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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Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

Operationalizing Serious Adverse Event Process

Tracy Popp, MBA
Previously: Director, Research Financial Operations Norton Healthcare, Inc.
Currently: Senior Director of Clinical Research, Tampa General Hospital

Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE) process beyond regulatory and clinical. Norton Healthcare, Inc. has developed policies and a workflow for operationalizing SAEs, including clinical, legal, billing, accounting, and budgeting capture. This article provides an overview of the way in which Norton Healthcare has done this as well as how other sites can also operationalize SAEs.

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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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Electronic Clinical Trial Management Systems: The Basics, Needs, and Outputs

Michael Wieczerzak
Associate Director, Clinical Quality Management, EMD Serono

Abstract: Sponsors and contract research organizations should be using electronic clinical trial management systems to efficiently oversee their trials. This article describes the basic structure of clinical trial management systems and the need for these systems. Benefits of using an integrated clinical trial management system are highlighted, including the ability to link to other systems, running reports, and outputs such as executive management reporting dashboards, listings, and merged datasets. Requirements for compliance with 21 CFR Part 11 are described.

Disclosure: The author is not writing this article on behalf of his employer.

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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


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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Virtual Project Management

Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP
Senior Director, Project
Covance, Inc.

Abstract: Clinical research project management is increasingly conducted globally across multiple time zones and cultures. In order to be successful, certain adaptations must be made to routine practices. This article describes key terms and basic concepts of virtual project management, considerations for effective communication and collaboration tools, and ways in which the Project Management Institute knowledge areas can be applied to a virtual framework. Situational examples are provided. While this has been written in the context of clinical trials performed by a biotech or pharmaceutical sponsor engaging a CRO, the same concepts could easily be extended to any geographically dispersed project team.

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