The Coordination of Clinical Research E-Book

• Herausgeber: Thieme
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 858

Veröffentlichungsjahr: 2020

Beschreibung

A novel and indispensable handbook for clinical research coordinators worldwide

Because "saying isn't doing; doing is doing": This fourth volume in Mohit Bhandari's series of methodology books, conceived as a transformational guide to executing research for those who coordinate it on a daily basis, focuses not on the design of research projects, but rather on the actual execution of such projects.

Key Features:

• International group of authors and practicing research coordinators with decades of collective hands-on experience
• Includes many crucial, but often neglected, topics such as principles of successful grant writing, working with study budgets, ethics and consent forms, regulatory versus standard trials, coordinating and conducting observational research and randomized clinical trials, and much more
• Many helpful templates and sample forms with checklists, consent forms, budget outlines, and more

A broad readership including scientists, physicians, surgeons, epidemiologists and statisticians, and industry research and development directors will welcome this unique and valuable book.

This book includes complimentary access to a digital copy on https://medone.thieme.com.

Leseprobe

The Coordination of Clinical Research

A Handbook for Research Coordinators

Mohit Bhandari, MD, PhD, FRCSCProfessorDepartment of SurgeryCanada Research ChairEvidence-Based Orthopaedic SurgeryMcMaster UniversityHamilton, Canada

Esther M. M. Van Lieshout, MSc, PhDAssociate ProfessorResearch CoordinatorTrauma Research UnitDepartment of SurgeryErasmus MCUniversity Medical Center RotterdamRotterdam, The Netherlands

35 illustrations

Library of Congress Cataloging-in-Publication Data is available from the publisher

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Contents

Preface

Acknowledgments

Contributors

Part I Getting Started

Esther M. M. Van Lieshout, Parag Sancheti

1Leadership and Management: The Principal Investigator and Research Coordinator

Heather Dwyer

1.1 Introduction

1.2 Leadership Styles

1.2.1 Autocratic Leaders

1.2.2 Democratic Leaders

1.2.3 Laissez-Faire Leadership

1.3 Building a Motivational Workplace

1.3.1 Emotional Intelligence

1.3.2 Physical Environment

1.3.3 Mandates and Vision

1.4 Mentoring New Staff

1.4.1 Orientation

1.4.2 Mentoring

1.4.3 Performance Reviews

1.5 Communicating with Staff

1.5.1 Communication Strategies

1.5.2 Communicating with External Staff

1.5.3 Relationship/Team Building

1.6 Organization

1.6.1 Documentation

1.6.2 Time Management

1.7 Management Competence

1.7.1 Managing Up and Managing Down

1.7.2 Professional Development

1.8 Conclusion

2Roles: Why a Research Coordinator Is Critical

Kelly Trask

2.1 Introduction

2.1.1 Why a Research Coordinator is Necessary

2.1.2 Education and Certification

2.1.3 Delegation of Duties

2.2 Duties

2.2.1 Study Participant Care

2.2.2 Data Management

2.2.3 Study Planning, Coordination, and Administration

2.2.4 Further Tasks

2.3 Practical Application

2.4 Conclusion

3Hiring: Characteristics of a Highly Qualified Research Coordinator

Milena R. Vicente

3.1 Introduction

3.1.1 The Research Coordinator Role

3.1.2 The Decision to Hire

3.1.3 Hiring Process

3.1.4 The Interview

3.1.5 Making a Decision

3.2 Desirable Characteristics

3.2.1 Communication Skills

3.2.2 Team Building Skills

3.2.3 Interpersonal Skills

3.2.4 Positive Attitude

3.2.5 Professional Skills

3.2.6 Regulatory and Ethics Guidelines

3.2.7 Computer Skills and Project Management

3.2.8 Clinical Experience

3.2.9 Writing Skills

3.2.10 Financial or Grant Management

3.3 The Newly Hired Research Coordinator

3.4 Conclusion

4Growth: From 0 to 100, Real Quick!

Nicole M. Harris, Darren M. Roffey

4.1 Introduction

4.2 Protocol Development

4.3 Informed Consent Form

4.4 Communication

4.5 Enthusiasm

4.6 Training

4.7 Recruitment

4.7.1 Identifying Eligible Patients

4.7.2 Who will approach the patient?

4.7.3 When will the patient be contacted?

4.7.4 Where will the patient be contacted?

4.7.5 How will patient contact occur?

4.8 Practical Application

4.8.1 Designing a Recruitment Plan

4.9 Conclusion

Part II What Every Research Coordinator Needs To Know

Ernesto Guerra Farfán, Dinesh Kumbhare, Anthony Adili

5What Is Evidence-Based Medicine?

Ellie B. M. Landman

5.1 Introduction

5.2 The History of Evidence-Based Medicine

5.3 Principles of Evidence-Based Medicine

5.3.1 Best Available Evidence

5.3.2 Evaluate Available Evidence

5.3.3 Application of Evidence in the Care for Individual Patients

5.4 Where Do We Stand in Evidence-Based Medicine Today?

5.4.1 Criticism of Evidence-Based Medicine

5.4.2 Clinical Research

5.5 Practical Application

5.5.1 Clinical Example

5.6 Conclusion

6Randomized Controlled Trials

Miriam Garrido Clua

6.1 Introduction

6.2 What Is a Randomized Controlled Trial?

6.2.1 Study Population

6.2.2 Randomized Controlled Trial Study Design

6.2.3 Random Assignment (Randomization)

6.2.4 Blinding

6.3 Outcome Measurement

6.3.1 Reliability and Validity of Outcomes Measures

6.4 Quality Control and Data Collection

6.5 Recruitment of Study Participants

6.5.1 Tips for Coordinators

6.6 Participant Adherence

6.7 Assessing and Reporting Adverse Events (AEs)

6.7.1 Monitoring a Randomized Controlled Trial

6.8 Ethical Considerations

6.9 Practical Application

6.10 Conclusion

7Observational Studies

Pieta Krijnen

7.1 Introduction

7.2 Types of Observational Studies

7.2.1 Cohort Studies

7.2.2 Case–Control Studies

7.2.3 Case Series

7.3 Pros and Cons of Observational Studies

7.4 Types of Bias Associated with Observational Studies

7.5 Designing Observational Studies

7.5.1 General Information

7.5.2 Define Research Questions Based on a Literature Review

7.5.3 Choose the Study Design

7.5.4 Define the Study Population

7.5.5 Describe the Treatment and Procedures

7.5.6 Describe the Study Parameters

7.5.7 Outcomes and Other Study Parameters

7.5.8 Study Procedure

7.5.9 Statistical Analysis Plan

7.5.10 Ethical Considerations/Data Handling

7.6 Performing the Study

7.6.1 Initiation Phase

7.6.2 Data Collection

7.6.3 Patient Inclusion in Prospective Studies

7.6.4 Keep the Staff Informed and Committed during the Study

7.7 Data Analysis

7.7.1 Dealing with Confounding

7.7.2 Handling Missing Outcome Data

7.8 Reporting

7.9 Practical Application

7.9.1 Background

7.9.2 Study Objective

7.9.3 Study Design

7.9.4 Patients

7.9.5 Treatment

7.9.6 Study Outcomes and Other Parameters

7.9.7 Sample Size

7.9.8 Statistical Analysis

7.9.9 Ethical Considerations

7.10 Conclusion

8Surveys

Miriam Garrido Clua

8.1 Introduction

8.1.1 What Is a Survey Study?

8.2 Research Methods

8.2.1 Questionnaires

8.2.2 Face-to-Face Interviews

8.2.3 Telephone Interviews

8.3 Selecting the Survey Method

8.3.1 Population

8.3.2 Research Question

8.3.3 Content of the Study

8.3.4 Bias Issues

8.3.5 Resources

8.4 Sample and Sampling

8.4.1 Random Sampling

8.4.2 Nonrandom Sampling

8.5 Research Tool Design

8.5.1 Types of Questions

8.5.2 Questionnaire Layout

8.5.3 Question Wording

8.5.4 Question Order

8.6 Training the Interviewers

8.7 Pilot Testing

8.8 Translation

8.9 Reliability and Validity

8.10 Analysis of Survey Data

8.11 Ethics of Survey Research

8.12 Practical Application

8.13 Conclusion

9Qualitative Studies

Patricia Schneider

9.1 Objectives

9.2 Introduction

9.2.1 Why Qualitative Research?

9.2.2 What is Qualitative Research?

9.2.3 Qualitative versus Quantitative Research

9.2.4 Advantages of Qualitative Research

9.3 Designing and Conducting the Study

9.3.1 General Study Details

9.3.2 Research Question

9.3.3 Research Objectives

9.4 Study Methods

9.4.1 Ethnography

9.4.2 Grounded Theory

9.4.3 Phenomenology

9.5 Sampling

9.5.1 Purposive Sampling

9.5.2 Quota Sampling

9.5.3 Chain-Referral (Snowball) Sampling

9.6 Sample Size

9.7 Qualitative Data Collection

9.7.1 Observation

9.7.2 Interview

9.7.3 Focus Group

9.7.4 Discussion Guide/Interview Script Development

9.7.5 Interview/Focus Group Question Development

9.7.6 Collecting Initial Demographic Details

9.7.7 Obtaining Adequate Responses

9.7.8 Transcription of Interviews and Focus Groups

9.8 Data Analysis and Interpretation

9.8.1 Qualitative Data Analysis Approaches

9.8.2 Qualitative Data Coding

9.8.3 Data Management Software

9.9 Reporting and Disseminating the Study

9.9.1 Where to Publish?

9.9.2 Authorship

9.10 Ethical Implications

9.10.1 Informed Consent

9.10.2 Protecting Confidentiality

9.11 Other Considerations

9.11.1 Generalizability

9.11.2 Ambiguities

9.11.3 Frequency

9.12 Types of Bias Associated with Qualitative Studies

9.12.1 Strategies for Managing Bias

9.13 Practical Application

9.13.1 Background

9.13.2 Study Objective

9.13.3 Study Design

9.13.4 Participants

9.13.5 Discussion Guide

9.13.6 Sample Size

9.13.7 Ethical Considerations

9.13.8 Analysis

9.13.9 Reporting

9.14 Conclusion

9.15 Appendix A: Collaborative Research Focus Group Discussion Guide

9.15.1 Welcome, Introductions, and Informed Consent

9.15.2 Discussion Topics

10Principles of Good Clinical Practice and Research Conduct

Naveen Khan

10.1 Introduction

10.2 History of Good Clinical Practice

10.2.1 Revisiting a Drastically Different Era of Clinical Studies

10.3 The History of GCP Guidelines

10.4 The ICH-GCP Guidelines

10.4.1 Introduction and Major Principles

10.4.2 Roles and Responsibilities of Involved Parties

10.4.3 Essential Documents

10.4.4 Advantages of the ICH-GCP Guidelines

10.5 Future Directions and Challenges

10.5.1 Globalization and the Universal Adoption of GCP

10.5.2 Technological Advancements

10.6 Practical Application

10.6.1 Good Clinical Practice Checklist for Clinical Research Coordinators

10.7 Conclusion

Part III From Idea to Study Start-Up

Rebecca Ivers, Jack Chun-Yiu Cheng

11Principles of Grant Writing: Tips for a Successful Experience

Milena R. Vicente, Sarah Desjardins

11.1 Introduction

11.2 Getting Started

11.2.1 Start early

11.3 Conclusion

11.4 Practical Application

11.4.1 Common issues That Result in Grant Rejection

12Dollars and “Sense”: A Guide to Research Finances

Johanna Dobransky, Darren M. Roffey

12.1 Introduction

12.2 Planning and Creating a Research Budget

12.2.1 Preplanning Phase

12.2.2 Funding Source

12.2.3 Centralized versus Decentralized Budgetary Management

12.2.4 Financial Lifecycle

12.2.5 Planning the Budget

12.2.6 Key Expenses

12.2.7 Direct and Indirect Costs

12.2.8 Negotiating the Study Budget

12.2.9 Need for a Contingency Budget

12.2.10 Pitfalls Associated with Budgetary Planning

12.3 Ongoing Monitoring of a Research Budget

12.3.1 Invoicing and Payments

12.3.2 Amending the Study Budget

12.4 Study Termination

12.4.1 Premature Study Termination

12.5 Practical Application

12.6 Conclusion

13Maintaining Records and the Trial Master File

Alisha Garibaldi

13.1 Introduction

13.1.1 What Is a Trial Master File?

13.1.2 Why All of the Documentation?

13.1.3 Setting up a Trial Master File at a Participating Clinical Site

13.1.4 Setting up a Trial Master File at a Methods Center

13.1.5 Document Control and the Trial Master File

13.1.6 When the Methods Center Is also a Participating Clinical Site

13.1.7 Do I Really Need a Binder?

13.1.8 Spotlight: The Clinical Site Manual

13.1.9 Internal audits

13.1.10 Practical Application

13.2 Conclusion

14Ethics Submissions

Bregje J. W. Thomassen, Michel Sourour, Kesh Reddy

14.1 Introduction

14.1.1 Research Ethics Committee

14.1.2 Research Ethics Committee Submission

14.1.3 Review Process

14.1.4 Multicenter Human Studies and International Studies

14.2 Conclusion

15The Basics of Research Contracts

Caroline Woods

15.1 Introduction

15.2 Different Types of the Agreements

15.2.1 Grant Funding

15.2.2 Collaboration

15.2.3 Sites

15.2.4 Industry Involved in Investigator Initiated Study

15.2.5 Industry-Initiated Study Agreement

15.3 The Parts of an Agreement

15.3.1 The Parties

15.3.2 The Preamble

15.3.3 The Clauses

15.3.4 Signatories

15.4 Practical Application

15.4.1 Examples of Clauses

15.5 Study Budget

15.5.1 Overview

15.5.2 The Terms

15.6 Intellectual Property

15.6.1 Overview

15.6.2 The Terms

15.7 Publication Clause

15.7.1 Overview

15.7.2 The Terms

15.8 Conclusion

16How to Start-Up a Study

Ellie B. M. Landman

16.1 Introduction

16.2 Study Start-Up Phase

16.2.1 Identify and Contact Sites

16.2.2 Feasibility

16.2.3 Clinical Trial Agreement Negotiation

16.2.4 Regulatory and Ethics Approval

16.2.5 Site Initiation Visit

16.2.6 Site Activation

16.3 Challenges Encountered During Start-Up

16.3.1 Protocol Adherence

16.3.2 Meeting Recruitment Goals

16.3.3 Delaying Factors

16.3.4 Guidelines for Good Clinical Practice

16.3.5 Drug, Device, or Procedure

16.4 Practical Application

16.5 Keys to Success

16.6 Conclusion

Part IV Study Execution and Close-Out

Aaron Nauth, Kim Madden, Paul Tornetta

17Screening and Recruiting Participants

Nienke Wolterbeek

17.1 Introduction

17.2 Recruitment, prescreening, and study screening

17.3 Barriers for Inclusion

17.4 Ethical Considerations

17.5 How to Improve Recruitment and Screening

17.5.1 Target Population

17.5.2 Recruitment Plan and Contact Methods

17.5.3 Screening Mechanism

17.5.4 Study Design

17.6 Practical Application

17.6.1 Recruitment

17.6.2 Prescreening Phase

17.6.3 Screening Phase

17.7 Conclusion

18Obtaining Informed Consent

Chandni Patel, Nazanin Barkhordari

18.1 Introduction: What Is Informed Consent?

18.2 The Informed Consent Process

18.3 Voluntary Consent

18.4 Consent Should Be Informed

18.5 Basic Elements of Informed Consent

18.6 Participants Must Be Free to Withdraw

18.7 Consent Is an Ongoing Process

18.8 Decision-Making Capacity

18.9 Language Understandable to the Participant and the Legally Authorized Representative

18.10 Practical Application

18.11 Conclusion

19Collecting Data: Paper and Electronic Data Capture Systems

Esther M. M. Van Lieshout, Stephanie M. Zielinski

19.1 Introduction

19.2 The Aim of Data Collection in a Clinical Study

19.3 What Data Should Be Collected

19.4 Source Data

19.5 Multidisciplinary Approach

19.6 Case Report Forms, Remote Data Entry, and Electronic Data Capture

19.7 Datasheets on Paper versus eCRF

19.8 Examples of Available EDCs

19.9 Case Report Form Design Guidelines

19.9.1 Response Types and Coding

19.10 Conclusion

20Follow-Up: Why It Is Important and How to Minimize Loss to Follow-Up

Stephanie L. Tanner

20.1 Introduction

20.2 Why Is Follow-Up Important?

20.3 Why Are Participants Lost to Follow-Up (Why Do Patients Leave a Study)?

20.4 Strategies to Minimize Loss to Follow-Up

20.4.1 Study Design Strategies

20.4.2 Methods Center/Sponsor Study Management

20.4.3 Local Site Study Management to Maintain Follow-Up

20.4.4 Retention Strategies

20.5 Practical Application

20.6 Conclusion

21How to Close Out a Study

Kelly Trask

21.1 Introduction

21.2 Reasons for Study Closure

21.3 The Process of Study Closure

21.3.1 Preparing for the Closeout Visit

21.4 The Closeout Visit

21.4.1 What if There Isn’t a Closeout Visit?

21.5 After the Closeout Visit

21.5.1 Closing the Study with the Ethics Committee

21.6 Record Retention

21.7 After the Study Closure

21.8 Practical Application

21.9 Conclusion

22Knowledge Dissemination: Getting the Word Out!

Cheryl Kreviazuk, Darren M. Roffey

22.1 Introduction

22.1.1 Knowledge Dissemination

22.1.2 Maximizing Uptake of Knowledge Dissemination

22.1.3 Developing an Effective Dissemination Plan

22.1.4 Traditional Knowledge Dissemination

22.1.5 Nontraditional Knowledge Dissemination

22.1.6 Traditional versus Nontraditional Knowledge Dissemination: Which Is Better?

22.1.7 Barriers to Implementation

22.2 Practical Application

22.3 Conclusion

Part V Advanced Principles of Research Coordination

Ydo V. Kleinlugtenbelt, Rudolf W. Poolman

23Regulatory Trials: Key Differences from Standard Trials

Deborah J. Carr

23.1 Introduction

23.1.1 What Are Clinical and Regulatory Trials?

23.2 History of Regulation and International Harmonization

23.2.1 Role of the Regulatory Agency

23.2.2 Structure of Regulatory Trials

23.2.3 Key Differences between Standard Clinical Trials and Regulatory Trials

23.2.4 Good Clinical Practice Relevant in Regulatory Trials

23.2.5 Follow a Detailed Protocol

23.2.6 Trial Registration

23.2.7 Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results

23.2.8 Safety Reporting

23.3 The Research Coordinator’s Responsibilities

23.4 Standard Definitions

23.5 Expedited Reporting: When, What, Why, and How?

23.5.1 What and Why?

23.5.2 When?

23.5.3 Event Time Frame

23.5.4 How?

23.5.5 Documentation

23.5.6 Audits

23.5.7 Investigator Qualifications and Agreements

23.5.8 Clinical Study Report

23.5.9 Practical Application

23.6 Conclusion

24How to Survive a Site Audit

Annemieke I. J. M. Schellevis-Mintiens, Esther M. M. Van Lieshout

24.1 Introduction

24.2 The Difference between Monitoring and Auditing

24.2.1 First Line of Defense: Procedures

24.2.2 Second Line of Defense: Monitoring

24.2.3 Third Line of Defense: Auditing

24.3 What to Do When You Find Out You Will Be Audited

24.4 Content of the Study: The Big Picture

24.5 Documentation

24.6 Meetings and Interviews with Auditors

24.6.1 Introduction or Start–Up Meeting

24.6.2 Audit Interviews

24.6.3 Daily Briefings

24.6.4 Informal Conversations in between Audit Events

24.6.5 Final Audit Meeting

24.7 Role of the PI, Research Coordinator, and Team

24.8 Practical Aspects: Travel, Space, Food and Drinks

24.9 Report and Corrective Action/Preventive Action (CAPA) Plan

24.9.1 Audit Report

24.9.2 Corrective Action/Preventive Action Plan (CAPA Plan)

24.9.3 Life after the Audit

24.10 Practical Application

25Monitoring in a Clinical Study: Why and How?

David Pogorzelski

25.1 Introduction

25.2 Purpose of Monitoring

25.3 Responsibilities, Extent, and Nature of Monitoring

25.4 Monitor Qualifications

25.5 Monitoring Visits

25.6 Site Selection Visit

25.7 Site Initiation Visit

25.8 Routine Monitoring Visits

25.9 Closeout Visit

25.10 Monitoring Reports

25.11 Centralized Monitoring

25.12 Risk-Based Monitoring

25.13 Data and Safety Monitoring Committee

25.14 Practical Application: Ensuring an AWESOME Site Visit

25.15 Scheduling

25.16 Preparation

25.17 Previous Monitoring Reports

25.18 During the Visit

25.19 After the Visit

25.20 Managing Expectations

26Managing Large Studies: Organization and Committees

Stephanie L. Tanner

26.1 Introduction

26.2 Study Management Committee

26.2.1 Study Principal Investigator

26.2.2 Co-investigators

26.2.3 Study Manager

26.2.4 Database Managers

26.2.5 Financial Analysts/Business Analysts

26.2.6 Research Assistants

26.2.7 Study Statistician

26.2.8 Study Monitors

26.2.9 Additional Team Members

26.3 Additional Study Oversight Committees

26.3.1 Steering Committee

26.3.2 Data Safety Monitoring Committee/Data Safety Monitoring Boards

26.3.3 Adjudication Committee

26.4 Other Study Committees

26.4.1 Writing Committee/Data Dissemination Committee

26.4.2 Audit/Monitoring Committee

26.5 Practical Application

26.6 Conclusion

27International Research: Challenges and Successes

Chuan Silvia Li, Mandeep S. Dhillon

27.1 Introduction

27.2 Study Planning Phase

27.3 Ethics Approval

27.4 Consent Process

27.5 Motivating Coinvestigators

27.6 Language Challenges

27.7 Time Zone Difference

27.8 Shortage of Research Staff

27.9 Data Collection Process

27.10 Lower Data Quality

27.11 Timeline Delay

27.12 Financial Challenges

27.13 Legal Considerations

27.14 Practical Application

27.14.1 Laying the Groundwork—The INORMUS Pilot Study

27.15 Conclusion

Part VIA Coordinator’s Toolbox

Vinicius Y. de Moraes, Ashok K. Shyam

Toolbox A

Toolbox B

Toolbox C

Toolbox D

Toolbox E

Toolbox F1

Toolbox F2

Toolbox F3

Toolbox F4

Toolbox F5

Toolbox F6

Toolbox F7

Toolbox F8

Toolbox F9

Toolbox F10

Toolbox F11

Toolbox G

Index

Preface

The Coordination of Clinical Research: A Handbook for Research Coordinators is the fourth book in our series on clinical research after Clinical Research for Surgeons, Advanced Concepts in Surgical Research, and Getting Your Research Paper Published. It was appropriate, for many reasons, to provide our initial offering as one of the principles of clinical research. For those who understood the principles, we provided advanced concepts in the conduct of studies with insights into newer methodological issues germane to any health care research. Successful researchers are those who are able to disseminate the results of their work. The primary output, or one might say deliverable, is a high-impact publication delivered to as many readers as possible. Our third book in the series details the anatomy of a research paper to guide researchers in telling the story of their results and maximizing impact in their message.

This book in the series is a manifesto for clinical research coordinators worldwide who understand deeply that the execution of research is as important as its design. True to the adage, “Saying isn’t doing, doing is doing,” most clinical research programs struggle not for the lack of ideas, but rather the lack of execution. Critical to any successful research program are passionate leaders, motivated investigators, and highly trained research coordinators. Arguably, the research coordinator is the pillar of a study’s day-to-day execution.

We have leveraged an international group of authors and practising research coordinators with decades of collective hands-on experience to provide insights on their roles within a study, detail key aspects of the coordination of research, and give pragmatic tips based on their collective experience. To further assist readers, we have collated critical templates and checklists that should form a research coordinator’s toolbox. These range from sample consent forms to sample budget templates.

This book is for you—whether you are new to clinical research or a seasoned researcher. Understanding the daily “how-to” activities in the conduct of clinical research is fundamental to the execution of high-quality studies. So, let’s get started because “Saying isn’t doing, doing is doing.”

Mohit Bhandari, MD, PhD, FRCSCEsther M. M. Van Lieshout, MSc, PhD

Acknowledgments

The Osteosynthesis and Trauma Care Foundation (OTCF) is greatly indebted to Dr. Mohit Bhandari and Dr. Esther M. M. Van Lieshout, the two editors of this book, who have supported and enriched the research program of OTCF in many ways since its inception. Their series of research methodology text-books has become the basis for research grants and training courses, and guided many scientists and surgeons in their work. The OTCF Research Committee has benefitted from their participation and contributions over many years.

For the current book, a special thanks is due to Dr. Kim Madden, the managing editor, for her relentless coordination efforts to keep all participants on board and deliver their parts, and for her diligence, dedication, and persisting patience.

This book has 6 sections and 27 chapters in which the contributors have put in their individual knowledge and donated their time to amass a comprehensive and detailed coverage of all aspects pertinent to coordinating clinical research. Our sincere thanks to all of them, as well as to the 14 section editors who accompanied the shaping of this book from its planning to the final manuscript.

The OTCF is also grateful to Stryker for a research grant, without which the present book would have not been possible.

Richard HelmerGeneral ManagerOTC Foundation

Contributors

Editors

Mohit Bhandari, MD, PhD, FRCSC

Professor

Department of Surgery

Canada Research Chair

Evidence-Based Orthopaedic Surgery

McMaster University

Hamilton, Canada

Esther M. M. Van Lieshout, MSc, PhD

Associate Professor

Research Coordinator

Trauma Research Unit

Department of Surgery

Erasmus MC

University Medical Center Rotterdam

Rotterdam, The Netherlands

Managing Editor

Kim Madden, PhD

Assistant Professor

Research Methodologist

Department of Surgery

McMaster University

St. Joseph's Healthcare Research Institute

Hamilton, Canada

Section Editors

Anthony Adili, MD, P.Eng, FRCSC

Associate Professor

Orthopaedic Surgeon

Department of Surgery

McMaster University

Hamilton, Canada

Jack Chun-yiu Cheng, MBBS, MD(CUHK), FRCSE, FRCS(G), FRCSED (Orth), FACS, FHKCOS, FCSHK, FHKAM (Orthopaedic Surgery)

Choh-ming Li Research Professor

Department of Orthopaedics and Traumatology

The Chinese University of Hong Kong

Orthopaedic Surgeon

Department of Orthopaedics and Traumatology

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Vinicius Y. de Moraes, MD, PhD

Orthopaedic Hand Surgeon

Department of Orthopaedics and Traumatology

Universidade Federal de São Paulo

São Paulo, Brazil

Ernesto Guerra Farfán, MD

Orthopaedic Surgeon

Department of Surgery

Vall d’Hebron University Hospital

Barcelona, Spain

Rebecca Ivers, MPH, PhD

Professor

School of Public Health and Community Medicine

University of New South Wales

Sydney, Australia

Ydo V. Kleinlugtenbelt, MD, PhD

Orthopaedic Trauma Surgeon

Department of Orthopaedic and Trauma Surgery

Deventer Hospital

Deventer, The Netherlands

Dinesh Kumbhare, MD, PhD, FRCPC, FAAPMR

Associate Professor

Department of Medicine

University of Toronto

Toronto, Canada

Kim Madden, PhD

Assistant Professor

Research Methodologist

Department of Surgery

McMaster University

St. Joseph's Healthcare Research Institute

Hamilton, Canada

Aaron Nauth, MD, MSc, FRCSC

Orthopaedic Surgeon

Division of Orthopaedic Surgery

Assistant Professor

University of Toronto

Toronto, Canada

Rudolf W. Poolman, MD, PhD

Orthopaedic Surgeon

Department of Orthopaedic Surgery

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, The Netherlands

Parag Sancheti, FRCS (Ed), MS (Ortho), DNB (Ortho), MCh (UK)

Professor and Chair

Sancheti Institute for Orthopaedics and Rehabilitation

Pune, India

Ashok K. Shyam, MS (Ortho)

Orthopaedic Surgeon

Chief Researcher

Sancheti Institute for Orthopaedics and Rehabilitation

Pune, India

Paul Tornetta III, MD

Chief and Chair

Professor

Residency Program Director

Department of Orthopaedic Surgery

School of Medicine

Boston University

Director

Orthopaedic Trauma

Boston Medical Center

Boston, Massachusetts

Esther M. M. Van Lieshout, MSc, PhD

Associate Professor

Research Coordinator

Trauma Research Unit

Department of Surgery

Erasmus MC

University Medical Center Rotterdam

Rotterdam, The Netherlands

Authors

Nazanin Barkhordari, MSc, PMP, CCRP

Research Coordinator

Department of Surgery

McMaster University

Hamilton, Canada

Deborah J. Carr, CHE, MSc

Epidemiologist and Biostatistician

Global Research Solutions

Burlington, Canada

Sarah Desjardins, BSc

Research Technician

Division of Orthopaedic Surgery

St. Michael’s Hospital

Toronto, Canada

Mandeep S. Dhillon, MBBS, MS, FAMS, FRCS (Eng)

Head

Department of Orthopaedics

Department of Physical Medicine and Rehabilitation

Professor

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Johanna Dobransky, MHK, CCRP

Clinical Research Program Manager

Division of Orthopaedic Surgery

The Ottawa Hospital

Ottawa, Canada

Heather Dwyer, BScH

Associate Manager

Trauma Research

Department of Surgery

McMaster University

Hamilton, Canada

Alisha Garibaldi, MSc

Associate Manager

Trauma Research

Department of Surgery

McMaster University

Hamilton, Canada

Miriam Garrido Clua, MSc

Research Coordinator

Neuroimaging and ALS Research

Division of Neurology

University of Alberta

Edmonton, Canada

Nicole M. Harris, BSc

Clinical Research Coordinator

Division of Orthopaedic Surgery

The Ottawa Hospital

Ottawa, Canada

Naveen Khan, MPH, CCRP

Research Associate

Global Research Solutions Inc.

Burlington, Canada

Cheryl Kreviazuk, BA

Clinical Research Coordinator

Division of Orthopaedic Surgery

The Ottawa Hospital

Ottawa, Canada

Pieta Krijnen, PhD

Research Coordinator

Trauma Center West Netherlands

Assistant Professor

Department of Trauma Surgery

Leiden University Medical Center

Leiden, The Netherlands

Ellie B. M. Landman, PhD

Research Coordinator

Department of Orthopaedic and Trauma Surgery

Deventer Hospital

Deventer, The Netherlands

Chuan Silvia Li, MSc

Research Coordinator

Department of Surgery

McMaster University

Hamilton, Canada

Chandni Patel, BSc

Research Associate

Global Research Solutions Inc.

Burlington, Canada

David Pogorzelski, MSc

Project Manager

Department of Surgery

McMaster University

Clinical Research Associate

Global Research Solutions

Hamilton, Canada

Kesh Reddy, MBBS, FRCSC, FACS, DABNS

Clinical Professor

Neurosurgeon

Department of Surgery

McMaster University

Hamilton, Canada

Darren M. Roffey, PhD

Clinical Research Associate

Division of Orthopaedic Surgery

The Ottawa Hospital

Clinical Epidemiology Program

Ottawa Hospital Research Institute

Ottawa, Canada

Annemieke I. J. M. Schellevis–Mintiens, MSc

Auditor

Department of Audit and Risk

Erasmus MC

University Medical Center Rotterdam

Rotterdam, The Netherlands

Patricia Schneider, BSc

Associate Manager

Orthopaedic Oncology Research

Department of Surgery

McMaster University

Hamilton, Canada

Michel Sourour, MD

Neurosurgery Resident

Department of Surgery

McMaster University

Hamilton, Canada

Stephanie L. Tanner, MS

Research Manager

Department of Orthopaedic Surgery

Prisma Health Upstate

Clinical Instructor

University of South Carolina School of Medicine Greenville

Greenville, South Carolina

Bregje J. W. Thomassen, PhD

Coordinator

Centre of Expertise in Health Innovation

The Hague University of Applied Sciences

The Hague, The Netherlands

Kelly Trask, MSc

Research Manager

Division of Orthopaedic Surgery

Nova Scotia Health Authority

Halifax, Canada

Esther M. M. Van Lieshout, MSc, PhD

Associate Professor

Research Coordinator

Trauma Research Unit

Department of Surgery

Erasmus MC

University Medical Center Rotterdam

Rotterdam, The Netherlands

Milena R. Vicente, RN, CCRP

Research Program Manager

Division of Orthopaedic Surgery

St. Michael’s Hospital

Toronto, Canada

Nienke Wolterbeek, PhD

Research Coordinator

Department of Orthopaedic Surgery

St. Antonius Hospital

Nieuwegein, Utrecht, The Netherlands

Caroline Woods, MSc

Senior Agreements Officer

Health Research Services

McMaster University

Hamilton, Canada

Stephanie M. Zielinski, MD, PhD

Trauma Surgery Fellow

Department of Surgery

Maasstad Hospital

Rotterdam, The Netherlands

Part I

Getting Started

1 Leadership and Management: The Principal Investigator and Research Coordinator

2 Roles: Why a Research Coordinator Is Critical

3 Hiring: Characteristics of a Highly Qualified Research Coordinator

4 Growth: From 0 to 100, Real Quick!

1 Leadership and Management: The Principal Investigator and Research Coordinator

Heather Dwyer

Abstract

This chapter discusses leadership styles and when they are appropriate to use. It then considers what it takes to build a motivational workplace, approaches to use when mentoring and communicating with staff, and strategies to improve organization. Finally, it explores how to continue to develop management skills through professional development.

Keywords: leadership, management, team-building

1.1 Introduction

Clinical research involves a team of people, such as principal investigators, research coordinators, research assistants, pharmacists, statisticians, and so forth, working toward the goal of improving the lives of individuals. Each of these team members has a specific role to contribute to a research project and is all integral to the success of the project. One of the fundamental tasks of a research coordinator is to manage and expedite all aspects of a study to ensure that it is run according to the protocol and applicable guidelines and completed in a timely manner. To accomplish this, the research coordinator needs to serve as the central point of contact in the study to ensure that tasks are distributed to the right team members and that team members have all the information required to complete the task. Some research coordinators have personnel management duties in addition to project management duties. To succeed in any research coordinator role, it is important to have exceptional leadership and management skills. This chapter will outline leadership styles and will follow with practical approaches to build a motivational workplace with team members who are engaged and strategies to have a team that works efficiently and within the vision of your organization.

1.2 Leadership Styles

To successfully lead a team of junior research coordinators, research assistants, and support staff, it is important to understand varying leadership styles. Each leadership style can be effective in different situations; therefore, it is important to recognize the benefits and drawbacks of each style and when to implement them. Many great leaders employ strategies from each and having a strong understanding of when they are best implemented is key for a strong research team. Additionally, knowing how the principal investigator leads his/her team will help create a strong working relationship with the research coordinator, who can then delegate tasks appropriately to the staff. On a very basic level, leaders can be classified as autocratic, democratic, and laissez-faire.

1.2.1 Autocratic Leaders

Autocratic leaders traditionally control decisionmaking without input from group members. They make choices based on their own ideas and do not involve suggestions from others. Autocratic leadership is often seen in military settings or dangerous work environments where there is no room for error and tasks must be completed a certain way. Additionally, in times of uncertainty, people often look for autocratic leaders who are strong and direct to provide a clear path to follow.1 This leadership style can also be beneficial for employees who are unmotivated or inexperienced. The autocratic leader takes all responsibility for team decisions, is focused on completing the task at hand and not the well-being of the team, is not involved socially with the team, and often motivates with threats and punishments instead of rewards. These types of leaders are often busy individuals who are dealing with high stress levels. A principal investigator or research coordinator leading the team in an autocratic style can lead to employees becoming workhorses as staff are not encouraged to contribute ideas and experiences that may enhance the research. An autocratic principal investigator or research coordinator will be demanding and uncompromising. Staff who are intrinsically motivated and highly skilled will feel dampened by an autocratic leader and will hinder the team’s creativity and productivity. With that being said, when a crisis arises, an autocratic leader can be very successful at handling the matter at hand effectively and with confidence.

1.2.2 Democratic Leaders

Democratic leaders promote idea sharing and encourage all team members to be included and involved in the decision-making process. A democratic leader will encourage staff to complete training and continue education to ensure the completion of assigned duties, will use democratic deliberation when decisions are to be made, and will ensure that all team members are heard and a respectful environment is maintained. Democratic leadership often leads to high job satisfaction although the decision-making process can be cumbersome and time-consuming.2 Democratic leaders find solutions to difficult problems by engaging the team, who generally feel supported and have a sense of a strong team environment. Democratic leaders can be construed as indecisive during a crisis when they are looking for the team’s input and can often spend a great deal of time reaching a solution when all team members need to be consulted. If a crisis arises, it is important for democratic leaders to recognize that decisions need to be made in a timely matter and their preferred choice of leadership may not be ideal. Democratic leadership is an ideal style in theory due to the high team satisfaction; however, it is important to remember that a true democratic leader is often impeded by the slow process and practical results require a great deal of time and effort.

1.2.3 Laissez-Faire Leadership

The laissez-faire leader is often seen as an “avoidant” leader where team members make decisions and solve problems on their own.3 These leaders have a hands-off approach and give complete freedom to their team. Laissez-faire leaders often give little support to their subordinates but provide them with the required tools and resources needed to complete a task. This leadership style works best with an experienced team where the tasks at hand become easier when the laissez-faire leader steps back and allows the experts to do their best. Additionally, laissez-faire leadership is useful in situations where there are many decisions to be made, the decision-making is not complex, and when team members have routine duties that are dictated by established regulations.4 Conversely, team members that are inexperienced and unmotivated will find this leadership style challenging and can thus lead to decreased job satisfaction.

1.3 Building a Motivational Workplace

A work environment that is encouraging and motivational will benefit any study that is being conducted. As a rule, people want to feel included and know that their input is valued and being considered. If the team is feeling this way, there is a greater sense of camaraderie and staff will often go above and beyond to ensure a successful study. Leaders who are mindful of people’s needs, both emotionally and physically, will be seen as an inclusive, empathetic, and approachable manager.

1.3.1 Emotional Intelligence

The idea of emotional intelligence came to light in the 1990s when Goleman (1995) wrote a best-selling book titled Emotional Intelligence: Why It Can Matter More than IQ. There have been alternate models of emotional intelligence that have been developed since but simply stated, emotional intelligence is the ability to use both thoughts and feelings while making decisions. Recognizing your own emotions and those of others and using this emotional information to steer thinking and behavior show a high level of emotional intelligence. The Mayer–Salovey–Caruso Emotional Intelligence Test is the gold standard for testing emotional intelligence. This test is available to take online and will provide you with a debriefing guide to help you focus on the areas that need improvement. Having strong emotional intelligence has been linked to increased job satisfaction, successful interactions with colleagues, and excellent strategies for conflict management.5 High emotional intelligence scores in managers have also been shown to correlate positively with managerial performance. Generally speaking, your team members come to work to contribute to the best of their ability and to be productive. If you are finding that this is not the case, then it is up to you to determine why. Perhaps there are issues in the team member’s personal life that are monopolizing her attention. Maybe the team member has had an altercation with a colleague or feels overworked. It is a manager’s responsibility to have the strong emotional intelligence to see when the team is not functioning at its best and come up with solutions to help the team. Having grace when you notice a team member is struggling shows empathy and will allow the team members to work through the issues plaguing them and refocus their attention to the task at hand. A conversation with a team member where it is acknowledged that you have noticed that they have not been themselves for the last few weeks and asking if there is anything that you can do to help is a great way to build a strong relationship with your team. The team member may not divulge what is bothering them, but they will know that you are available if and when they feel they need to discuss the issue. Being kind and empathetic in your managerial position will encourage your team members to do the same and will help to build strong relationships.

1.3.2 Physical Environment

A work environment that is inclusive of everyone’s needs will foster a strong team dynamic and ensure that all team members feel valued. Ideally, an office that provides spaces to work independently such as separated desks as well as rooms for meetings and brainstorming sessions will provide an opportunity for all staff to contribute and work efficiently. Basic necessities must be considered such as clean air, appropriate lighting, adequate temperature control, and ergonomic desks. Ideally, the office space will have natural light, desks that are able to adapt to all team members’ needs, and an appropriate break room to allow staff to step away from their desks to recharge. If your workspace is not ideal, it is important to listen to your team members and hear their needs when voiced. Making workspaces more comfortable does not need to be an expensive venture and responding to your team member’s needs in creative ways will show your high emotional intelligence. Additionally, encouraging staff to step away from their desks during breaks and lunch will not only improve the overall health of the staff but will also show that you appreciate your team as individuals, not just employees.

1.3.3 Mandates and Vision

As we know, a motivated team is a team that works together toward a common goal. It is essential that the vision of the organization and the specific department is introduced early in a new team member’s career during orientations and reinforced often. In large groups, yearly retreats can gather all stakeholders and team members to share ideas, discuss challenges, and plan for the future. Smaller groups may find it enough to reiterate the vision at staff meetings and in daily communication. As a manager and leader, being excited and engaged in the vision yourself will help your team members feel the same way. It is important to remember that the team grows to continue engaging with your team to promote the vision of your group.

1.4 Mentoring New Staff

Hiring new staff can be a daunting task. Staffing can be one of the most expensive components in clinical research but is also the most important. It is critical to consider not only the qualifications of a potential new hire but also the disposition of the candidate and potential fit into the program. An inexperienced candidate who is personable and excited about the position can make a better team member than one that has the practical experience required who is simply looking for a job. The time and energy invested into a new hire are extensive; therefore, it is important to find a team member whose work ethic and attitude are appropriate for the program and someone who is committed to the vision of the program. An accomplished manager will understand that investing time and energy into new staff will not only help the new team member feel welcome and included but will also benefit the team long term. More information on hiring can be found in Chapter 3.

1.4.1 Orientation

A strong orientation program for new hires is of the utmost importance to help new staff understand the day-to-day operations of their new workplace as well as promote a sense of community and unity within the group. There may be many types of orientation programs that are needed depending on the size of the research institution. Large groups may need to introduce institutional policies in the form of a welcome package or online training modules as well as departmental information in the form of a tour of the facility, standard operating procedures (SOPs), and specific study documents. It is also beneficial to take advantage of predeveloped training programs such as the International Conference on Harmonization or technical requirements for registration of pharmaceuticals for human use and other regional specific guidelines (e.g., Tri-Council Policy Statement 2 in Canada and Clinical Trials Regulations in the United Kingdom). It can be helpful to have a personnel binder in place to ensure that all staff have completed the required training and orientation material before beginning to work independently. ▶Fig. 1.1 shows an example of a “New Personnel Checklist” that can be adapted for your needs. It includes items such as SOPs, institutional orientation, contact form, and so forth.

1.4.2 Mentoring

Now that you have made the important decision of hiring a new team member and have oriented them to your clinical research team, it is time to develop a positive mentoring environment. This means having a transparent relationship with your new hire; therefore, they are aware of what your expectations are and how you will supervise them. This may mean for the first few months of a new hire’s employment to start the week with a list of tasks that are required and then following up at the end of the week to see how these tasks were accomplished. Or, it may mean partnering a new hire with an experienced team member to double check work until the new team member is comfortable with the procedures and workflow within your team. Having clear expectations of the work that needs to be accomplished will allow the new hire to not only feel included in the team but also have a sense of accomplishment for completing assigned tasks. Being direct with your vocabulary is also incredibly important to ensure that there is no discrepancy in the message that is being delivered. For example, saying: “This report is very important, please make it a priority and have it back to me as soon as possible” may mean to a new employee that you expect the report by the end of the day. For you, this may mean you need it back by the end of the week. Instead, saying: “This report is very important, please have it back to me by Friday at 5 pm” is much more direct and does not leave any room for interpretation. With that being said, having an open dialogue with your new hire will allow them to discuss with you the feasibility of your expected timeline. Additionally, being approachable with your new hire is incredibly important. Remember, investing your time and energy in a new hire will benefit the team long term. Another way to include your new hire in the team and to encourage an excellent team dynamic is to inform them of who to approach with various questions. For example, identifying who in your team is the expert on ethics applications or database development will allow the new hire to reach out to all team members to start to develop relationships with each person and to relieve some of the burdens from you. In smaller groups, you may be the go-to person for all inquiries. In this case, informing your new hire that you are there to offer support and build competence and not simply to correct all of their errors will show that you are trusting of their decisions and will ease some insecurity that new team members often have. Additionally, involving new staff early in team meetings, teleconferences, and meetings with key stakeholders in the research group will allow them to learn from the rest of the group and to help build confidence to share their own ideas and thoughts. A new team member is joining the group with his/her own experiences and expertise and it is important to respect different opinions and allow the newest team member an opportunity to share the ideas and solutions to problems that may arise. New team members may not have much to contribute in the early days, but active listening is a great way to learn the inner workings of the group.

Fig. 1.1 New personnel checklist example.

1.4.3 Performance Reviews

Regular performance reviews within the first year of a new hire’s employment can be beneficial for many reasons. It can allow you, the manager, to remedy any performance issues that arise immediately to prevent bad habits from forming. Performance reviews can also give the new team member an opportunity to share the experience with the team and to raise any concerns that they have. These performance reviews can be in many formats. For example, formal reviews with a written report at 3, 6, and 12 months can be reviewed by the team member and filed in the new employee’s personnel file and you can offer informal reviews monthly by having one-on-one meetings to discuss work performance. It is also important to consider more experienced team member’s feedback regarding the new hire. Other team members often work closely with the new team member and their input and thoughts should be considered. This will help the existing team members feel included and valued and will also help to resolve any internal conflicts that arise quickly and efficiently.

1.5 Communicating with Staff

Having exceptional communication within the research group is paramount to ensure the study runs efficiently, ethically, and without errors. Strong communication from the principal investigator is incredibly important. The principal investigator, who is ultimately responsible for the study, must be able to communicate what is needed for a specific study to the managing research coordinator who can then delegate to the rest of the team. Conversely, the research coordinator must be able to communicate to the principal investigator how the study is progressing, any action items the principal investigator needs to resolve, and any study problems or issues that arise. The research coordinator is responsible for ensuring that the rest of the team knows what is required of them to run a study and having an honest and open relationship with all team members will encourage junior staff to raise concerns, share innovative ideas, and feel as though they are part of the team.

1.5.1 Communication Strategies

A managing research coordinator that is accessible for day-to-day communication will again strengthen the sense of team and camaraderie within your research group. This can be achieved by checking in with your team members face to face if you are in the office, emailing the staff to inform them of your availability, and being accessible by phone if urgent issues arise. Additionally, weekly team meetings are an excellent way to ensure that all staff stay up-to-date with a specific study. They provide the team the opportunity to share milestones that have occurred over the last week and issues that have arisen. They also allow the team to be prepared for what is coming next and to delegate tasks appropriately. Furthermore, it is important for team members to understand processes beyond their specific role to encourage self-development and growth. A concern many have with weekly meetings is that they can often be time-consuming and it can be challenging to stay on topic. Running an efficient meeting comes with practice and a specific, detailed agenda. It is possible to run efficient meetings that are not a waste of time! Practice and consistent agendas will help promote a well-organized and efficient meeting. Another communication strategy is one-on-one meetings with each team member in turn. Although incredibly time-consuming, this method of communication does have its benefits. The research coordinator is able to ensure that each team member is meeting the deadlines and can discuss sensitive information in a private setting. Alternately, this approach can diminish the team dynamic and make individuals feel isolated and in the dark about study matters outside their direct role. Ideally, one-on-one meetings would occur quarterly or on an as-needed basis, with other communication methods taking precedence. In addition to meetings, it is important to be very clear when communication about a specific task that needs to be accomplished. For example, you may have a big picture idea to translate study material into many languages to introduce the study in various countries. Team members, specifically junior and inexperienced staff, will often need task-specific directions to accomplish this. A good leader will be able to share the big picture idea and work with the staff to facilitate it. It may be as simple as giving your staff a list of resources to get them started with a specific task. Setting your team up for success by being available and communicative about tasks with specific instructions will promote a sense of accomplishment.

1.5.2 Communicating with External Staff

Depending on the size of your research group, communication with external stakeholders can be an important aspect of the managing research coordinator role. Developing a good working relationship and a strong rapport with members from other teams is beneficial for all parties. It is important to remember when working with external sites (e.g., when collaborating with site principal investigators) that what you are asking of them is likely not their priority. Another research coordinator may be working on his/her own 10 projects and you asking him/her for an update on recruitment numbers may seem like a simple task, but the coordinator may need to speak with other people on his/her team to find this information. Being mindful of this reality and giving your external colleagues time and realistic deadlines can help strengthen the working relationship. Additionally, when external colleagues ask you for information or help, it is important to be transparent about your time and other commitments. Being open and honest about your expected timeline for completing the task will help to build a rapport with external colleagues and a trusting relationship. Keeping in mind the demands of other allied professionals’ time constraints will also help you stay organized and on top of tasks that you need others to complete for you. For example, working with the contracts office, ethics committee, statisticians, and so forth is a necessary part of clinical research and can often feel very challenging. Being respectful of their time, other job responsibilities, and offering realistic deadlines will make these interactions smoother and help to build strong working relationships.

1.5.3 Relationship/Team Building

Building strong working relationships within your team is also essential. As mentioned above, strong relationships with external colleagues will make tasks that can often feel challenging more rewarding. Using similar techniques within your group will benefit all team members. Understanding that your team has daily/weekly/monthly responsibilities when asking for additional tasks to be done shows that you are being empathetic and supportive, especially during times of increased work, such as grant writing and other high-stress situations. Team building is a term that is often seen as activities outside the realm of a normal workday that the entire group performs together, such as escape rooms or corporate picnics with games. These types of activities are often approached with a groan from the team rather than excitement. Instead of promoting extracurricular team building, incorporating strategies into everyday office life can be more beneficial in building relationships. For example, during a brainstorming session, employees may be hesitant to speak up for fear of their ideas being rejected. To remedy this, start the meeting by banning words or sayings that are negative (we have tried that before, that will never work), do not allow negative disclaimers (I have not really thought this through …), and encourage positive sayings (great idea, I love that). Additionally, assigning a humorous code word to be called out when these prohibited sayings are heard can bring a sense of levity to the session. Then, write down ALL of the ideas that are shared and assign them to individual team members to investigate further. Simple tweaks to what can traditionally be an uncomfortable meeting can build trusting relationships within the group.

1.6 Organization

Being well organized in your managing role can be beneficial not only to the study you are managing but also for your staff. Think about the managers and leaders you have encountered throughout your career. Were you more confident in the abilities of the person who was scattered and all over the place? Or, the person who was well organized and on the ball? I suspect most people prefer the latter. A manager who is organized shows the team that they can handle the responsibilities of the role and deal with any crises that arise. Being organized does not come naturally to everyone but with practice and some tools, everyone can improve own organizational ability.

1.6.1 Documentation

As we know, a clinical research environment lends itself to a great deal of documentation. Ultimately, the research coordinator is the gatekeeper of all documents and is responsible for version controls and ensuring staff have access to what they need. It is critical to ensure that information is shared correctly and without errors. Patient data, regulatory requirements, ethics applications, protocols, and grant applications are just a few of the documents that need to be organized. Depending on the size of your research group, the amount and types of documents that will need to be accounted for will vary. In larger groups with many projects, a shared server on the computer is a great way to ensure staff have access to all study material and access to specific folders (e.g., grants, personnel, and financial information) can be restricted to maintain confidentiality. Trackers that are kept on the shared server are an excellent way to organize grant and manuscript submissions (▶Table 1.1, ▶Table 1.2), personnel information, and other study-specific documents. In smaller groups, a binder system may be sufficient to stay organized. Whatever method of organization you choose, it is important to stay consistent and make organization a priority. Maintaining meeting minutes is also a great way to make sure that your staff know what tasks were discussed in the previous meeting and action items that still need to be completed.

1.6.2 Time Management

In addition to staying organized with documents, managing and organizing your time and your staff’s time will improve the efficiency of the team. Inexperienced and junior team members may need mentoring to learn how to prioritize tasks and responsibilities, while experienced staff will likely have a great system that works well. A respected manager will appreciate that no two people work the same way and will respect the way the staff complete tasks. Additionally, effective delegation is critical to ensure that your team members have appropriate work, and everyone is working toward a common goal. To successfully delegate, you must give clear expectations as to what the end result should be. Delegating the steps to complete the task can be inefficient knowing that everyone works differently but being open with the amount of support you will offer through the task will allow the team members to approach you if they run into challenges. Moreover, it is important to consider what tasks should be delegated and what tasks you should do yourself. For example, asking a team member to create a presentation that you will be giving may seem like a great way to free up your time, but phrasing and word choices are personal. Delegation of tasks such as these often end up with multiple revisions that are very time-consuming for the team member that you delegated to and for yourself to review the presentation again and again. Additionally, if you require a report to be completed in 2 hours, it may be inefficient to spend half an hour explaining it to a team member to complete. It is important to be aware of the tasks you are delegating, the amount of time these tasks will take to complete, and the level of detail required when delegating the task to junior team members. Finally, involving your team in the delegation process can help your team discover their strengths and weaknesses, and you can help them develop skills to complete tasks they consider a personal weakness. Another aspect of time management in a research group is organizing vacation requests and time off for employees. Allowing your team members to take time off when they would like to will help to create a positive work environment. Although it is not always realistic to approve all vacation requests, having a policy as to when people can take time off (e.g., based on seniority), and communicating openly with your team will make this process less challenging. Additionally, coverage for your team members while they are on vacation is of the utmost importance. Everyone needs a chance to recharge and having redundancy in your group will make vacation times and unexpected absences easier to manage. Ideally, everyone in your group should have at least one person that can handle any urgent issues that arise when they are not in the office.

1.7 Management Competence

1.7.1 Managing Up and Managing Down

A managing research coordinator has many responsibilities. Not only does the research coordinator need to manage her/his study and team but she/he also must have the foresight to anticipate the needs of the principal investigator. The term “managing up” can have negative connotations, but the ideas are valid. Often people see managing up as a way of self-promotion, but in the clinical research world, managing up to your principal investigator is essential to protect the research being conducted. Principal investigators are generally busy individuals with many responsibilities and it is the research coordinator that will inform the principal investigator when they are needed for research meetings and other research-specific duties. Managing up to your principal investigator by reminding him/her when he/she is required to submit reports, when grant deadlines are approaching, and with other study-specific information will ensure that he/she stays informed of all relevant information. Ultimately, the principal investigator is responsible for all aspects of a clinical study, even when delegating tasks; therefore, having a strong working relationship with your principal investigator will ensure that all information is shared appropriately. As seen throughout this chapter, the managing research coordinator needs to be able to manage down to the team. There have been many strategies that have been discussed to help build a team and increase managing competency, but ultimately, a great manager leads by example. Remember to practice what you preach and not expect your staff to complete tasks you are not willing to complete yourself. Be trustworthy. If a team member comes to you regarding personal issues or challenges within the group, treat the information confidentially and be as empathetic and helpful as you can. Be a strong mentor. Continue to develop your leadership ability by sharing your knowledge with your team and build them up into leadership roles. Having a team with strong confident leaders will create an efficient team.

1.7.2 Professional Development

Continuing to learn throughout your career will make you an exceptional manager. Often people are placed into management positions with no training and are expected to excel. Learning to manage people with various personalities can be challenging and professional development classes can be of great assistance. Taking professional development courses on dealing with difficult people, active listening, and providing feedback can help you understand how you are interacting with your team and give you strategies to make these relationships better. You often hear people being praised as natural-born leaders, but you do not hear the same about managers. Being an excellent manager requires you to hone your skills and be willing to change and adapt to your team. You are not always going to make the right decision and manage your team in the most efficient manner, and that is okay. If you are open and honest with your team and are willing to accept help from others, continue to better yourself, and encourage your staff to do the same, your team will benefit. Encouraging your staff to take part in professional development, specifically in leadership and management skills, will show that you have confidence in your team to become leaders/manager and will create a cohesive team.

1.8 Conclusion

Understanding various leadership styles and adopting strategies to develop a strong team dynamic will make you an exceptional manager. Building your emotional intelligence and being empathetic to your team’s needs will increase the efficiency and success of your team. Additionally, learning how to organize your time, your staff’s time, and various documents will allow each team member to be productive and work at the best. Finally, continuing education and professional development will allow you to continue improving your managing ability and will ultimately benefit the field of clinical research.

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