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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Clinical Research Nursing Conference– Understanding the role that nurses play in Clinical Research and Empowering them to become leaders in the field

Jennifer Goldfarb

MSN, RN, CCRP

Introduction

We here at SOCRA are very excited for the relaunch of the Clinical Research Nursing Conference which will be offered virtually this November. The course faculty includes very experienced clinical research nursing professionals who will be bringing a wealth of knowledge and experience to the conference attendees. Take a look below for our Course Chair’s personal perspectives on Clinical Research Nursing – how she became a nurse, then clinical research professional and why she’s not only excited for this course, but also where the field is headed. As you’ll see below – this is an exciting time. This conference presents the opportunity to highlight the role that nurses play in Clinical Research, to celebrate this role, and to empower them to become leaders in the field.

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An Inspiring Interview with SOCRA’s 2022 Recipient of the President’s Special Recognition Award for Distinguished Service: Nancy Wintering, MSW, LCSW, CCRP

From September 14 to September 17, 2022, our global clinical research community will gather virtually for SOCRA’s 31st Annual Conference to enjoy an engaging learning and networking experience to promote safe, efficient, and high-quality clinical research.

At the event, we will honor this year’s President’s Award recipient Nancy Wintering, MSW, LCSW, CCRP, for outstanding service and dedication to SOCRA’s mission. Nancy is the Assistant Director of Research for the Marcus Institute of Integrative Health at Thomas Jefferson University. Nancy has served SOCRA in many ways, including as a past board member, SOCRA Source Journal author, Annual Conference speaker and session chair, workshop and conference organizer and speaker, and poster presenter.

We caught up with Nancy to discuss her thoughts on clinical research, SOCRA, the future, and much more. Read on for interesting insights and perspectives in this inspiring interview.

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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

Incoming SOCRA Board Member

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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Clinical Trials Day 2022: Insights from SOCRA Nominee Aryn Knight

Aryn Knight, CCRP

Administrative Director

Texas Heart Institute

Houston, Texas

On May 20, the world will honor clinical research professionals in an annual celebration of Clinical Trials Day (CTD). This internationally recognized event raises awareness of clinical trials and the many career opportunities in this wonderfully rewarding field, and it is our honor to kick off the 2022 celebration. In keeping with tradition, we’ve invited SOCRA members to nominate each other for their outstanding work and contributions to public health, medical advancement, and improved health outcomes.

In this article, we’re sharing the insights and perspectives of Aryn Knight, Administrative Director for the Center for Clinical Research at Texas Heart Institute. We are recognizing Aryn for her positive contributions to clinical research education and advocacy.

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Clinicaltrials.gov Registration and Results Reporting for Investigator-initiated Trials

Kate Anderton, MPH, CCRP

Clinical Trial Lead Firststring Research Inc.

Abstract: Trial registration and results reporting is an important aspect of investigator-initiated trials. This article provides an overview of ClinicalTrials.gov, the purpose of clinical trial registration and results reporting, and how to register and report results for investigator-initiated trials. The new ClinicalTrials.gov requirements and the meaning of the changes are also covered.

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Revenue Optimization Clinical Trial Challenges

Headshot of Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP

Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP

Kelly Willenberg & Associates

Abstract: Data is a powerful tool that can be leveraged to drive key decisions for a health system. This article describes various data elements, metrics, and key performance indicators that aid a health system with making key decisions about its research portfolio. Using denials management is one example of leveraging the data to build a robust Coverage Analysis, increasing revenue for the health system. This article also provides information that can be used to develop staffing models and productivity models.

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Research Recruitment Study – MyChart Message Recruitment

Andrew Snyder MBA, PMP, FACMPE

One of the most common challenges of conducting clinical trials is related to problems with recruitment.   Insufficient or untimely patient recruitment for clinical trials may have serious consequences.   The length of the study may be extended, leading to increased costs and staffing concerns.   Trials that do not recruit the required number of patients may impact the data integrity.  Study teams that cannot recruit patients may not be invited to participate in future studies by industry partners or may have difficulty securing future grants.   In some cases, a trial may have to be terminated resulting in unpublishable results, poor financial outcomes, and disappointed stakeholders.

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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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