Guest Editor’s Message: The Evolution of Clinical Research Careers

Paula Smailes headshot

Paula Smailes, RN, MSN, CCRC, CCRP

Editor’s Note: This is a preview of Clinical Researcher—December 2017 (Volume 31, Issue 6). The full contents will be posted online December 12.

Paula Smailes, MSN, RN, CCRC, CCRP

[DOI: 10.14524/CR-17-4044]

Our clinical research careers are not stagnant. They change, but what makes them change? Do we take steps as individuals to do it ourselves, or do external forces push us along?

Career evolution is the theme of this issue of Clinical Researcher. We may travel down paths where our careers develop in ways that we never thought possible. However, they may do the opposite. How can we keep our careers headed in the right direction when they aren’t going as planned or when we need to feel more fulfilled?

Starting the Journey

This year marks the 15th in my clinical research career, and so much has changed during this time. I confess, at first I never planned to enter the clinical research industry, and then when I did decide to take the plunge, I had no idea how to land a job there. I just knew that it was a place I wanted be.

My first job interview, I didn’t get the position. For the second one, I took a lot of chances. I applied for a research job in an academic medical center out of state, where I could capitalize on what I did have (education and clinical experience), not what I was lacking (research experience). That paid off!

Off I moved, eight hours away, to an unknown land to gamble on the career I thought I wanted.  My instincts were correct, though. I loved it! I got used to the crazy, rapid enrollment periods, the queries, and the stacks of paper charts in my office like towers all around me. I gained confidence in what I was doing. I quickly absorbed the jargon and processes. I solidified my place in this niche and then I started climbing the ladder.

Professional Development

Once you land that dream research job, it’s not uncommon to wonder, “What’s next?” Lots of professions have career ladders, but they aren’t always easy to come by in all areas of the research enterprise.

For an article in this issue, I joined forces with research nurses Holly Bookless and Carrie Blumenauer to discuss how clinical ladders, which are common for hospital-based nurses, can be transferred to research settings. There is value in ladder programs, and the rewards are apparent in terms of professional development for employees and organizational enhancement for employers.

After a few years in the industry, I remember being encouraged to become certified. I waved that off. While I loved my new role, I hadn’t completely committed to it. Ultimately, I took certification tests to become a Certified Clinical Research Coordinator (CCRC®) through ACRP and a Certified Clinical Research Professional (CCRP) through SOCRA. Little did I know that becoming a CCRC and a CCRP would make me extremely valuable in the industry.

Certifications display your competencies and are a great means of professional development. They show just how valuable your knowledge is. I encourage anyone who is ambivalent to become certified. You will see the rewards of doing so.

Work/Life Balance

As the years rolled on, I got married, I had two babies, and then my parents became terminally ill—first my dad, then my mom. During this time, I needed better work/life balance to match the increasing needs of my family. Could my research career give me that when my personal life was demanding it?

I wondered how my career could evolve as my life had. Just as I was wondering that, I reached the low point in the career I loved. I lost my job. The clinical trials program I managed was being phased out. That served as a guidepost to force me to a path I wouldn’t have otherwise taken. It was the path that led to the clinical research position that would give me the work/life balance I needed, while pushing me to get out of my comfort zone and grow professionally. When one door closed, another door opened.

As I thought about articles to solicit from others for this issue, I also considered that work/life balance. Can we have our research careers and a personal life that keeps us fulfilled?

Back when my family demands were so high, I wondered if I could be my own boss and independently consult in the industry. As I was throwing that idea around, I had many conversations with Nicole Tesar about her path to becoming an independent research consultant. I asked her to write for this edition about her journey, along with words of wisdom, for anyone considering being their own boss. She offers great insight for all aspects of being a consultant.

Competencies in the Workforce

The onset of technology has moved our research environment and expectations of research roles to a whole new level. It has had many positive effects, such as more efficient, timely reporting of data. Simultaneously, it could be argued that we actually have to work harder to keep up with industry demands that force us to produce data quicker. At the intersection of technology, education, and clinical research is where I found my current position, where I’ve been for almost five years.

Technology has demanded a new skillset for the research workforce, and this is where professional competencies enter the picture. In 2014, the Joint Task Force (JTF) for Clinical Trial Competency published its seminal piece on defining the standards for professionalism in the research industry.1 One of those competencies covers data management and informatics for how data are acquired and managed during a clinical trial. These competencies are enjoying increasingly more exposure in the industry.

In this issue, a multi-institutional group of authors led by Jessica Saunders and senior author Rachel Stanley describes a pilot study done to evaluate the onboarding process to see if it adequately addresses the JTF domains for professional competencies. The authors found that while clinical research coordinators understand the importance of the JTF competencies, many of them felt less than competent to do their job.

Recruitment and Retention

The importance of having a trained workforce in clinical research ultimately impacts the integrity of clinical research. Also in this issue, to further ensure that onboarding is effective and streamlined for new hires, Rebecca Brouwer and colleagues from Duke University discuss the implementation of a large effort to introduce a competency-based framework based on the JTF competencies. Their goal is to recruit, retain, and train to engage staff in a transparent initiative that standardizes job classifications and provides new opportunity for advancement in their workforce.

Further, Grace Wentzel’s article shows what drove her to clinical research, and up the ladder to a leadership position in the profession. She covers many important topics, such as recruiting and retaining a solid workforce, recognizing the desired attributes of leaders, and establishing a positive clinical research culture.


Whether you entered clinical research intentionally or by accident, the path is rewarding. Remember that our careers are a journey, not a destination. I hope the contents of this issue provide insights for your own career and where it may lead next. It is my honor to be the guest editor of this first-ever electronic-only edition of Clinical Researcher. I hope you enjoy it!

Paula Smailes, MSN, RN, CCRC, CCRP, ( is a member of the ACRP Editorial Advisory Board, a senior training and optimization analyst for clinical research at The Ohio State University Wexner Medical Center, and a visiting professor with Chamberlain College of Nursing.


  1. Sonstein SA, Seltzer J, Li R, Jones CT, Silva H, Daemen E. 2014. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clin Res 28(3);17–23. [doi:10.14524/CR-14-00002R1.1]