Clinical Trials Day 2024: A Call to Reflect, Engage & Inspire

Clinical Trials Day is a moving reminder of the clinical research community’s pivotal role in shaping the future of the field. It’s a day of reflection for us to thank you and also a call to action, urging us to actively engage in advancing clinical research to drive innovation, improve patient outcomes, and enhance healthcare.

In this article, we’ll reflect on the successes of our SOCRA Chapter Volunteers to demonstrate the vast possibilities we can uncover together. For those who feel inspired to take action, chapter volunteers will share valuable tips for starting a local SOCRA chapter. These chapters empower local clinical research communities and provide a platform for personal growth and career development, enabling you to make a difference while fueling your professional aspirations.

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Leadership and Line Management in Clinical Research

Anatoly Gorkun
Senior Manager, Global Clinical Management, PPD
Hugh Devine
Senior Director, Global Clinical Management, PPD

Abstract: Line management is generic, utilizing the same approaches throughout all industries; line management brings together company needs and its workforce to deliver company objectives. This article provides an overview of line management styles and line-management-through-leadership approaches in the clinical research environment. The line management cycle – team building, support, motivation, and development—is described. Real-life examples illustrate how line management can support clinical research deliverables.

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Career Progression in Clinical Research: Transitioning from a Clinical Research Coordinator to a Monitoring Clinical Research Associate (CRA)

Thomas Boothby, MS, CCRP CRA II, Boston Scientific

Abstract: Research coordinators may transition to clinical research associates/monitors during their careers. This article provides an overview of how to determine whether it is the right time to make this transition, how to evaluate current competencies and gaps that must be filled in order to make this transition, and how to address needs during the on-boarding process. A roadmap in the form of a checklist is provided to help make the transition from research coordinator to clinical research associate (CRA) a smooth one.

Disclosure: The author has a relevant financial relationship with respect to this article with Boston Scientific, where he is employed as a monitoring CRA.

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Understanding Research Wrongdoing: Lessons from the Professionalism & Integrity in Research Program and the Bioethics Research Center

Headshot of James M DuBois, DSC, PhD from the Professionalism & Integrity in Research Program.

James M. DuBois, DSC, PhD, Director, PI Program and Bioethics Research Center, Washington University School of Medicine

Abstract: Many factors increase the risk of research integrity violations or serious non-compliance. This article explores these factors, highlighting wrongdoing and “right-doing” in research, using data from the first 68 participants in the Professionalism & Integrity in Research Program and the Bioethics Research Center at Washington University School of Medicine. The Professionalism & Integrity in Research Program serves investigators following professional lapses. The Bioethics Research Center studies the factors that contribute to violations of research integrity and also to exemplary research. The implications of these findings for remediation and prevention of research integrity violations are described.

Disclosures: The author has no financial conflicts of interest. He is the director of the Professionalism & Integrity in Research Program. Projects described in this article were funded by NIH CTSA, R01, K01, R21, ORI RRI Program, and CITI sponsorship from 2014-2016.

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Introducing Generation Z: Who Are They and How Will They Impact the Clinical Research Workplace?

Barbara van der Schalie, MS
Learning and Professional Development Manager  
Clinical Monitoring Research Program Directorate
Frederick National Laboratory for Cancer Research, Sponsored by the National Cancer Institute

Abstract: Generation Z, the postmillennials, are the latest addition to the extremely generationally-diverse American clinical research workplace. Their preferences for critical workplace parameters, including workplace engagement, communication, leadership approaches, and flexibility, differentiate them from even their most closely age-aligned colleagues, the millennials. This article describes the differences between and preferences of the generation and provides ways to optimize the integration of Generation Z into the current clinical research workplace.

Disclaimer: This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

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Influencing Without Authority

Barbara van der Schalie, MS
Learning and Professional Development Manager
Clinical Research Directorate, Clinical Monitoring Research Program
Leidos Biomedical Research

Abstract: Effectively exercising influence, even when one may not have the formal authority to mandate action, is a challenge many clinical research professionals face in their daily work. This article describes the interpersonal and leadership skills necessary to ensure that one’s agenda is not only considered but actively requested, and how successful professionals build networks of relationships with stakeholders and influencers. This article explains the difference between influence and authority, identifies different sources of influence, and describes different influencing styles.

Disclaimers:

  • This project has been funded in whole or in part with federal funds from the National Institutes of Health’s National Cancer Institute, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercials products, or organizations imply endorsement by the United States government.

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