By Ed Miseta, Chief Editor, Clinical Leader
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A problem that seems to impact everyone involved in clinical research is the current shortage of CRAs. This problem is causing excessive turnover at CROs, climbing CRA wages, and frustration for sponsors who have to deal with changing staff members at their CRO. Pharma companies also have to deal with finding competent CRAs to hire.
A new partnership hopes it will be able to finally solve the problem. The partnership, called IN AWE, was formed via the collaboration of VIARES, SEC Recruitment, a clinical staffing firm, and IAOCR, the accrediting organization for the international clinical research industry.
IN AWE will offer a comprehensive early talent service that selects candidates and develops CRA competencies in them. It will also independently assess their ability to demonstrate knowledge and skills in the workplace. Those who are able to demonstrate those competencies will be placed in entry-level positions with employers in the industry.
Employers generally want to hire CRAs with at least two years of industry experience. That has been a problem for an industry that is rapidly growing and has seen the retirement of more experienced CRAs. New talent is simply not becoming available fast enough to meet the demand for new CRAs due to both industry growth and attrition.
Real Skills For Real Jobs
According to a press release issued by IN AWE, the CRA training will cover knowledge, skills, and behaviors that entail what it means to be a fully-competent CRA. The program is accompanied by an accreditation process which assesses a CRAs competence. The accreditation was put in place to assure future employers that candidates have the required skills to function as a CRA. The newly qualified CRAs will then be placed in positions that until now have gone unfilled.
All that being said, can this effort actually make a dent in a problem that has been brewing for years? Jacqueline Johnson North, CEO and co-founder of IAOCR, thinks it will. She notes the main reason for the CRA shortage has been the lack of development of new talent in the industry.
“Pharmaceutical companies are constantly demanding only CRAs with several years’ experience to work on their clinical trials,” says North. “This has also resulted in CROs being pressured into hiring only experienced people. The consequence has been a dwindling pool of CRAs because little new talent is being developed and more experienced CRAs are moving into roles such as project or line management. This is not a sustainable business model and has been a key contributing to factor to the current shortage. Rather than focusing on the competence of an individual to undertake a task, the model focused solely on years of experience.”
If the industry truly wants experience, some may question whether a new training program will be enough to solve the problem. North acknowledges that training alone is not the answer, and points to IN AWE’s solution which hones the skills of entry-level personnel to a competent standard that will support the needs of the industry and provide CRAs that can fill open job roles.
“The key to effective training is ensuring it is specifically developed for the CRA job role and that it is completed with a competency-based accreditation process,” states North. “This ensures that the individuals who undertake the program not only fully understand the theory, but can apply it in a real-work situation.”
There Is More We Can All Do
Universities can certainly help with the problem, and North believes it is the responsibility of the clinical research industry to work with universities to help address the shortage problem. But she takes it a step further, noting the industry as a whole needs to be promoting the career to both university and high school students. “It is our collective responsibility to ensure potential CRAs of the future are aware of the clinical research industry, what it involves, and what it can offer them as a career,” she says.
Despite what some companies and organizations are doing to solve the problem, there is certainly a lot more that pharma and CROs can do to help with the problem.
First, pharma companies and CROs should collectively re-evaluate their thinking around who they want working on their clinical trials. Do they want someone who has done the job the longest or do they want individuals who are the most competent? North correctly points out that experience does not necessarily equate to competence.
“As an industry we need to focus on developing people to be competent using objective performance standards rather than relying on a subjective parameter like experience,” she says. “This change in mind set will allow the whole industry to operate more effectively, by focusing people’s skills and capabilities in the right areas. We need to be looking at how we can bring drugs to market quicker and more cost effectively. That will mean working smartly, and for us a focus on competence is the smart choice.”
Finally, being in a CRA position is a tough job. The extensive travel that generally is required makes it all the more difficult. But, since the job is unique in many ways, it also provides a plethora of opportunities not seen in other careers. The variety of work as well as the travel can make it an appealing career choice for many.
“Competency is a key aspect of the job,” adds North. “When a person is competent in their job, they will work more effectively and efficiently. That competence will also help to build their self-confidence. An industry-wide focus on competence will not only address the CRA shortage. It has the potential to revolutionize how the entire industry operates.”