Our team believes that in order to minimize the risk of variance in research conduct quality it is necessary to prioritize workforce development and the standardization of competence and career paths. While it is true that excellent technological solutions are being developed through initiatives of various kinds, our team is focusing on standardizing and enhancing the competencies of the people who are conducting trials at the grass root level.

There is no straightforward path to becoming a clinical researcher. Most of those who eventually take up the role acquire the knowledge and skills needed as they progress through various stages of their career, the organizations that employ them each have their own training programs. Consequently, there is a lot of variance in the processes, conduct, and competence of the workforce that these different paths produce. This is not ideal for maintaining research quality.

For evidence of the fact that the current approach isn’t working, look at the findings of the US FDA (Food and Drug Administration). Our team has put in place innovative initiatives designed to promote excellence in clinical research through improved standardization in workforce development and improved clinical trial quality.

We are playing a key role in the development of clinical research professional competences in cooperation with a multidisciplinary and multi-stakeholder representative body. Our mission is aligned with theirs, and that is to harmonize and align core competencies for clinical research professionals into a single set of standards that reach the highest level possible.

Together with this group we have adopted eight core competency domains for clinical research professionals with the goal of honing them and promoting their adoption throughout the industry.

It’s been apparent for some time that there is an insufficient level of knowledge, skills, and abilities within the CRA workforce. Core competencies are required for entry-level clinical research associates (CRA). The CRA Workforce Development Task Force, convened in 2015, includes representatives from several contract research organizations (CRO), and their sponsors.

There shortage of CRAs in the workforce has resulted in CROs and their sponsors fighting to retain CRAs as turnover has increased, as well as large and costly remuneration schemes. Despite the shortage and therefore the high demand, the knowledge and skills gaps remain, so the battle is for a high turnover rate of CRAs with high salaries, who are not in fact sufficiently skilled and experienced.

One of the reasons for the shortage, it is believed, is the requirement for two years of experience, a requirement that is considered more important than actual competence. The insistence on this calendar-based requirement discourages some CRAs who may well be competent but have not yet completed the fixed number of months in the workplace. The industry needs to improve its training mentorship of CRAs to meet the growing demand.

In contrast, an 8-week CRA Onboarding program that was delivered to a global pharmaceutical company resulted in a retention rate of 93% of the CRAs that participated in the program. They also reported that there were significant improvements in operations.