During our recent webinar, Competency-Based Approaches to Staff Hiring, Management and Advancement, Beth Harper, President of Clinical Performance Partners, Inc., and the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP), explored the theory and practice of competency-based approaches for hiring, retaining and helping clinical research staff advance. Here, she answers attendee questions about clinical research certifications, competency evaluation, experience levels and more.
I would not want to see licensure replace certification. Do you feel the difference between the two is significant?
This is a great question. First, it’s important to revisit the definitions and differences between licensure and certification.
Licensure is a mandatory process by which a governmental agency grants time-limited permission to an individual to engage in a given occupation after verifying that he or she has met predetermined and standardized criteria. Currently, there are no licensure requirements for clinical research professionals.
Certification is a voluntary process by which a non-governmental entity grants a time-limited recognition to an individual after verifying that he or she has met predetermined and standardized criteria. This is voluntarily pursued and provided through a professional organization, after completing more training and testing requirements and in many cases, after completing minimum of two years on-the job experience (in the case of ACRP requirements).
Licensure is intended to ensure the public that a person is competent to practice in that profession (or at least validates someone has acquired the basic knowledge required for safe practice). Generally, licenses are needed to regulate an activity whose incompetent execution would be a threat to the public. I think all could agree that improperly executed clinical research could harm the public. Without licensure or some type of equivalent entry-level knowledge exams for clinical research professionals, there is a greater risk for inconsistencies and poorer quality in the conduct of clinical trials, all which could lead to the potential for harm to the individual subjects and the public at large.
So, for me the question is not really whether licensure will replace certification, but the questions are more around the following:
- Whether governments should and will start instituting licensure requirements for clinical research professionals
- Whether, as an industry, we should establish minimum entry-level knowledge requirements and/or demand that certain types of clinical research professionals get certified in order to perform specific roles and tasks in clinical research
- Whether the clinical research industry should be more proactive to self-police ourselves to expect at least minimum standard requirements before government agencies start mandating licensure
What training competencies should be used when clinical research coordinator (CRC) positions are filled with employees who have higher levels of education than is necessarily required for the CRC position? For example, if they have a master’s degree but limited or no research coordinator experience.
This is where a structured and leveled competency assessment tool can be particularly helpful. By structured, I mean a more systematic set of guidelines that allows an individual to self-assess themselves across the competency domains and job-specific requirements. Similarly, a manager can do an assessment of the individual’s competencies to identify the gaps. By leveling, I mean distinctions of competency requirements for entry-level through more senior level positions. This is the approach that ACRP took when developing our CRC competency guidelines. In the case of someone with higher education degrees, or prior experience, they may score at higher levels of competency in certain domains (such as leadership and professionalism, teamwork and communication) but have more gaps with technical skills and knowledge in other domains (such as GCPs, study management and so forth). By following a structured approach to competency assessment, it is easier to identify the gaps so that targeted training is provided for the deficient areas.
Does the methodology of self-assessment and scheduling time with your manager to conduct an assessment of your competency levels introduce gender or discrepancies?
Actually, one of the values of a more systematic and structured approach to competency definition and assessment is that it enables a more objective, unbiased and transparent approach for both the individuals and managers. This type of process makes it very clear what the expectations are for promotion and advancement and allows individuals who are on a trajectory for faster advancement to demonstrate their competencies rather than argue for advancement based on job tenure alone. While some individuals may progress faster to advanced roles, by really mastering certain competencies in comparison to their peers, all understand how they are being evaluated and what it takes to advance, thereby reducing promotion practices that may be more subjective in nature. So, in my view, this methodology actually reduces biases and discrepancies.
Often, pharma equates higher competency with higher cost for personnel. How do we get industry buy-in for competency-based hiring and promotion?
While I wish I had an easy answer for this, I fear that this is an ongoing education process. At ACRP we are aggressively trying to educate the industry at large about the competency definitions and concepts as well as the challenges and issues associated with the lack of competency standards. That is a first step; getting everyone on the same page with regard to competency-based nomenclature. From there, we are also trying highlight the risks that are associated with the lack of competency standards. As clinical trials get more complex, it behooves everyone to ensure those individuals conducting these trials are performing at a level of efficiency to ensure subject protection and data integrity. Helping all stakeholders to connect the dots between competency-gaps and the potential risks for the subjects, protocol compliance and data quality should ultimately lead to a recognition that competency and associated quality come at a premium.
Are there ways to be involved in some of these initiatives even if your organization is not participating?
Absolutely! From ACRP’s perspective, we always welcome volunteers to the task forces working on the various competency projects. Please feel free to contact me (email@example.com) at any time and I can share more about the specific projects. Beyond that, take a look at what other institutions are doing and how you can build upon and start your own organization-specific projects. Along those lines, ACRP sponsors an annual workforce innovation award to recognize workforce advancements. The call for submissions usually takes place in the summer following the ACRP annual conference which takes place in April. We look forward to showcasing the five finalists at this year’s annual meeting in Nashville.
Want more answers?
Watch the free, on-demand webinar, Competency-Based Approaches to Staff Hiring, Management and Advancement, to learn more about competency-based approaches for hiring, retaining and helping your clinical research staff advance. Watch the recording today!