The Association of Clinical Research Professionals

Virtual ACRP 2020, Part II – Full Program Replay

This package is a replay of the ACRP 2020 Virtual, Part II Program.  It includes the following sessions:

  • Women in Leadership: Chutes, Ladders, and Unexpected Journeys

What does it really take for women to succeed at the highest levels of clinical research? Hear executive leaders get “real” about their career journeys—all the failures, successes, mentors, sponsors, and twists and turns along the way. Join our esteemed panel for an honest conversation about what it takes to advance as a woman in research. Speakers: Patricia Leuchten, Founder and CEO, The Avoca Group; Jeanne Hecht, MBA, PMP, Chief Executive Officer, Ora, Inc.; Jennifer Byrne, CEO, Javara Research; Corsee Sanders, PhD, Board Director and Strategic Consultant, Juno Therapeutics; Katherine Vandebelt, Global Head of Clinical Innovation, Oracle Health Sciences Global Business Unit

  • Choosing Courage over Comfort: Daring Leadership for High-Functioning Clinical Research Teams

This session is designed to improve the leadership skills of attendees and increase their competency in the Leadership and Professionalism domain. Attendees will be able to describe the skill sets of daring leadership and apply them into their daily work. What the clinical research world needs now more than ever are brave leaders. Current research by Brene Brown reveals that the key to brave leaders is courage and the only way to get to courage is learning to rumble with vulnerability. Speakers: Lynn Bartholow, CCRC, Executive Director of Research Compliance, Avera Health; Melissa Hiatt, President, Levav Leadership Consulting

  • Advancing the Clinical Research Workforce through Effective Internships

When you ask a group of clinical research professionals how they got into the industry, it is not surprising to hear, “I fell into it”. As the spotlight focuses on advancing professionalism of the clinical trial workforce, the need for earlier development pathways for future clinical researchers is obvious. If you are interested in building an intern program, attend this session to learn how to identify the best student interns, determine if they will be a good fit, provide them with the training necessary to develop their qualifications, and decide how and when to take the next steps. Speakers: Bridget Browder, MS, CCRC, Manager, Learning and Development, MedTrials; Amber Beckham, MS, ACRP-CP, Clinical Research Associate, MedTrials; Deepti Patki, MS, CCRC, Study Start-Up Specialist, Hoffman-La Roche, Canada

  • Stop Measuring Seat Time – An Introduction to Competency-Based Learning in Clinical Environments

Training has long focused solely on gaining certain knowledge or skills. However, neither skill acquisition nor successful implementation is tracked. Instead, training records show merely whether or not an employee participated in a training, when, and how long it took them. By changing our focus from measuring how much training someone attended (seat time), to examining what they can do as a result of their learning or training, we can create a culture of learning that is about helping organizations make real change. This highly-interactive session will focus on the what, why, and how of developing competency-based learning and give participants the opportunity to begin planning CBL experiences for their staff or clients. It’s so much more than quantifying the amount of training, it’s time to measure its impact. Speakers: Dr. Philip Holmes, EdD, Senior Director of Organizational Development, Rho, Inc.; Greg Garner, MEd, Learning and Performance Specialist, Rho, Inc.

  • Square Peg in a Round Hole: Remote Trial Innovation During a Pandemic

Learn how one CRO created a compliant trial design amidst a pandemic and continuously updated guidance. The session will provide insight for all clinical research professionals on a truly remarkable circumstance and never seen before timelines that may transform the future of trial design. Speaker: Jessica Thurmond, ACRP-CP, Clinical Trials Manager, Clinipace

  • Welcoming Technology into the World of Clinical Trials

100% virtual, or “site-less’, trials are entering the clinical research marketplace. Is the site community aware? Site sustainability hinges on sites’ awareness of this movement and their commitment to growing with the future of clinical research. This session will provide site staff with a high-level overview of what 100% virtual trials are, outline the difference between “site-less” trials and virtual or hybrid trials, and identify tools that sites can utilize when promoting their organization as the better, more desirable alternative. Attendees will be equipped with the knowledge and solutions needed to remain a strong, forward-thinking and sustainable site. Speakers: Amanda Rangel, MS, CCRC, VP of Business Development, VirTrial; Kim Kundert, RN, BSN, VP of Operations, VirTrial

  • Hang Ten: How to Surf the Wave of New Technology Without Wiping Out

Conducting clinical trials is a lot of work and sponsors, sites, and CROs are constantly looking to identify new technology solutions (e.g. EHR, CTMS, eTMF, ePRO) that can help run more efficient clinical trials (e.g. patient identification, collection of data, timelines for study completion, operational improvements) . Identifying and implementing new technology can be a daunting task, with how to approach the process, cost implications, unexpected delays, and change management risks to user acceptance. In this session, we will tackle tips for identifying the right technology to solve your problem, configuration to meet your needs, user implementation, and evaluation to ensure the technology continues to support your clinical trial. We’ll provide you with a toolkit for technology rollout success. Speakers: Rachel Berry, RN, MSN, Senior Director, Operations, Rho; Nick Poulson, PhD, Project Lead, Rho; Katharine York, BS, Senior Clinical Systems Analyst, Rho

  • A Plain English Description of Emerging Technology and How It May Contribute To Research

New technology is being introduced to clinical research operations so rapidly that it seems like a daily occurrence. At the same time, the roles of clinical researchers are changing as these tools are put into place. Some simplifying the workload, others seemingly making it more complex. This session will look at these trends and use a “crystal ball” to tell us the expectations of clinical researchers in the future. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity HCA Healthcare

  • Patients First: Building Compassion in Research

Join us for a candid discussion as a clinical researcher, patient and physician share their unique stories of learning compassion for clinical research patients in very unexpected ways. At times, the role of the patient in clinical research can get lost in the day to day tasks of a trial. Learn how clinicians can build compassion into their work and bring more awareness to clinical research and opportunities that exist for patients. Speakers: Jennifer Byrne, CEO, Javara Inc.; Dr. David Zaas, MD, MBA, Chief Executive Officer for the Charleston Division and the Chief Clinical Officer for MUSC Health, Medical University of South Carolina; T.J. Sharpe, Patient Advisor, Starfish Harbor

  • Improving Alignment and Risk Management Approaches Across Pharma/CRO/Site Relations

This session will focus on skillsets and approaches when working to establish alignment and improve outcomes across stakeholders- Pharma, CRO and Site Relations. We will actively analyze common challenges with particular focus on risk assessments, root cause analysis, problem-solving and escalation/communication facing us in 2020 and beyond. Speakers: Amanda Wright, BS, Vice President of Partnership Development, Javara Research; Lynn King, BA, MHA, Executive Director, Clinical Management, North America Regional Head, PPD

  • Secrets to Site Operations Success

    “Are we there yet?”  How many times did you say this as a child, or hear it as a parent?  When it comes to the time and energy needed to get a study up and running, the research path sometimes feels similarly long, grueling and tiresome.  For this presentation, you will peek behind the scenes at study expectations from sponsor and site perspectives.  You will learn what one community site does to review potential studies, assess each for feasibility, and how these processes are driving institutional changes necessary to fit shifting protocol demands.  We will help you identify ways to improve site performance and manage the cries of “are we there yet?” Speakers: Evonne Lackey, BA, CCRP, Director of Clinical Research, Swedish Cancer Institute; Erik Bailey, CCRP, Oncology Research Coordinator Lead, Swedish Health Services

  • Integrating Quality into Investigator-Initiated Trials

There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial, but may be overlooked in Investigator-Initiated Trials (IITs) leading to IITs that are poorly designed, over budget, and difficult to analyze. This session will describe how to apply quality principles to investigator-initiated clinical trials utilizing tips, tools, and templates available to help along the way. Speaker: Neala Lane, MS, CCRC, Associate Director, Quality Improvement Office Indiana University

  • Creating a Training Pathway for Your New Investigator

A challenge facing new study investigators is how to learn all elements of the investigator role, in addition to research regulations, to understand/successfully complete investigator responsibilities. A strategic learning process will ensure understanding of such critical items as investigator oversight, staff education/certification, appropriate delegation, clinical research vs. practice, staff management, protocol review, administration/business development, and effective communication, etc. This presentation focuses on fundamental steps to take to best prepare a physician for their new role as PI/Sub I in independent practice, or as part of a research site network. It will provide examples of best practices employed by successful sites in selecting/training new physician investigators and showcasing capabilities with finesse during site selection. It provides a training pathway that new investigators can follow to successful study conduct and strategic relationships. Speaker: Elizabeth Weeks-Rowe, LVN, CCRA, Clinical Research Trainer/Writer, Clinical Research Writing and Training

  • Feeling All Alone: Building Community Among Coordinators in a Consortium or Within a Large Center

Communication and teamwork are critical skills for coordinators of experience level or any size institution. This session will address how to develop community from both the perspective of consortium research studies as well as large academic centers. The session will provide the audience with an overview of consortium research and why coordinators feel alone and unsupported. Additionally, the same can be true in a large academic center where staff are often working in department silos. We will identify key ways to develop community, even in low budget settings. We will provide evidence as to why mentoring relationships are not only beneficial, but they serve to advance the profession of clinical research coordinators. The session will include a panel discussion where audience members can ask questions and dialogue together. Speakers: Teri Crumb, MSN, RN, CCRC, Pediatric Clinical Research Nurse II, Spectrum Health/Helen DeVos Children’s Hospital; Corinna Bowers, BSBA, CCRC, Senior Clinical Research Program Manager, Nationwide Children’s Hospital; Margret Kamel, PhD, CHES, CCRC, Associate Director of Research Projects, Emory University; Theresa Kump, BA, CCRP, Clinical Research Manager, Medical College of Wisconsin

  • Conflict & Communication Competence in Clinical Research Project Management

Project management is a hot topic applied to clinical research. The Clinical Research Professionals who manage projects must ensure research is efficient, quality and safe. Compromised understanding and lack of high-level communication skills can delay protocol approvals, confound logistical planning, corrupt data integrity and threaten participant safety. In the light of ACRP’s alignment with the JTF Competencies Framework, it is important to note professional competence is in part defined by the habitual and judicious use of communication in daily practice for the benefit of those being served. Communication and teamwork require the capability to communicate competently in challenging interfaces as a core skill to sustain trust and efficiency. We will offer guidance to improve competent communication in clinical research teams. Speakers: Jade Williams, PhD, Faculty, University of Florida; Robert Kolb RN, MS, CCRC, Assistant Director Clinical Research, University of Florida

  • A Competency-Based Job Classification Tool – The ‘Title Picker’ Implementation Across Two AMCs

Duke updated and aligned the job classifications for research professionals at our institution through the utilization of the Joint Taskforce for Clinical Trial Competency framework. We created a tool that would blend consistency among our existing incumbents and new hires. We created a REDCap tool for incumbent mapping of 700+ clinical research professionals. The tool was modified to classify 353 new hires into competency-based positions and 187 internal position changes (reclass, transfers). We will demonstrate how this tool was adapted and implemented at The University of Alabama at Birmingham to align clinical research job classifications within a competency-based framework for existing positions through the implementation of the Clinical Research Career Ladder initiative with plans to continue to expound on this by modifying the process for new hires in the future. Speakers: Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine; Christine Deeter, Project Planner, Duke University School of Medicine; Mark Marchant, MBA, MPH, Director, Clinical Trial Administrative Office, The University of Alabama at Birmingham

  • Shades of Gray: Navigating Ethics in Every Day Research

Research coordinators regularly face questions involving “everyday ethics” – scenarios that arise in the course of work that cause one to pause. Is it okay to continue with enrollment? Do I need to involve the PI? Is this a question for the IRB or a research ethics consultant? We will present real case scenarios and employ group discussions to examine these ethical questions within the context of the research setting. Attendees will be encouraged to share everyday ethics issues they have encountered in their own work. After focusing on everyday ethics, we will present eight benchmarks that are used to evaluate the ethical nature of research. We will conclude with the presentation of a case that goes beyond every day ethics and use the benchmarks to guide our discussion. Speakers: Mike Donahue, BS, Research Coordinator & Manager, Data and Safety Monitoring Program, Clinical Trials Office/University of Washington Medicine; Stephanie Kraft, JD, Assistant Professor, Seattle Children’s Research Institute; Kathryn Porter, JD, MPH, Research Scientist, Seattle Children’s Research Institute

  • To Peer or Not to Peer Review, That is the Question: Peer Review as a Quality Assurance Tool for Site Monitoring Visit Reports

Peer review is defined as the scrutiny and evaluation of a person’s work by one or more people within the same discipline and with similar expertise. It functions as a form of self-regulation by qualified members of a profession within their field. The peer review process is thought to assure accuracy, provide credibility, support and maintain integrity and authenticity in writing in addition to encouraging writers to produce high-quality documents. The site monitoring visit report (SMVR) is an essential document in clinical research with far-reaching impact that could benefit from the peer review process. Peer review can also help CRAs improve their writing skills. This session will explore the peer review process, benefits and drawbacks, how it can be implemented for SMVRs and present CRA feedback on its use. Speakers: Roslyn Hennessey, PA, MS Project Manager, Westat; Bert Arevalo, BS, CCRP, Senior Clinical Research Associate, Westat

  • No Participants, No Trial (Don’t Plan for Everything, but Recruitment)

Meeting recruitment goals and timelines is a consistent challenge, and the responsibility typically falls to the research coordinator. Research coordinators are often asked to develop recruitment plans and materials with a limited budget and limited creative backgrounds. This session will provide practical guidance and tips to characterize the study population and their needs, track and measure recruitment strategy success, and create eye-catching recruitment materials to develop an effective recruitment strategy. Speakers: Charles Gregor, MPH, Trial Innovation Network Coordinator, University of Washington; Mike Donahue, BS, Research Coordinator & Manager, Data and Safety Monitoring Program, Clinical Trials Office/University of Washington Medicine

  • Social Media and Participant Recruitment: What We’ve Learned So Far

Researchers are increasingly using Facebook to recruit prospective participants in research studies. Due to the limited guidelines and regulations regarding the use of social media, institutions and sponsors struggle with the timely and effective evaluation of social media protocols. To harness the potential of social media and to ethically and effectively recruit participants into research studies, there is a need for evidence-based best practices for using social media as a recruitment strategy. We will discuss our stakeholder-informed process as a case study to demonstrate how we established social media guidelines and how we evaluate the effectiveness of using Facebook to recruit research participants. Practically, institutions and sponsors can model our process to develop, implement, and evaluate procedures for using social media as a strategy for recruitment.  Speaker: Elizabeth Flood-Grady, Ph.D., Postdoctoral Associate, STEM Translational Communication Center, Clinical Translational Science Institute, University of Florida

  • Development of an Institutional Research Education Program: Addressing Research Professional Needs

Providing research education and training at an institutional level has the potential to assist in standardizing on-boarding and research conduct, while providing opportunity for continuing professional development for research professionals. This presentation describes the process of building an institutional research education program based on data from a needs assessment conducted within the institutional research community, and a subsequent evaluation and follow-up needs assessment to determine future program development. We will discuss how education gaps can be identified and addressed to assist research professionals in conducting high quality, compliant research. Speakers: Erin Lynch, Clinical Research Educator, Lurie Children’s Hospital Office of Research Integrity and Compliance ; Michelle Corbett, MS, Assistant Director, Clinical Research Education, Lurie Children’s Hospital Office of Research Integrity and Compliance

  • The Plight of the CRA: Tips and Tricks for Mastering Your Craft

This session will provide you with techniques to help advance you in your CRA position. Whether you are looking for advancement in your career or professional development skills to succeed this is the session for you. While the content focuses on developing the expertise of the monitor, this course also benefits sponsor/CRO personnel involved in project planning and management, as well as site staff who are involved in data entry. Speaker: Reginald Hooks, MS, MPH, PMP, Associate Director, Clinical Operations, Oncolytics Biotech

  • Developing the Next Generation of Clinical Research Professionals in Biotech Companies

In the rapid growth of the biotech world, the clinical jobs are different, and there is increasing need to hire the right people now, as we develop the next generation of clinical research professionals. When unqualified clinical staff manage studies and vendors there is direct impact in cost, time and quality. Given that there are close to 100 programs in the United States from online certificates to Masters programs in Clinical Research Management, there are wealth of interested candidates to draw from. So, what’s missing? A group in Boston created a “Bridge to Biotech” program to provide practice and improve application of theory, creating a more skilled and experienced workforce to populate the next generation of clinical operations. Learn more about the effort to expand the initiative beyond New England. Speakers: Manny Lazaro, MS, Vice President, Head of Clinical Operations, Jounce Therapeutics; Laurie Halloran, BSN, MS, CCRA, President & CEO, Halloran Consulting Group

  • Identifying, Qualifying and Retaining Investigators

The investigator turnover rate is high, the “one and done” phenomenon is real in the clinical trials industry. What seems to be the root cause? Are we demanding too much from our PIs? Is it the complex protocol design? Learn how to identify investigators, train them and all the while keep them engaged. Speaker: Christina Brennan, MD, MBA, CCRC, VP, Clinical Research, Northwell Health

Purchase Full Program Replay

This program is a compilation of recorded sessions from Virtual ACRP 2020, Part II.