Bhandari / Van Lieshout The Coordination of Clinical Research

A Handbook for Research Coordinators
1. Auflage 2020
ISBN: 978-3-13-258254-5
Verlag: Thieme
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 340 Seiten, ePub

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.

Zielgruppe

Ärzte

Autoren/Hrsg.

Bhandari, Mohit

Van Lieshout, Esther

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Chirurgie Orthopädie- und Unfallchirurgie

Inhaltsverzeichnis

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!
Part II What Every Research Coordinator Needs to Know
5 What is Evidence-Based Medicine?
6 Randomized Controlled Trials
7 Observational Studies
8 Surveys
9 Qualitative Studies
10 Principles of Good Clinical Practice and Research Conduct
Part III From Idea to Study Start-Up
11 Principles of Grant Writing: Tips for a Successful Experience
12 Dollars and "Sense": A Guide to Research Finances
13 Maintaining Records and the Trial Master File
14 Ethics Submissions
15 The Basics of Research Contracts
16 How to Start-Up a Study
Part IV Study Execution and Close-Out
17 Screening and Recruiting Participants
18 Obtaining Informed Consent
19 Collecting Data: Paper and Electronic Data Capture Systems
20 Follow-Up: Why It Is Important and How to Minimize Loss to Follow-Up
21 How to Close Out a Study
22 Knowledge Dissemination: Getting the Word Out!
Part V Advanced Principles of Research Coordination
23 Regulatory Trials: Key Differences from Standard Trials
24 How to Survive a Site Audit
25 Monitoring in a Clinical Study: Why and How?
26 Managing Large Studies: Organization and Committees
27 International Research: Challenges and Successes
Part VI A Coordinator's Toolbox
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

Leseproben

1 Leadership and Management: The Principal Investigator and Research Coordinator

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.

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 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...