Leadership Strategies for Building and Sustaining Effective Clinical Research Teams: A Personal Reflection

Grace Wentzel, CCRP, CHRC

Grace Wentzel, CCRP, CHRC, director of Clinical Research Services for The Research Institute at Nationwide Children’s Hospital in Columbus, Ohio.

Clinical Researcher—December 2017 (Volume 31, Issue 6)


Grace Wentzel, CCRP, CHRC

[DOI: 10.14524/CR-17-0039]

I will never forget the moment I discovered my passion for research. I was 26 years old, working as a psychometrician at a children’s hospital in Columbus, Ohio. I had just finished a developmental assessment with Garrett*, a 6-month-old baby boy.

I had worked with Garrett a few months earlier; he was so sick that he barely engaged with me. This time was different. When I walked in the room, he looked at me with big blue eyes, smiled, and was fully interested in who I was and what I was doing. As I carried him into the exam room after his assessment, I heard his grandmother tell the infectious disease study investigator, “Thank you so much for saving my grandson’s life. If it wasn’t for you and this research study, he wouldn’t be here.”

I have been involved in pediatric clinical research for 23 years, and am fortunate to have many stories just like Garrett’s that have inspired me, fueled my passion, and encouraged me to lead others.

What’s in a Word?

Ask 10 people what “great leadership” is, and you are likely to receive at least eight different answers. Some would define great leadership by an ability to innovate, think strategically, and get results. Others may define it as an ability to listen, empower others, and do the right things at the right times.

A person is not born a great leader; it is a journey during which they develop and hone their skills over time. I would argue that leadership style should match the purpose of the field—the leadership style needed in healthcare is not the same style needed for Amazon.

Regardless of the field, great leaders must be passionate. Passion is the key to a fulfilling career, no matter what path you choose. Your passion will inspire others.

The Research Environment

Clinical research is a complex, stressful, and ever-changing arena in which to work. However, knowing that you are involved in finding the best treatments, providing the best options, and giving families hope is a powerful purpose, and one that encourages people’s passion.

In my leadership journey, I have learned open-mindedness and humility are critical; I do not profess to have all the answers, and I attempt to surround myself with team members who have strengths I do not have. The key to building a strong, sustainable, effective team is to choose people who share your passion and who understand and embrace the purpose of clinical research. Encouraging independent thinking, accountability, personal growth, and having FUN are critical to staff retention.

Choosing the “Right” People for Your Team

Choosing the right people for your team is the most difficult task a leader faces. Clinical research is a field with which many people have little to no experience when they interview to join it. It is not a field where everyone can be successful.

Clinical research requires someone who loves a challenge, is a continuous learner, and is flexible enough to adapt to shifting priorities. It takes someone who has great attention to detail, but who can also see the big picture—someone who is energized, not paralyzed, by stress, and someone who is self-motivated and resourceful, but not afraid to say, “I don’t know; I need help”; that is the type of person that will thrive in this field.

How can you discern in a single, short interview if a candidate possesses the attributes most valued by your team? Candidates may have the technical skills required, but do they possess the other skills that are critical to success in a clinical research environment—skills that you can’t see on a résumé?

In an effort to increase our chances of choosing the right person for an open position, my institution, Nationwide Children’s Hospital, utilizes a behavioral interviewing process that involves multiple layers and panel interviews to illicit how the candidate would react in specific situations. If a potential clinical research nurse (CRN) describes the perfect day as one in which all of the items on the to-do list are checked off, or the thing that is most bothersome is when things are not completed from the to-do list, then a CRN position is likely not the right job for that candidate. Training a new CRN to independently handle investigational drug studies can take more than six months, so the better an organization can determine a candidate’s suitability for the position up front, the more likely he or she is to be retained through the full training period and beyond.

For candidates with low suitability for a CRN-type position, a great deal of frustration may develop when they realize that the list keeps growing and the studies never seem to end. Experienced clinical research professionals know that you must be able to change how you define “complete” to feel a sense of success.

Candidates are strongly encouraged to shadow a person in the position for which they are interviewing, so they can experience the position firsthand. Allowing candidates to experience the day-to-day responsibilities gives them a better understanding of the job requirements.

An interview system that fosters an immersion in the field can also help to avoid high turnover. The training process is lengthy, and therefore highly dependent on retention rate of staff.

Retaining the “Right” People

At my institution, the Clinical Research Services (CRS) unit offers centralized infrastructure support for investigators who want to conduct clinical research. The CRS team comprises more than 40 people who handle institutional review board/regulatory affairs, feasibility/financial management matters, and training/compliance issues, as well as staff serving as program managers, CRNs, and study coordinators—all sharing the philosophy that everything we do impacts the life of a child. We embed this purpose into our interviewing process, onboarding, departmental expectations, and daily operations.

The new hire process starts with assigning a mentor to work with the new team member throughout a 12-week, competency-based onboarding period. It is crucial to set clear team expectations during these first weeks. Accountability must be a theme in a clinical research department—accountable to the participant, the principal investigator, the team, the science of the study, the regulations, and to oneself.

As a leader, achieving the right balance of skills on your team can be tough. Do you have someone on the team who is great with recruiting participants, but creates tension within the team? Does someone complete the study visit perfectly, but then fail to complete the case report forms in a timely manner? When is it time to have the “to be successful in this position, you must be able to balance both study visits and timely completion of paperwork, and you are not meeting expectations” discussion?

Clearly defined expectations that are continuously reinforced by every member of the team create an environment that will lessen a leader’s need to redefine the expectations for an individual. Thus, every member of the CRS team is expected to be a leader. A monthly leadership series was developed that involves reading articles, books, and meeting for an hour in smaller groups, covering topics such as:

  • Defining a Leader
  • Effective Communication
  • Managing Conflict
  • Managing Change
  • Optimism in Leadership
  • Shadow of a Leader
  • Work/Life Harmony
  • Challenging People
  • Staying Engaged
  • Emotional Intelligence

The leadership series has been well received; it is an opportunity to share experiences and viewpoints, learn about peers, hear alternative perspectives, and develop strategies for dealing with difficult situations and people. As the director for the department, it has provided me with invaluable insight into ways to continue to inspire my team, to encourage their growth, and to fuel their passion.

Our departmental culture values being at our very best, so that the children and families with which we are privileged to interact have a fantastic research experience. Transparency is part of all our interactions with each other; coaching and mentoring are strongly encouraged and common. Feedback is welcomed, and occurs at all levels to ensure that those in management roles are also displaying the expected behaviors.

A flexible environment that supports continued personal growth has proven to increase retention rates for our department. Growth can occur within the department with additional responsibilities or a different position; it can also occur outside the department with continued education.

In our department, two clinical research coordinators have completed nursing school and are now CRNs. Three administrative assistants have moved into positions involving regulatory, feasibility, and project management issues. One project manager has shown an interest and aptitude for marketing, so she has taken over recruitment/marketing responsibilities. A CRN developed and teaches an institution-wide, four-hour class on protocol adherence.

Identifying when team members have more to give and recognizing hidden talents often create growth opportunities which, in turn, show how much they are valued by the organization.

Clinical research study management and administration can be incredibly challenging and stressful, so last (but not least), infuse fun whenever and wherever you can. Celebrate successes with ice cream parties, recognize birthdays with dessert, schedule potluck breakfast on Fridays before big football games, play balloon volleyball in the staff hallway, take a yoga or zumba class as a group, let everyone leave an hour early to get a jumpstart on the weekend, get pizza after work once a month, volunteer as a group to make care bags for parents who stay at the Ronald McDonald house, or plan a day at the zoo.

Find ways to encourage the team to laugh during the work day, de-stress over the sponsor who just sent 100 queries, and have fun as a team—inside and outside the work setting. This is a great way to reduce stress and also encourage team members to get to know each other personally. We have found that knowing each other’s personalities and caring about what is going on in someone’s life encourages team bonding, reduces false assumptions, and ultimately decreases dysfunction within the team.

Leadership is not about being a boss; it is about selecting the right people for the team, providing them with the tools and resources they need to be successful, setting clear expectations, giving guidance, and facilitating their growth. They will do the rest on their own.

There have been many challenges in the two decades I have been in clinical research administration; however, my most rewarding moments as a leader are when I see a member of my team flourish in a new role, excel with a project they have been given, and lead someone else with excitement and passion. Those moments inspire me to face administrative challenges head on, refuel me in difficult personnel situations, and sustain my passion as a leader, so that we can continue to find the best treatments, provide the best options, and give families hope.

*Name of child was changed to protect his identity.

Grace Wentzel, CCRP, CHRC, (grace.wentzel@nationwidechildrens.org) is director of Clinical Research Services for The Research Institute at Nationwide Children’s Hospital in Columbus, Ohio.