Almost 20% of people seeking clinical research associate (CRA) jobs are submitting resumes that are either partially or fully fraudulent.

That’s according to craresources, a large recruitment agency that focuses on hiring in the clinical research space. Angela Roberts, head of CRA recruitment at craresources, said a recent search of the 40,000 CRA resumes in its database showed that 7,000, or 17%, contained falsified information.

But instead of fudging small bits of information—for instance, a CRA saying she worked for a company longer than she did—many of these resumes, said Roberts, are coming from people with no background in the field at all. And they are creative with their fraud.

“What’s frightening is this appears to be organized,” said Roberts. “Looking at these resumes, you can see where people are working together to falsify this information.”

Some candidates, she said, are industry savvy enough to claim that they worked for CROs that have since been bought, and thus getting proof of their employment would be difficult. Others say they have worked for CROs that never existed and they offer websites that look like a site a CRO would have, but are actually fake. Many list colleges and universities that don’t actually exist.

Roberts said she receives carbon copies of the same fraudulent resumes. Many list “MedPhase” as a CRO they worked for. MedPhase isn’t and has never been a CRO—but it sounds like one. Many will say they went to “Bible University,” “Cal Southern University” or “Cambridge Graduate University,” none of which offer research training.

craresources has learned how to spot these resumes, but the scary thing, said Roberts, is many who hire CRAs have not. Other recruiting companies that don’t focus on clinical research specifically and which compensate recruiters on the number of people hired may be missing the rampant falsifications. CROs, in a hurry to get much-needed CRA positions filled, may miss the fraudulent candidates as well.

The downside of this? Potentially huge, said Stephen Sonstein, director of Eastern Michigan University’s Clinical Research Administration Program.

“Someone who doesn’t have appropriate experience but who’s out monitoring study sites could compromise the ethical components of the study, as well as its data and its safety,” Sonstein said. “Studies are very expensive. All the time and effort put into the development of a protocol, the recruitment and the testing of a drug or device could be compromised, with the sponsor losing a lot of money.”

Roberts added that if the CRO is not closely monitoring the job the CRA is doing, bad CRAs may not be noticed for months.

“Many CROs and sponsors will go out to the sites with monitors and do assessments of their work,” she said. “If the CRO or the sponsor is not doing that, by the time they realize what’s happening, you’re three to six months in.”

Terri Hinkley, Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP), said the position of CRA is currently ripe for such fraud.

“It’s a profession with a lot of openings right now, and many find it quite attractive in that it pays well and there’s a lot of travel,” she said. “But nowadays, it’s very difficult to get started as a CRA, a corner the industry has backed itself into.”

Hinkely explained that, when the industry began to move to the outsourcing model, CROs took over on hiring CRAs. Many CROs hurried the hiring process, and sponsors were not happy with the CRAs the CROs hired. Sponsors then came up with the rule that CRAs needed to have a minimum of two years of experience before they could work on any studies for the sponsor. But there are few training programs for CRAs, and the ones that exist are very hard to get in to.

“There is, then, no clear path for a person to begin a career as a CRA,” said Hinkley.

ACRP and partners are hoping to change that. This spring, ACRP, as part of a pan-industry collaborative, published a list of competencies a CRA should have throughout the life cycle of their career. Hinkley said the list is meant to help shelve the strict criteria that a CRA must have two years’ experience, and to instead help employers turn to other criteria for considering whether a person would be advantageous to have on board as a CRA.

Hinkley said response has been big, and many CROs have agreed to begin imbedding these concepts into their CRA hiring processes rather than strictly following the two-year rule that gatekeeps many promising candidates out of the space.

In the meantime, how does the industry insure it is not hiring fake CRAs.

Laurie Halloran, president and CEO of the Halloran Consulting Group, and a former CRA who later developed CRA training for a large CRO, recommended against hurrying the hiring process. Always carefully check the person’s references, and go beyond that to check social media, too.

“Look on LinkedIn. Are they on there? Are they linked to any people you know?” said Halloran. “If they aren’t on there, aren’t linked to anyone you know professionally or don’t have any contacts you recognize, that’s a big red flag. This is a small industry and everyone seems to know everyone else.”

In addition, be a better interviewer. Make sure to pose specific questions about the details of monitoring a trial, she said.

“I would ask the person for the step-by-step process they would follow when they get to a clinical research site, remembering to push back if they get vague, and say, ‘No, I need more detail on that—what specifically would you do?’” said Halloran.

Be careful, adds Roberts, of conducting job interviews on the phone or via Skype, as candidates with no background in CRA work may have someone else who knows the field do the interview for them. Roberts has candidates show her their driver’s license and hold it up to their face to confirm identity.

Thus far, few CROs want to admit that this has happened to them. No lawsuits have been filed against fake CRAs, though those who watch the space feel this is coming soon.

This article was reprinted from Volume 21, Issue 20, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »