Why Clinical Research Companies Cannot Hire CRA’s Without Experience?

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, there are three main reasons that actual experience is essential:

Theoretical knowledge of GCP and CRA functions does not ensure the ability of the candidate to work independently. More than half the time a CRA spends on clinical sites, he is the only representative of the sponsor company. Sometimes there are co-monitors, and then colleges can provide assistance to the fresh CRA, but usually clinical sites are in different geographic locations, and the CRA must work alone, which considerably lessens the opportunities to teach new employees, and increases mistakes and inadequate job performance.

Even if the CRO (Contract Research Organization) were to take the risk of hiring an inexperienced CRA, he or she would not be approved by the sponsor that actually hires the CRO to run the clinical trials. CRO’s usually don’t run their own trials, they just provide clinical research services to pharmaceutical and R&D companies who, for different reasons, have chosen not to run the trials themselves, and have outsourced the job to a CRO or SMO (Site Monitoring Organization). Most of the sponsors of public companies have a responsibility toward their investors, and approval of inexperienced CRA’s could cause serious trouble if anything were to go wrong.
Government Drug Approval Agencies and Ethics Committees usually check résumés of key personnel involved in clinical studies, so companies are obligated to hire experienced staff.

How This Catch-22 Situation Can Be Solved
Catch-22 is a term coined by Joseph Heller in his novel, Catch-22, describing a situation in which an individual has to accomplish two actions that are mutually dependent on the other action being completed first. A familiar example of this circumstance occurs in the context of job searching. In moving from school to a career, one may encounter a Catch-22 where one cannot get a job without work experience, but one cannot gain experience without a job. Catch-22 situations are also sometimes called chicken or egg problems.

Naturally, there are ways in which this “Catch-22” is somehow resolved; otherwise the industry wouldn’t exist. Most often, it happens through “hidden job market” hiring, when someone within a CRO, or sponsor, turns a blind eye on an applicant’s absence of direct monitoring experience. They might promote internally some clinical coordinators, or hire friends from the outside. Although such practices do not account for a significant portion of the job market, they can’t be ignored. Such hiring is becoming more and more risky, because of the danger of responsibility for inadequate hiring falling on a person who has made such a decision. Lately, there are more and more sponsors and CRO’s that feel such a serious lack of experienced CRA’s that they are creating co-monitoring positions and CRA trainee positions. However, the competition for these positions is fierce. Therefore, more and more companies use unpaid internships programs and in some cases, internships that the trainee must pay for. Although it sounds frustrating for people who have already spent from $60,000–$100,000 on university degrees to have to spend even more money for internships where they are actually working, this is not about evil employers. Employers usually cannot profit from the work of inexperienced trainees, and internees are often assigned tasks that are duplicated by experienced staff.

Because of high competition for internship positions, providers of internship programs usually require at least GCP certification. Because most of a CRA certification is possible only after the candidate has already had some CRA experience (ACRP certification, for example), referring candidates from the industry to certifying institutions can solve a Catch-22 situation that is created when a person cannot get certified because of lack of experience, but cannot get experience before becoming certified.

It is also useful for an aspiring CRA to cultivate personal relationships with industry professionals who can provide references. These might include recruiters, experienced CRA’s, and others.