Experience Requirement Causes a Catch 22 In Clinical Research

The clinical research industry is experiencing growing pains.  With more clinical trials gaining FDA approval in 2015 than any of the 60 preceding years, the industry is not showing any indication of slowing down.  But amidst this success a pervasive issue of shortages of qualified Clinical Research Associates (CRAs) is rearing its head.  The shortage of professional talent could put a damper on not only the growth of companies, but of greater concern is the effect on the speed and execution of studies being performed and ultimately the timely access to new medications and treatments for those who desperately need them.  A clinical trial cannot function without a clinical research associate monitoring the progress of the study.  The “Catch 22” that exists is that many potentially well-qualified individuals are not being hired as a CRA because they do not have enough clinical research experience, yet this wary industry is not providing the training or experience needed for the applicants to become qualified.  The result of this conundrum in a growing market is a shortage of qualified staff that is reaching an alarming number.  This issue is tripping up the industry and causing a ripple effect of consequences for study sponsors, contract research organizations, and patients.  Clearly more innovative training solutions are needed and Clinical Research Fastrack is working to bridge the gap in the industry.

Why is there a shortage of qualified clinical research associates?

CNN Money rated the CRA profession as one of the top 10 best jobs in America, so how is it that the industry is not flooded with talent?  As counterintuitive as it seems, the industry has unwittingly created barriers and challenges to prevent applicants from entering the industry. Training and experience are becoming elusive necessities.  The number of trials has grown and new developments in biotechnology and innovative research are leading drug discovery to new heights.  The rapid growth of the industry has left many gaps as Pharmaceutical Companies transitioned their processes to become more efficient. Unfortunately, in this shake-up, the training available has been neglected. Three key players contributed to the vacuum caused by the changes in the industry:

• Pharmaceutical Companies
• Contract Research Organizations
• Freelance CRAs

Pharmaceutical companies used to perform trials in-house and they offered specialized training to their staff to ensure successful studies.  The pharmaceutical companies, however, desired to focus on developing new drugs versus running trials.  They also wanted to avoid the inherent conflict of interest in conducting studies on their own drugs. So, over roughly the last decade, big pharma companies have largely outsourced clinical research responsibilities to contract research organizations (CROs).  Up to 80% of clinical research professionals work for contract research organizations rather than pharmaceutical companies[2]. For this reason, pharmaceutical companies are no longer offering post-graduate training for their CRAs because they keep fewer of them in-house.

Because of this shift from in-house to outsourced trials, the contract research organization performing the research is responsible for supplying the talent for the pharmaceutical sponsored studies, and these organizations do not commonly offer training for the qualified candidates. The CROs have been so busy running trials, they have not invested the time or resources for training.  Furthermore, with such high demand for qualified CRAs it is no longer financially beneficial for these research organizations to offer their employees specialized training.  Once a CRA is trained they quickly become a target to be recruited by competing CROs.  Once a CRA starts doing a good job in this industry, a wealth of opportunities open up for them.  The salaries and offers to experienced CRAs are well over $100,000 per year as these professionals are in high demand.

Adding to this issue is the freelance clinical research associate.  Highly qualified CRAs are finding it very lucrative and desirable to go off on their own.  Freelance CRAs are not obligated to any particular pharmaceutical company or CRO and as a free-agent of sorts, they can pick and choose studies to work on while negotiating their own pay.  As independent contractors, freelance clinical research associates can bill over $100 per hour.  The most successful freelance CRAs are making over $200,000 annually.

To combat this difficult situation, pharmaceutical companies are beginning to revive the practice of in-house clinical trials, but are finding it challenging to compete financially with the contract research organizations and the elevated pay of freelance clinical research associates.  This environment of competition allows qualified CRAs and other trial staff to continue to raise their rates.

Another concern to the industry is that projections hint that the highly qualified and experienced CRA workforce is nearing retirement[4] while the number of prospective clinical study graduates is not nearly large enough to fill the growing need.  Clearly the industry needs a new “pipeline” of clinical research professionals ready to take the baton in this exciting and growing field.

CRA Shortages Can Cause Delays in Drug Approvals and Increased Costs

The lack of qualified clinical research associates is having far-reaching effects.  The bottom line is that studies are becoming more expensive, staff is becoming more scarce and medication is not getting into the hands of the patients who need it.  And somewhere in all of this, quality may also become compromised as budgets require the hiring of less qualified personnel.

More expensive studies. Because clinical research associates are in such high demand, their financial compensation rates keep rising.  This raise in pay for CRAs affects the entire budget of the study, and companies are often forced to move studies to different countries to combat their strained budget.

Less qualified staff. Clinical trials have strict regulations, and compliance with budgets is very important.  Because the clinical research associate position is critical to the success of a trial, contract research organizations are forced to hire personnel and they often do not meet the experience qualifications.  This is the result of the organization’s need to accommodate staff pay while staying within budget.

Delays in medicine. With strained budgets and personnel shortages, clinical research trials are falling behind schedule.  Study costs are rising while timetables are extending.  The most worrisome result of this interruption in production is that new medicines are inaccessible to the patients who need them.

A Fastrack Solution to the CRA Shortage

Considering the extreme consequences of the CRA shortage, the industry needs to find a solution to rapidly train, qualify and “on board” more researchers.  Over the past decade the industry has become caught up in determining what makes a “qualified” clinical research associate. The commonly accepted qualifier for a CRA is that s/he has 2 to 4 years’ experience working as a clinical research associate.  But experience doesn’t necessarily translate into expertise.  And the current path to experience is stymied with many road blocks.

The ACRP (Association of Clinical Research Professionals) has identified that this time-served experience does not mean that the CRA has the necessary skill set for all individual studies.  This can affect study quality and timeline.  The focus needs to shift from a time-based qualifying to a skill-based qualifying.  The industry needs competence rather than chronology.

Jim Kremidas, the Executive Director of the ACRP, said,

“It’s a random marker. Time in a job is not necessarily indicative of whether somebody does it well or not.  We suggest throwing the two-year arbitrary experience requirement out the window and focus on the competencies required for the job.  We’d like to define an industry standard that everyone agrees upon, one that says if a person has this type of education, training and experiences, they are qualified to be a good CRA.”

As recommended by the ACRP, eliminating a haphazard time requirement would be a great start to amending the clinical research associate shortage.  While experience is important, CRA’s need high quality experience and training to meet qualifications.  In an industry that is so vital to medical progression and human health, competence must be gauged by looking at aptitude, skills and experience.

New Training Programs Must Fill the Void

The most viable remedy for the clinical research associate shortage are specialized training programs geared exclusively toward training clinical research professionals. A few Master’s level programs do a good job training their students, and include internship experience, but these two-year programs are meeting the needs of the industry.   Only Clinical Research Fastrack offers a condensed, intensive 4-week training program, complete with classroom instruction, online learning and hands-on training at a busy clinical trial site.  Our graduates are endowed with expertise and experience.  Clinical Research Fastrack’s programs offer an accelerated path for researchers to gain training and experience.  At a time where we are experience serious shortages in the industry and the need for trained individuals has never been greater, Clinical Research Fastrack is filling a serious void.

As the industry shifts from experience to competency, the safest bet is to have both. Clinical Research Fastrack is offering the industry unparalleled preparedness with its innovative hybrid curriculum.  Adding specialized learning and on-site experience to our unique screening and networking capabilities produces graduates who are a cut above the competition.

In such a fast-growing industry, both job security and earning potential are at all-time highs.  For students who want to take advantage of this opportunity quickly, now is the time to apply for a boot camp training program. Newcomers to research are halted by the gatekeepers looking for experience.  The and arbitrary time and experience requirements has crippled the industry.  Before the field transitions away from arbitrary time and experience requirements, training with Clinical Research Fastrack enables you to enter the field and start on a successful track towards a CRA position. While the industry is pushing forward toward new standards in the coming years, an opportunity to jump into the field of clinical research exists.  Success is at your fingertips with Clinical Research Fastrack.