Category: Professional Development

Creating a Professional Workplace

Picture of Barbara van der Schalie, senior clinical research training manager and clinical monitoring research program directorate for Frederick National Laboratory for Cancer Research.

Barbara van der Schalie, MA

Senior Clinical Research Training Manager

Clinical Monitoring Research Program Directorate

Frederick National Laboratory for Cancer Research

Abstract: Professionalism is a key component of a dynamic, thriving workplace and a defining element of a productive workplace culture. As clinical research becomes more generationally diverse, professionalism standards are becoming less consistent. This article describes the changing concepts of professionalism, how it is judged, and how to optimize professionalism to benefit individuals and organizations.

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Workforce Development Transformation and Implementation: The Critical Role of Leaders in Success

Picture of Erika Stevens, faculty lecturer at Rutgers Clinical Research Management and Principal of Recherche Transformation Rapide. LLC

Erika Stevens, MA, FACRP

Faculty Lecturer

Rutgers Clinical Research Management

Principal

Recherche Transformation Rapide LLC

Picture of Liz Wool, President of Wool Consulting Group, Inc.

Liz Wool, FACRP, CCRA, CID, CMT

President

Wool Consulting Group, Inc.

Abstract: The role of leaders in successful implementation of a workforce development program is often overlooked. Notably, change management and the leader’s fluency in implementing change is necessary for success. This article describes the critical attributes for leaders to be able to manage and implement workforce development for their organizations, and for leveraging transformation management principles and practices for success.

Disclosure: The authors have no relevant financial relationship(s) in connection with this article.

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Cultivating an Effective Research Team Through Application of Team Science Principles

Shirley L.T. Helm, MS, CCRP Senior Administrator for Network Capacity & Workforce Strategies

C. Kenneth & Dianne Wright Center for Clinical and Translational Research

Virginia Commonwealth University

Abstract: The practice of team science allows clinical research professionals to draw from theory-driven principles to build an effective and efficient research team. Inherent in these principles are recognizing team member differences and welcoming diversity in an effort to integrate knowledge to solve complex problems. This article describes the basics of team science and how it can be applied to creating a highly-productive research team across the study continuum, including research administrators, budget developers, investigators, and research coordinators. The development of mutual trust, a shared vision, and open communication are crucial elements of a successful research team and research project. A case study illustrates the team science approach.

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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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How to Motivate and Retain Clinical Research Staff

Takisha Adair, Clinical Operations Manager, Covance

Abstract: Retaining staff is challenging for clinical research organizations. Motivating employees and engagement can help reduce staff turnover. Organizational leaders who desire to retain a talented workforce should tap into employee motivations and identify ways to incorporate these, where applicable, in employee retention efforts. This article highlights the key elements to motivate and engage research staff, especially millennials. Strategies that have worked well are highlighted from leading generational and change management experts.

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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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Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

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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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