August 13 2021
Written by Alison Ivey, RN, MS, MBA, OCN, CCRP, Administrative Director, Clinical Research Office of the UF Health Cancer Center
Hi, my name is Alison and I have been in oncology research for almost 15 years now. While I was very lucky to have been exposed to the world of clinical trials as part of coursework for my nursing degree, I know that I am an exception to the rule. Most of my colleagues, and I am guessing many of you reading this, entered our profession without any formal training in the field and had to learn everything on the job. The quality of that onboarding often varies wildly dependent on the structure of the organization, available mentors and the individual’s learning style. On top of that, we have to navigate an increasingly complex research, compliance and regulatory environment that is only compounded by the intricacies of oncology care. Given these realities, it is not surprising that turnover rates for clinical research staff, coordinators specifically, are noted to be upwards of ~30% according to a 2020 publication by Stroo et. al. [1]. One can imagine that we can collectively do a better job of setting our new (and experienced) research staff up for success from the very beginning.
In 2013 a group of stakeholders representing a wide variety of research interests and practice settings converged in an effort to distill a number of practice standards down into one set of overarching competency guidelines. The group, known as the Joint Task Force (JTF), recognized that standardization was necessary to accomplish a number of important things in our field. First and foremost, the JTF wanted to address the training gaps identified within the work force. As noted previously, most training occurs on the job and, except for a few topics such as Good Clinical Practice and Human Research Protections, there are no uniform training standards. These gaps leave us vulnerable to unintentional breaches in data integrity and data safety. That said, this framework can now serve as the foundation for comprehensive research education curricula across personnel types and disciplines. Furthermore, this tool is very flexible in that it can apply to individuals of all experience levels. That means we can use it as a yardstick to measure our professional growth, identify areas where we need additional support and highlight those where we can serve as subject matter experts. Having solid professional benchmarks is vital to ongoing professional development which is very closely linked to job satisfaction and mastery [2].
Beyond the lack of uniform training, there is no single entryway into clinical research nor are there any certification or licensure requirements for research coordinators/associates. Theoretically, this means clinical research still has a little way to go in terms of professionalization. Sonstein and Jones [2] do a great job outlining the hallmarks of “professionalized” occupations in their JTF publication. They note that having a standard set of competencies is actually one of the required characteristics of a “mature profession”. Therefore the development of this framework is helping to propel this discipline we have come to know and love further forward.
The JTF research competency framework incorporates 48 competency standards distributed among 8 primary competency domains. The framework covers a variety of themes from scientific concepts and research design all the way to teamwork and communication. Each competency standard is accompanied by descriptions of the knowledge, skills and abilities held by individuals at the fundamental, skilled, and advanced levels. These descriptions are then supplemented with examples that can further assist with competency assessments. For example, competency 6.1 focuses on understanding the role of statistics and informatics in clinical studies. The framework outlines that individuals at the fundamental level have a basic understanding of principles such as randomization, sample size, adverse events, analysis, and results while those who are skilled should be able to articulate how the statistical plan is connected to the analysis of study endpoints. Advanced individuals would be those with specialized training in statistics who are able to develop a statistical analysis plan [3]. While we don’t necessarily expect everyone to be able to rise to an advanced level in all areas, the framework does a nice job illustrating the depth and breadth of knowledge across clinical research. The framework can also orient research professionals of all stripes to the key concepts that are so critically important for us to grasp to produce high quality, ethical, and compliant work. After all, it is what we owe to our research heroes, our patients.
So how can you deploy these in real life? At the University of Florida we developed a multi-tiered approach to incorporating these research competencies into our operations. First, we assessed learner needs and then developed a spiral curriculum to integrate these concepts into multiple layers of our organizational fabric. We have the framework embedded into our job descriptions, orientation materials, ongoing professional development, and evaluation processes. We have all staff complete a self-assessment and identify their current proficiency level for each competency with managers also completing an independent assessment. These assessments are done every 6-12 months with progress tracked and goals for professional development established. We have an ongoing monthly educational series with rotating topics that we tie into framework concepts. A future direction for us is to develop a library of scenario-based assessments to deepen our ability to assess application of concepts to real-world situations. We didn’t build this structure overnight, and neither will you, but investments made into empowering our research professional will pay significant dividends without a doubt.
- Stroo M, Ashfaw K, Deeter C, et al. (2020). Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. J Clin Transl Sci.
- Sonstein SA, Jones CT. (2018). Joint Task Force for Clinical Trial Competency and Clinical Research Professional Workforce Development. Front Pharmacol.
- Join Task Force for Clinical Trial Competency. Domains and Leveled Core Competencies.Retrieved from https://mrctcenter.org/clinical-trial-competency/framework/domains/#1547844219073-b5a5ecb3-989f