One of the greatest challenges facing the clinical research enterprise today is ensuring that a qualified, competent workforce is available to carry out its activities. Those of us already working in clinical research know that the downstream effect of having a highly qualified team is bringing new products to market quicker. The role of the clinical research associate (CRA) or monitor, like so many others in the industry, is challenging to break into, and one reason is the high standards set by employers for job entry.
An innovative approach to hiring new entry-level CRAs needs to be created—an approach that would fill the business need and give intelligent, motivated people a chance for success in the industry. Once new staff have gained experience, thoughtful measures must also be taken to continue training and professional development that ensures ongoing career success.
Getting in the Clinical Research Door
As an independent CRA, I have received LinkedIn messages, phone calls, and e-mails from many individuals looking to break into the clinical research industry. Ultimately, what they are looking for is a clear cut formula for getting their foot in the door without having direct experience. There are individuals out there with potential to be valuable assets to an organization, but they need an opportunity. Possible routes into the clinical research arena include networking, volunteering, and internships,1 however, there is no prescribed route for CRAs.
An arbitrary requirement for CRAs to have at least two years of experience is still in place at most contract research organizations (CROs) and sponsor companies. This raises the question: To what extent are employers valuing clinical research credentials/education, and how do the employers validate that individuals with these credentials are superior to those who do not have them? Conversely, how do job seekers find those particular companies that do value them?
To help point CROs and sponsors in the right direction, in 2013 the Joint Task Force (JTF) for Clinical Trial Competency was formed to develop competencies and skill requirements for the clinical research professional. Eight competency domains are highlighted in the JTF’s projects, including scientific concepts and research designs, ethical and participant safety considerations, medicines development and regulation, clinical trials operations (Good Clinical Practice [GCP]), study and site management, data management and informatics, leadership and professionalism, and communication and teamwork.2 The goal of this group was to align both skill and competency requirements for the industry professional.
It is not uncommon for companies to want a mix of skills, degrees, and general competencies for their CRAs. For the beginner CRA, the challenge becomes how to demonstrate skills and competencies despite a lack of prior work experience. As an industry, we have an obligation to bridge the gap between the inexperienced and seasoned CRA. One possible solution to this may be an Apprenticeship Program Model.
Apprenticeship Program Model
By utilizing apprenticeship as a workforce development strategy, an organization can promote successful outcomes for both its business and job seekers in a manner that helps it find and retain skilled workers with desired traits. Apprenticeship has been shown to be an effective solution for many federal- and state-regulated industries.3 Research shows that, through an apprenticeship program, companies have been successfully able to recruit, train, and retain highly skilled workers.4
The clinical research enterprise has all of the following challenges, which make it ideal for an apprenticeship model:
- Jobs for which it is difficult to find workers with the right skills
- Positions with high turnover
- Challenges helping workers keep pace with industry and technology advances
- Difficulty in attracting new and diverse talent pools
An Apprenticeship Program Model for CRAs would involve a lower pay rate/salary initially, on-the-job training, and low-risk task assignment.
The lower pay rate/salary at the onset lends to less financial burden on the organization. If the apprentice is willing to accept lower pay, the exchange would be the opportunity of a full-fledged job upon successful completion of the program.
Meanwhile, the program is comprised of a mix of classroom training, online modules, and one-on-one training with an assigned mentor. In this program model, the apprentice must pass ongoing skills and knowledge testing.
Finally, low-risk tasks would be assigned as the would-be CRAs learn more about their future role. Examples of potential low-risk tasks include taking meeting minutes during a team teleconference or organizing and filing of Trial Master File documents.
An apprenticeship program essentially involves “You do the job, and then you get the job.” Candidates would begin a six-month clinical research apprenticeship, spending one-half day per week on a site visit with a more senior CRA in order to further develop core skills and observe interaction with site staff. Once hired as a CRA, the former apprentice should successfully move upward to a higher level role over time (see Figure 1*).
The senior CRA position involved in such a program holds mentoring responsibilities and a decreased site load. Thus, an apprenticeship program incentivizes a potential employee with the opportunity of a job at the conclusion of a successful apprenticeship, as well as providing an opportunity for the senior CRA to grow and add new leadership skills.
However, as no training and development model is perfect, what happens if the apprenticeship program is not successful? What if apprentices decide the CRA role is just not for them? Furthermore, what happens if they are unable to meet the benchmarked requirements of the role?
One important step to reduce such risks is to ensure that the apprenticeship program is long enough. Perhaps the candidates need longer than six months to meet the required milestones. In the case of the apprenticeship model, it is critical to evaluate learned skills frequently to ensure those preset benchmarks are being met. If not, an extension of the program may be required.
Meanwhile, what if candidates decide they no longer wish to pursue the role of a CRA? If an individual has already invested time in a program, and the company has invested in training them, one positive outcome may be that while the CRA role might not be a good fit, perhaps another role can be identified as being of more interest. Part of a solid apprenticeship program would be the understanding of cross-functional roles within clinical research. If a candidate feels that his or her interest has shifted to one of those roles, the CRA apprenticeship may end; however, the potential for a different development plan could be considered to provide more exposure to the alternate role.
While the Apprenticeship Program Model represents a viable option for the novice CRA, other pathways exist to help facilitate this transition. A multiple-mentor workforce program would allow for an apprentice to be exposed to different work styles and personality types. In this model, the candidate would have mentors who are subject matter experts in specific cross-functional areas (e.g., data management, site management, therapeutic area training).
A learning and personal development model treats people as individuals, targets both traditional work skills and knowledge, and includes whole-person development—not just transference of skills. This model would have a secondary focus on assisting employees in identifying and achieving their own personal potential.5 Regardless of which route is taken, the presence of a formal program is essential for success.
Training and Development for Existing CRAs
As a CRA begins to gather experience, an ongoing training and development program is necessary. This not only shows that an employer is investing in the CRA’s future, but training ensures that employees are knowledgeable in the ever-changing landscape of the industry while supporting a career path for them.
Training and development of a successful CRA workforce involves a three-step process (see Figure 2*). The first step is skilling—the basic teaching of a required skill. This initial step typically involves a structured orientation program, including training on company standard operating procedures (SOPs). SOPs standardize the required skills, and are updated frequently as regulations and company expectations evolve. SOPs ensure that the CRA is, and remains, properly qualified and trained for job roles for which he or she is made responsible.Once skilling is established, the next step is reskilling, which involves re-teaching the skills that change or evolve.Lastly, the third step is upskilling—the concept of teaching and training employees beyond their current role to position them for the next role.
Developing Soft Skills
Beyond the challenge of creating and maintaining a robust training curriculum, how best to train on soft skills is a matter to consider. Interpersonal communication and executive functioning are critical in the role of the CRA. This role involves interaction with both external partners (site staff) and internal partners (in-house team members).CRAs often may have the basics of the communications skill set, but lack the personality it takes to balance relationships. Maintaining positive relationships is key when it comes to keeping site staff motivated and encouraged to get the work done. During the hiring process, employers need to decide what attributes are required and figure out how to not only test for aptitude, but also how to provide ongoing development of these skills.
Workforce Development in a Volatile Market
The work environment in the pharmaceutical and biotech industries these days is characterized by frequent upsizing and downsizing as a direct reflection of the ever-changing pace of product development. These conditions have led to a change in the landscape of the industry, from a primary dependence on the hiring of full-time employees to an “on-demand” approach to resourcing and the inclusion of consultants and contract workers.
When considering training and development, companies are on a “slippery slope” regarding consultants/contractors, as they are only to be provided training in order to successfully complete the job to which they are contracted, and not to grow outside that role (which could be perceived as development). Developing skills and broadening one’s knowledge base for future work is the responsibility of the individual in this case.A good CRA consultant/contractor will want to continue to grow in the role. By making an investment to keep skills up to par and adding self-training to their curricula vitae/resumes (e.g., taking courses to focus on “hot” therapeutic areas or novel study designs), such CRAs understand that this will increase their marketability for future contracts. By doing this, they also show a potential client that improving and adding to their skills is important to them.
Revisiting Competency Domains and Harmonized Core Competencies
Throughout ongoing training and development of the CRA, the strengthening of attributes and skills that are essential to the role should be the ultimate goal. Many of these align with the JTF competency domains and harmonized core competencies (see Table 1*).2,6 These competencies should yield a highly proficient CRA.
Creating a workforce development program addresses the challenge of inexperienced CRAs not being able to break into the industry, and maintains the skill set of existing professionals. Through continuous support of the CRA’s career path and ongoing development, organizations can demonstrate a vested interest in retaining the employee and, therefore, in reducing turnover. The ultimate result is an efficient and agile CRA workforce, and a clinical research industry that produces quality products for the healthcare market.
- Frestedt JL, Kablinger A, Smailes P. 2015. How to enter the clinical research field. Clin Res 29(6):52-7. [DOI 10.14524/CR-14-0058]
- Sonstein SA, Seltzer J, Li R, Silva H, Jones CT, Daemen E. 2014. Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Clin Res 238(3):17-23. [DOI: 10.14524/CR-14-00002R1.1]
- Olinsky B, Ayres S. 2013. Training for success: A policy to expand apprenticeships in the United States. Center for American Progress; 9-15.
- Collins M. 2015. Why America has a shortage of skilled workers. www.industryweek.com/skilled-workers
- Alan Chapman/Businessballs. 2016. Training and Learning Development. www.businessballs.com/traindev.htm
- Chittester B. 2015. 10 attributes of a great monitor. www.imarcresearch.com/blog/10-attributes-of-a-great-monitor
Nicole Tesar (firstname.lastname@example.org) is owner and director of clinical operations with Harmony Clinical Consulting Corporation in Avon, Ohio.
*To see all figures and/or tables published originally in this article, please visit the full-issue PDF of the December 2016 Clinical Researcher.