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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Partnering with Patients to Accelerate Cancer Research: Count Me In

Sara Balch, author

Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard

Abstract: Count Me In is a research initiative whose aim is to engage patients living with all major cancer types, as well as those with rare cancers. Along with this goal, Count Me In hopes to bring about a cultural shift that empowers patients, researchers, and clinicians to work in partnership and accelerate medical progress by allowing  researchers to work directly with patients and advocacy groups along with software engineers and computational scientists, to collect, analyze, and share de-identified data. The combined power of thousands of individual experiences will assist researchers in understanding, why patients respond differently to treatments, uncover new genetic targets for therapies, and help propel groundbreaking discoveries that transform cancer care.

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Conducting Clinical Trials in Canada Inspections of Clinical Investigators

Clinical Investigator Inspections

Mike M. Rashti President, BIMO Auditor and Trainer, LLC

Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to prepare for an inspection and differences between inspections of clinical research sites in the United States and Canada are discussed. Protocol violations observed at Canadian sites that have been documented by FDA Form 483s (Inspectional Findings) and Warning Letters are noted in this article.

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Clinical Trials Day 2021: A Time for Celebration and Reflection

May 20th  marks Clinical Trials Day (CTD), an international commemoration of James Lind’s launch of the scurvy clinical trial on May 20, 1747, which would form the foundation for modern clinical research. Celebrated for the first time in 2005, CTD raises clinical trial awareness and honors clinical research professionals across the globe. In celebration of this distinguished occasion, we’ve continued our three-year tradition of inviting SOCRA Members to nominate each other for their outstanding work and contributions to public health, medical advancement, and improved health outcomes. We caught up with our first 2021 nominee to uncover her thoughts and insights on the significance of CTD and the clinical research industry as a whole.

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Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

Michael Mapel, CCRP
Clinical Research Lead
UCLA Pediatrics Office of Finance & Research Children’s Discovery & Innovation Institute1

Abstract: Activating a clinical research project at an academic medical center requires significant planning and effort from study teams. Research sponsors often have difficulty understanding any process lacking in consistency and transparency and so start-up becomes a barrier to study enrollment. This article breaks down such barriers by advocating specific project management and communication tools and techniques that accelerate the study start-up process without sacrificing quality.

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Using Workflow Mapping to Improve the Recruitment Process in Clinical Trials

(Originally presented abstract at 2019 Annual Conference San Antonio)
Sara Sampaio MD, CCRP,*, Sepideh Saroukhani MD, MS, PhD candidate, Aryn Knight BS, CCRP, Jennifer L. Chambers RN, BSN, CCRC,
Emerson C. Perin MD, PhD, FA

Introduction

In this article, we describe the strategies and approaches developed at the Center for Clinical Research at Texas Heart Institute (THI) in Houston, Texas, to facilitate efficient participant recruitment for heart failure–related randomized controlled trials (RCTs). Randomized trials are typically complex in terms of the target population, protocol design, and intervention strategies — factors that can hinder the recruitment of a sufficient number of eligible participants. Thus, detailed upstream planning is crucial to guide recruitment efforts — especially in trials that focus on serious medical conditions such as heart failure — and a trained recruitment team is needed to execute protocol-specified tasks. Despite extensive literature on strategies for enhancing participant recruitment in research, little has been reported about the actual activities and experiences associated with recruitment and about the impact of organizational strategies on this work.

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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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Project Management: Introduction to Tools and Templates

By: Melissa Harris, MPA, CCRP
Director of Interventional Resources & Clinical Trials Unit
Pennington Biomedical Research Center at LSU

Abstract: Project management involves many complex components and moving parts. Prior to initiating a clinical trial, various types of project tools and templates can be used to successfully plan and execute a clinical trial. This article highlights tools that are readily available for project management, including Microsoft Excel, Access, Visio, Outlook, and SharePoint, as well as Web-based applications. Monitoring progress through various tracking mechanisms ensures successful clinical trial execution from recruitment through retention and follow-up.

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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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