their organizations. This interactive session will analyze the career trajectories that bring individuals to clinical research and delve into the key onboarding and training dynamics required for retention. Attendees will receive Clinical Research Coordinator training toolkit materials and will discuss actionable initiatives to produce stability in the clinical research workforce. Anyone interested in the development of the clinical research workforce should attend this session as we analyze strategies for site staff stability and growth from a variety of perspectives in a rapidly evolving landscape. Speakers: Katie Buckley, Clinical Research Coordinator, Renown Health; Kristen Gurnea, MPH, CCRC, ACRP-PM, Manager of Clinical Research, Renown Health; Lisa Lionetti-Freutel, CCRC, Clinical Research Coordinator, Renown Health; Valerie Smith, Clinical Research Center Administrative Manager, University of Nevada, Reno School of Medicine
As we all know, the field of clinical research is governed by multiple sets of regulations, rules and expectations set by a variety of different governing bodies. While these rules are necessary to ensure the safety of patients and quality of studies, it often means we get in the habit of “doing things as they’ve always been done.” This session will explore and promote opportunities for creativity and innovation within clinical research on a personal, company-wide, and large-scale scope while maintaining compliance with strict regulations. Some areas of focus include internal innovation opportunities, technology and data-driven advances, working efficiency methods, and more. We invite everyone to join, listen, and actively collaborate on ideas to expand the field of clinical research within your company or your own practice. Speakers: Morgan Heck, Associate Clinical Research Associate, Merck; Kayla Perry, Associate Clinical Research Associate, Merck
Clinical Research Professionals are under increasing stress as timelines are shortened, more work is being done remotely, and worker shortages are commonplace. You may have experienced the agony of working alongside someone who makes you feel frustrated and cranky. Conflict in the workplace is common. Resolving conflict takes planning, being open-minded, and acting whole-heartedly. Come to this session to learn how to plan a resolution discussion. Speaker: Mary Lord, RN, MS, CCRA, Associate Director, Merck
Effective public speaking and communication practices are integral to clinical research training/education. Critical study information is delivered to clinical research associates, investigational site staff and study patients on a regular basis, yet the content is only as strong as the educator delivering the message. This presentation will provide critical insight on how to effectively capture and sustain the clinical research audience with a powerful message, engage and sustain interest with measures on powerful body language, intonation, and storytelling, and ensure the message content is understood and retained through positive presentation strategies. This in turn will assure accurate implementation of clinical research process to positively impact credible data, patient safety and overall study conduct. Speaker: Elizabeth Weeks-Rowe, LVN, CCRA, Clinical Research Trainer/Writer, Clinical Research Writing and Training
Are you having trouble communicating with your study site or team? Seems like you all aren’t on the same page? Look no further! “Communication and Teamwork” will help get you back on track. This session will teach you how to effectively communicate with the other side. You will learn how to identify when a lack of communication is present; develop an action plan and implement that plan to foster a cohesive environment to close the communication gap. Speaker: Carmen Thornton, Senior Clinical Research Associate, Merck
This is “Jeopardy!”. With us in the room are today’s volunteer contestants from the Site, Sponsor and CRO. It’s time to find out which savvy group can identify the most acronyms and abbreviations commonly used in Clinical Research. Our six categories include: Clinical Trial Operations / GCPs, Study & Site Management, Ethical & Participant Safety Considerations, Data Management, Informatics & Tech, Scientific Concepts & Research Design and Anything Goes! Are you ready to test your Clinical Trials knowledge? To the top group we provide conference bragging rights as to who is more knowledgeable – the Site, the CRO or the Sponsor. Speaker: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford Hospital
The principles of cultural humility can be summarized by a quote from H. Jackson Brown Jr, “Remember that everyone you meet is afraid of something, loves something and has lost something.” Cultural humility means admitting that one does not know and is willing to learn from their research team colleagues and study subjects about their experiences, while being aware of one’s own backgrounds, beliefs, and experiences. This presentation is important for anyone involved in clinical research, to gain insights on how to use cultural humility as a tool to support all members of the research team and enhance their recruitment efforts of diverse study subjects. Speakers: Jessica Fritter, MACPR, ACRP-CP, Associated Faculty, Instructor of Clinical Practice, The Ohio State University; Bashar Shihabuddin, MD, MS, Assistant Professor, Nationwide Children’s Hospital
Standing out among the crowd to attract and retain top talent is challenging in today’s rapidly changing and highly competitive labor market. During this session, Brad Sibbald, Senior Vice President, Kelly Science & Clinical, will share five strategies to differentiate your organization. You will learn how to build a stronger employer brand and effectively communicate your unique value proposition, and how to cultivate partnerships that help you tap into a wider pool of top talent. Brad will share expert insights on the critical role of skills development to attract and retain talent, how diversity, equity and inclusion (DEI) initiatives can create a more welcoming and productive workplace, and how an agile workforce strategy positions your organization to outperform the competition. Speaker: Brad Sibbald, Senior Vice President, Kelly Science & Clinical
It is important for clinical research professionals to listen to the patient perspective in order to appreciate the multisector landscape of the field. In this presentation, speakers with come together to discuss shared accomplishments and unique challenges. This will not only be very engaging for the attendees but will also provide a deeper understanding of the complexities of incorporating DCTs in the clinical trial industry. Discussions like this one kinder a collaborative approach. Attendees will walk away with a more holistic sense of the challenges that we face, and the amazing possibilities as clinical trials increasingly move towards DCTs. Speakers: Jane Myles, Vice President of Clinical Trial Innovation, Curebase; Noor Salman, MSC, CCRC, Clinical Research Coordinator, Mount Sinai Hospital; Kaushal Shah, PhD, Associate Director, Clinical Associate Professor, Arizona State University; Alicia C. Staley, Vice President, Patient Engagement, Medidata
Clinical research professionals tasked to develop strategies, plan clinical trials and decide on how to leverage the use of technologies will gain in-depth insights and tactics on how to streamline their decision-making process through lessons learned from actual cases and toolkits. Speakers: Nadina Jose, MD, Assistant Professor, School of Health Professions, Rutgers, The State University of New Jersey; Avik Pal, CEO, CliniOps Inc.; Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, RWE Clinical Trials, Walgreens
Clinical research is undergoing a fundamental shift towards longitudinal evidence generation, which will change expectations for how research sites conduct clinical studies. Throughout COVID, and across rare diseases, cancer, and now even Alzheimer’s, we’ve seen products are coming to market sooner, with greater reliance on post-market data to inform regulatory decisions. This has increased the demand for clinical studies that follow participants across time while combining real-world data and clinical trial data. This general interest/ hot topic session will provide attendees with an understanding of these changes underway, and how this shift will impact clinical research sites. We’ll share case examples of sites conducting longitudinal studies and will speak to learnings from these experiences to inform how clinical research professionals can plan for the future. Speaker: Brad Hirsch, MD, Head of Product & Implementation, Verily
Have you become increasingly frustrated by the technology burden in Clinical Trials? Are your CRC’s or CRA’s drowning in Portal Accesses? This session on optimizing technology will bring a Site Network’s perspective on how we can best evaluate, implement and re-evaluate technology use at all stages of the trial and patient journey. You will first be oriented to the current challenges with technology use, then be guided through recommendations for developing a technology strategy that can help to leverage platforms to work for you rather than against you. Speaker: Lydia Beaudette, MSc, ACRP-PM, MBA, Director – Growth & Strategic Partnerships, Centricity Research
Learn ways to improve the patient experience and simplify trial conduct for sites through technology that makes it easy to share information. Hear case studies and real-world examples of how a connected trial ecosystem that spans patients, sites, and sponsors improves information sharing and collaboration, and ultimately, the patient experience. Speakers: Bree Burks, RN, MSN, VP of Strategy, Site Solutions, Veeva Systems; Natalie Morrow, MSc, Head, Regional Managers, Alcon; Adam Samson, MS, PMP, CCRA, CCRC, CCDM, Head of Clinical Delivery Operations, RWE Clinical Trials, Walgreens
Regulatory requirements are often interpreted as hurdles and blockers to technological innovation. Recently, this type of thinking has shifted – particularly during the pandemic – as regulators have embraced technology to streamline and improve the conduct of clinical trials. During this presentation, an outline of regulations and guidance will be presented and a set of practical actions will be discussed to help organizations ensure compliance when implementing eSource solutions. Speaker: Marc Wartenberger, CQA, CTFL, Director, Corporate QA and Compliance, CRIO Inc.
Designed for clinical research professionals in biopharma companies, academic and community-based sites currently faced with adopting the use of decentralized models. Guidelines, tools, and suggested workflow templates will be provided. Speakers: Nadina Jose, MD, Assistant Professor, School of Health Professions, Rutgers, The State University of New Jersey; David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare
This one-hour session features a series of five-minute presentations on hot topics in clinical research. These dynamic, “rapid-fire” presentations are designed to differentiate between myth and fact, provide guidance on hot topics and offer fun inspirational stories. This session does NOT offer ACRP Contact Hours. Presentations include:
The lack of diversity in clinical trials is an age-old problem. The mounting escalation of this challenge exposed by the COVID-19 pandemic is requiring the pharmaceutical industry to identify new solutions to address clinical trial diversity. Learn how Merck is adopting new ways of working to increase representation in clinical trials. Speaker: Amanda Bishop, Associate Director, Clinical Trial Diversity Program Lead (DPL), Merck
Do you have patients interested in enrolling in a clinical trial but are unable to for various reasons? Perhaps they live in a remote area of the world, travel for work, or are a snowbird. Maybe it is physically demanding for them to travel to the clinic for visits, or it is challenging to make it to the clinic during business hours. During this session, we will discuss how home health can boost patient retention and recruitment and enable patient participation. Speaker: Nikki Skirvin, BA, CCRC, ACRP-PM, Director, Clinical Operations, Firma Clinical Research
In the pandemic world, the remote visit is becoming a standard visit type. Site and monitoring staff need to work together to ensure that all the remote platforms: medical records, pharmacy and regulatory are available as planned for the visit. The complex of systems, security measures, versions all need to work in harmony for a productive visit. A review and discussion about suggestions for pre-checks: visit composition, IT set-up and groupthink. The importance of scheduling (how early is too early), how to troubleshoot, who would be best contact for each platform, how to communicate expectations and document outcomes and issues. Speaker: Heidi Kirkpatrick, Sr CRA, Merck
The objective of this presentation is to discuss the top five budget items a site must include in every budget negotiation to be financially successful. Budget negotiation doesn’t have to be scary or intimidating as long as you stick to the essential items that help keep the site reimbursed for those pesky tasks that are not always related to direct patient care. Speaker: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford Hospital
The objective of this presentation is to identify which clinical research professionals sites should have on their team to strengthen their business. Once you have hired a clinical research coordinator, this session will identify the top five essential positions to hire at a clinical research site. We will discuss the functions performed by each role along with justifications to upper management for hiring these vital positions. Speaker: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford Hospital
The self-selection study will be introduced and discussed with the audience. A link to the current 2013 FDA guidance will be provided and discussion will touch on ongoing regulatory changes for non-prescription drug, dietary supplement and new dietary ingredient research. Even if you are not running a clinical trial on these topics today, this era of personalized medicine will touch many of our patients and the speaker wants to know how these regulatory changes affect your work. Speaker: Joy Frestedt, PhD, CPI, RAC, FRAPS, Frestedt Incorporated
I’d like to share my experience as a study coordinator who has also been a clinical trials subject. I believe this is a unique perspective that has allowed me to grow in my role in clinical trials. Coordinators and the research community can gain insight from my story and it will promote the importance of understanding our subjects in clinical trials. Speaker: Katharine Russman, CCRC, Clinical Research Project Coordinator, University of Colorado
There are so many reasons why sites use their own software for source data collection, regulatory document management and storage, and other critical processes. While site-owned technology has become more commonplace, Sponsors and CROs are not building solutions to support the transfer of data from sites into Sponsor/CRO systems (i.e., EDC, eTMF). The old-fashioned approach of pushing various technology down to sites is creating massive challenges for researchers and patients, and ultimately causing clinical research to be more costly and inefficient. While we all agree that inter-system data sharing is an end-all-solution to streamline our industry, how do we get meaningful buy-in from the top to finally realize this opportunity? Speakers: Rick Greenfield, BBA-IS, Founder & President, RealTime Software Solutions; Nathan Levens, Vice President of Site Solutions, RealTime Software Solutions. Sponsored by RealTime Software Solutions. This session does NOT offer ACRP Contact Hours.
Your site can be inspected by the Food and Drug Administration (FDA) at any time. Preparation is critical to an efficient, productive inspection. Find out about the agency’s expectations and how a proactive framework can help your site avoid burdensome follow-up and the dreaded Form FDA 483. Speaker: James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra. Sponsored by Advarra. This session does NOT offer ACRP Contact Hours.
Using the same old traditional methods for candidate recruitment could be a key reason for poor enrollment performance. Relying solely on external marketing campaigns, manual searches through EMR records, and practice referrals during patient appointments are a thing of the past. We all know that these approaches typically yield high screen fail rates, staff bandwidth issues, and extended trial durations. Transforming your operations to leverage practice partnerships, EMR connectivity, and advanced technology solutions prove time and time again to relieve the challenges of recruiting qualified candidates in an expeditious manner. Join us to learn how you can quickly become a top performer in your studies! Speaker: Walter Storm, Co-Founder and Chief Executive Officer, Aspen Insights. Sponsored by Aspen Insights. This session does NOT offer ACRP Contact Hours.
At ACRP 2022, we shared plans and progress regarding a new consortium of sites, sponsors, CROs, and data standards organizations. This group is aligned with Advarra’s strategic mission of solving a longstanding industry problem: securely and seamlessly sharing data and documents among research stakeholders to accelerate startup, improve communication, and bring treatments to market faster. In this session, hear an update on the Site-Sponsor Consortium and how their insight has shaped new technology and process. The speaker will share updates on the site eISF to sponsor eTMF document exchange, highlight how Advarra is working with customers and the Consortium to address broader communication and startup challenges for all stakeholders, and provide a glimpse at what challenges Advarra is planning to address next. Attendees will learn how sites, sponsors, and CROs are addressing these longstanding challenges, and will come away with actionable insight on steps they can take to take advantage of the progress that has been made. Speaker: Kate Yawman, Director, Project Management, Advarra. Sponsored by Advarra. This session does NOT offer ACRP Contact Hours.
Over the past several years, there has been an explosion in the volume of technology used to support clinical trials. While this has facilitated the ability to handle greater complexity and specificity within trials, much of this technology has also been developed in silos to solve for individual pain points, at times losing sight of the bigger clinical trial picture. In this techXpo session, we’ll follow the journey of one sample clinical trial participant from discovering their eligibility for a trial through to completion of one of their first trial visits. Along the way, you’ll learn about the Flatiron technology making the journey smooth and connected, not only for the participant, but also for site research teams and sponsors. Interested to learn more about how Flatiron is bridging the gap between care and research in advance of this session? Check out the piece, “Laying the Foundation for Integrated Evidence” co-authored by Lauren Sutton, MBA, Senior Director of Clinical Research Product Management and speaker of this session, and Neal Meropol, MD, VP or Research Oncology and Scientific and Clinical Lead of Clinical Research. Speaker: Lauren Sutton, MBA, Senior Director of Clinical Research Product Management, Flatiron Health. Sponsored by Flatiron Health. This session does NOT offer ACRP Contact Hours.