Clinical research staffing demands ebb and flow during the protocol and subject management lifecycle. In this session, Jaylene Weigel (Senior Director of Clinical Research Management and Support, Children’s Mercy Hospital) and Emily Traw (Consulting Manager, Huron) will discuss their experience validating the need for a centralized clinical research professionals support model, review essential elements of the model design process, provide an overview of benefits and drawbacks of the model and rationale for use at Children’s Mercy, and lessons learned during implementation. This session is appropriate for all levels of attendees, but particularly those in leadership roles. Attendees will walk away with an understanding of the processes and tools used as this site identified and designed their staffing model.

CEU: 1.00 ACRP

Speakers:

• Emily Traw, Consulting Manager, Huron Consulting Group

• Jaylene Weigel, Senior Director of Clinical Research Support and Management, Clinical Trials Office, Children's Mercy Hospital

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Most federally funded, multisite studies already require oversight by a single institutional review board (sIRB), and soon that likely will be true for U.S. Food and Drug Administration-regulated studies. It’s no secret that sIRB review presents challenges for study teams, especially those managing investigator-initiated studies. This session will help you understand your responsibilities related to sIRB review and point you to resources you can take advantage of.

CEU: 1.00 ACRP

Speakers:

• Polly Goodman, Associate Director of Regulatory Affairs Operations, SMART IRB, Harvard Catalyst | The Harvard Clinical and Translational Science Center

• Michael Linke, PhD, Adjunct Professor/Director of Education, University of Cincinnati/SMART IRB

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Clinical research regulations, guidances, and advisories that come in an unending stream from the U.S. Food and Drug Administration are a fact of life that no one in the professional can afford to ignore. This session provides a high-level overview of recent and emerging regulatory issues in the conduct of clinical trials and other kinds of research in the United States.

CEU: 1.00 ACRP

Speaker:

David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare

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If you were inspired by the Signature Series presentation “We’re On This Journey Together,” want to hear more about the panelists’ initiatives, and are keen to ask questions of them, this is the session for you. If you are also interested in sharing what you, your team, and your organization have learned from your own clinical research outreach and improvement initiatives in a lively setting, here’s your chance to spread the word. This follow-up session to Monday morning’s gathering continues the conversation started there, and allows audience members the opportunity to ask questions and share the best practices they have cultivated for promoting excellence in and awareness of clinical trials in their workplaces and communities.

Speakers:

• Rick Fisher, Senior Vice President, Operations, Velocity Clinical Research

• Erin Stackowitz, US Innovation Lead, Clinical Study Unit, Sanofi

• Nancy Sacco, PhD, VP Head of Clinical and Site Development Operations, SiteBridge Research Inc (Moderator)

This interactive presentation provides an in-depth look at, and tools and resources for, protocol development with the goal of aligning the principles set forth in the U.S. Food and Drug Administration's draft guidance on diversity, equity, and inclusion (DEI) with the application of methods for decentralized clinical trials (DCTs) in the field.

CEU: 2.00 ACRP

Speaker:

Nadina Jose, MD, Assistant Professor, School of Health Professions, Rutgers, The State University of New Jersey

This panel discussion reviews the ethical, regulatory, and operational challenges of conducting Exemption from Informed Consent (EFIC) trials in cases involving life-saving, emergency treatments when obtaining consent is impossible.

CEU: 1.00 ACRP

Speakers:

• Kammy Jacobsen, PECARN Program Director, University of Utah, Data Coordinating Center

• Ann Johnson, MPH, IRB & HRPP Director, University of Utah, Institutional Review Board

• John VanBuren, PhD, Associate Professor, University of Utah

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This session will focus on building competencies, gaining stakeholder buy-in, and enhancing development in clinical research settings. Attendees will gain hands-on experience they can use to improve their companies and teams. With specific competencies being practiced by the right people, teams will see streamlined processes and eliminated or reduced non-essential tasks, leading to spending optimal time on revenue-generating activities. Furthermore, organization-specific competencies can facilitate better communication and increase the effectiveness of employee development.

CEU: 2.00 ACRP

Speakers:

• Mallory Frazier, MS, Manager of Learning and Development, Javara Inc.

• Lauren Fregonese, Senior Director of Learning and Development, Javara Research

• Michaela Mahin, Talent Management Specialist, Javara Inc.

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Concerned about capturing subject injury charges? Worried items and services have slipped out the door when Sponsor has agreed to pay? Unsure if all stakeholders have been alerted to a subject injury? Join us and hear about our journey in building a process to train all stakeholders and ensure billing compliance.

This presentation is geared to research billing compliance professionals, study coordinators, and site staff involved in operations and administration.

CEU: 1.00 ACRP

Speakers:

• Kevin Gardner, Jr., Director, Clinical Trials Office, Penn State College of Medicine

• Kimberly Perkins, Assistant Director, Clinical Trials Office, Penn State College of Medicine

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What if we could bring clinical trial opportunities right to where potential participants get their annual physical, their flu vaccine, and the majority of their care? Hear from an investigator and a leader from an integrated research organization as they discuss the challenges and how they overcame them to build a successful research partnership in a community-based primary care practice.

CEU: 1.00 ACRP

Speakers:

• Charlotte Grayson-Mathis, MD, Internal Medicine Specialist, First Georgia Physicians Group (Privia Health)

• Ashley Moultrie, CCRP, Director, DEI & Community Engagement, Javara

As regulatory expectations concerning greater diversity in clinical trials ramp up, a key change in focus for the clinical research enterprise becomes understanding the importance toward the patient experience of incorporating community outreach and engagement into site and sponsor operations. This session offers practical examples of tactics tied to diversity plans, community-based patient engagement, and clinical study recruitment efforts.

CEU: 2.00 ACRP

Speaker:

Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager, SiteBridge Research Inc

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Ongoing staff turnover challenges in the midst of burnout trends, talent poaching, career changes, and other trends can leave hiring and training officers feeling as if they are in the middle of a war to attract and retain talent. This session looks at staff retention strategies, best hiring practices, out-of-the-box recruiting strategies, and how to cultivate a culture of communication in order to build a functional and effective team.

CEU: 1.00 ACRP

Speaker:

Lauren Stockwell, Director of Outreach & Engagement, Clinical Research Fastrack

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Join us in the Marquis Ballroom for lunch while connecting with your fellow clinical research peers.

This session will share results from a survey of community health centers (CHCs) nationwide about their experiences, roadblocks, and needs related to supporting clinical studies. A CHC framework and toolkit will be provided so that study sites and sponsors will have the background needed to effectively approach CHCs for clinical trial collaboration.

CEU: 1.00 ACRP

Speakers:

• Ruma Bhagat, MD, MPH, Principal Portfolio Leader, Health Equity & Population Science, Product Development, Genentech

• Pete Fronte, MBA, President & CEO, Altura

• Sandy Orzel, Senior Director of Operations & Program Management, Neighborhood Healthcare

• Rakesh Patel, MD, MBA, FACHE, CEO, Neighborhood Health

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In a time when study coordinator burn-out can have dire add-on effects for entire study teams, this session presents a new role--the study manager--and the tools for making it an effective site-level solution to adjust to a radically changing world of sponsor expectations.

CEU: 1.00 ACRP

Speaker:

Jean Kelly, Associate Director of Clinical Operations, Rochester Clinical Research

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This session highlights the importance of a successful partnership between research operations and compliance, and will walk through lessons learned from cases of billing and research noncompliance that could only be resolved through effective collaboration and mutual support.

CEU: 1.00 ACRP

Speakers:

• Kate Cohen, JD, CHC, CHRC, Chief Compliance Officer, Southern Illinois University School of Medicine

• Amber Fifer, PharmD, ACRP-CP, Director of Operations, Center for Clinical Research, Southern Illinois University School of Medicine

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Rapid-Fire Sessions:

This part of the 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.

Mind the Gap: Achieving and Maintaining Effective Communication Between Sites and Sponsors
Speaker: Morgan Heck
This session presents a conversation outline for covering the many potential pain points that may arise in communications between clinical trial sites and sponsors who are new to one another, as well as long-term partners who nevertheless are experiencing ongoing miscommunication hassles.

Tools and Measurements for Driving Diversity and Inclusion in Clinical Trials
Speaker: Cameron Davis
This session examines how to identify resources and strategies for achieving operational excellence, improving access, and enhancing diverse and inclusive representation of patients in clinical trials.

Poster Sessions:

A 5–8-minute multimedia "poster presentation" given from the podium will feature a case study and real-life lessons learned around operational and process efficiencies in clinical research.

Evolving Training for and Satisfaction with Electronic Medical Record Systems
Speaker: Paula Smailes, DNP, RN, CCRP
This session addresses evolving clinical research training at one institution to ensure competency and increase the satisfaction of users of its electronic medical record (EMR) system, along with the value of an eLearning methodology to facilitate training.

Interpreting and Capitalizing on Research Participant Satisfaction Surveys
Speakers: Paula Smailes, DNP, RN, CCRP, Lisa Hafer, Deanna Golden-Kreutz, PhD, Holly Bookless, BSN, RN, NE-BC, Emily Brown
This poster focuses on how study sites can most effectively use research participant satisfaction surveys for collecting and benefiting from data on patient demographics, motivating factors for research participation, perceptions on the informed consent process, and questions pertaining to the research experience.

This presentation will detail the importance of transparency, positivity, and professionalism framing all aspects of the process for evaluating the performance of clinical research associates (CRAs) during study site monitoring visits. It will review best preparation and communication practices for visit execution that will elevate the evaluation beyond a simple "pass or fail" determination, leading to a better understanding of competent performance, training needs, and the value of trust between evaluators and CRAs.

CEU: 1.00 ACRP

Speaker:

Elizabeth Weeks-Rowe, LVN, CCRA, Independent Clinical Research Consultant, Elizabeth Weeks-Rowe Consulting, LLC

Related Blog Content:

Who Monitors the Monitors? CRA Evaluations Essential to Better Trials and Relationships

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This session delves into the transformative potential of critical thinking in clinical research, highlighting strategies that can help professionals quickly adapt and build a quality-driven approach as the industry undergoes rapid and continuous changes.

CEU: 1.00 ACRP

Speaker:

Matt Baublits, Associate Director, Country Clinical Quality Manager, Merck

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This session is tailored for anyone who wants to learn more about methods for, and the potential impacts of, designing and implementing research through a health equity lens, including tactics for effectively addressing disparities, fostering inclusivity, and enhancing participant engagement through culturally competent strategies.

CEU: 1.00 ACRP

Speaker:

Aimee Pehrson, MHA, MPH, CCRC, Researcher, The University of Tennessee and Prometheus Federal Services

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Attendees in this session will learn from case studies how to assess their organization’s current business strategy, develop a value proposition and competitive advantage, and utilize a structured method leading to a new organizational strategy that is best suited to their situation as a site, contract research organization (CRO), or other stakeholder in the clinical research enterprise.

CEU: 1.00 ACRP

Speaker:

Fraser Gibson, Project Manager, Fortrea

Explore how one institution implemented an informed consent training program through both didactic training and simulated consenting scenarios. Upon completion of this activity, learners will be able to implement similar programs at their home institutions. 

CEU: 1.00 ACRP

Speaker:

Kevin Gardner, Jr., Director, Clinical Trials Office, Penn State College of Medicine

Related Blog Content:

Simulated Informed Consent Training Can Lead to Real-World Improvements

A powerful element in study start-up and ongoing study implementation success is the study coordinator. Building a network for coordinators across sites that are conducting the same (or similar) protocols can prove to be the secret ingredient to success. This session will demonstrate the power of peer-to-peer communication, mentorship, and support in a research consortium.

CEU: 1.00 ACRP

Speakers:

Teri Crumb, Project Manager, PNRC Consortium

Margaret Kamel, PhD, Director of Research Projects, Emory University, Health Sciences Research Building

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As a workforce crisis continues to complicate goals for hiring staff with existing clinical research experience, one small contract research organization (CRO) addressed the issue by creating a successful clinical research associate (CRA) training program. This session offers actionable strategies for enhancing clinical research training programs and empowering teams, and lessons learned for fostering a culture of excellence and growth by setting high expectations and providing early guidance for self-sufficiency.

CEU: 1.00 ACRP

Speakers:

• Kathleen Kane, MBA, CCRP, Senior Manager, Clinical Operations, NMDP

• Alisha Mussetter, Manager, Clinical Monitoring Operations, NMDP

• Kassandra Nealon, BS, Clinical Research Associate II, NMDP

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This session is designed to help prepare first-time oncology trial team members to face the ins and outs of complex study designs, laboratory considerations, data gathering and management chores, adverse events reports, tumor response assessment, RECIST vs iRECIST issues, and more.

CEU: 1.00 ACRP

Speaker:

Heidi Kirkpatrick, Sr. Clinical Research Associate, Merck

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Be a communication champion and pave the way for successful clinical trials! Discover the transformative impact of effective communication on trial success. Learn practical strategies to conduct informed consent discussions, provide compassionate updates, and build participant trust. Uncover the secrets to boosting participant retention and satisfaction. PIs, CRCs, and CRAs will unlock clinical trial success through the power of communication. Equip yourself with a communication toolkit with patient education techniques, cultural considerations, and decentralized trial communication solutions. Prepare to excel in a digital era with active listening skills and ethical practices. Elevate your clinical trials with our comprehensive communication approach.

CEU: 1.00 ACRP

Speaker:

• Naomi Orebiyi, CEO and Founder, UnCharted Access

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Too often, individuals aspiring to become Clinical Research Associates (e.g., Study Coordinators) don’t have the required means to learn about this crucial role. Moreover, new CRAs are often sent into their earliest site monitoring visits with limited practical training or oversight, and with little appreciation for the best practices of veterans in the field. This hands-on workshop is designed to give practical tools and tips on conducting a monitoring visit, fill gaps in basic monitoring knowledge, give an opportunity to practice monitoring scenarios, and provide a judgement-free environment for asking the questions that new CRAs often hesitate to raise with their managers and Study Coordinators struggle to find answers for.

CEU: 2.00 ACRP

Speakers:

• Demi MacLennan, MS, CCRA, ACRP-PM, Sr. Project Manager, Fortrea

• Negar Roofigari, Clinical Trial Manager, Fortrea

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The histories of risk management, banking, library science, and mathematics are all deeply intertwined. This session considers how the tenets of risk management, also known as actuarial science, were first integrated into the clinical research Industry, eventually adopted internationally as part of the ICH E6(R2), and what to expect on the subject in the forthcoming ICH E6(R3) update.

CEU: 1.00 ACRP

Speaker:

Crystal Olson, Senior Clinical Project Manager, ProSciento

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There is an appreciable link between a would-be trial participant's financial situation and the levels of access and inclusivity in trials. This presentation examines some of the financial challenges to clinical trial participation, solutions and strategies that can be implemented to overcome those barriers, and other considerations for creating a more equitable healthcare system that leaves no patient behind.

CEU: 1.00 ACRP

Speakers:

• Michelle Chawla, Diversity Program Lead, Merck

• Adam Penna, Sr. Clinical Operations Manager, Associate Director, Clinical Operations, Merck

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There's no doubt that worker overload drives low morale and high turnover among staff--in clinical research settings no less than anywhere else. This session considers how trial site managers can be fair and equitable with their teams in terms of workload expectations. The development of a workload acuity tool can put measures in place to establish a consistent process leading to better hiring decisions and increased employee satisfaction, efficiency, and productivity.

CEU: 2.00 ACRP

Speakers:

• Christina Brennan, MD, MBA, Senior Vice President, Clinical Research, Northwell Health

• Richard Dima, MD, CCRC, Senior Director, Clinical Research, Northwell Health

• Virgenmina Lugaro, Director, Clinical Research, Northwell Health

• Kristine McGowan, DNP, Senior Director, Clinical Research, Northwell Health

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This session focuses on one organization's experience with developing its clinical project management workforce through interdepartmental cooperation and the incorporation of the Joint Task Force for Clinical Trial Competency's framework for job roles. Examples will be shared of the tools and diverse communication methods used to encourage better engagement and synthesis of information leading to a highly trained and agile clinical research team.

CEU: 1.00 ACRP

Speakers:

• Kim Bloom, MPA, CCRC, Clinical Research Project Manager, University of Utah, Department of Pediatrics, Division of Critical Care, Data Coordinating Center

• Heather Gramse, BS, CCRP, Program Director, University of Utah, Department of Pediatrics, Division of Critical Care, Data Coordinating Center

• Marie Kay, BA, PMP, LSSGB, CCRC, Program Director, University of Utah, Department of Pediatrics, Division of Critical Care, Data Coordinating Center

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