If you haven’t heard the story of TAK Flight 363, pay attention — it might save you hundreds of thousands of dollars or more on your next clinical research study by protecting you against CRA fraud.

But how is an airline flight relevant to clinical research or CRA fraud, you ask?

As it turns out, in more ways than you might think.

You see, Flight 363 was a passenger airliner that found itself attempting to land at Kazan International Airport in Russia, on November 17, 2013.

Sadly, the jetliner crashed, and all passengers and crew on board lost their lives.

The investigation into the crash revealed that the captain of the flight had obtained his pilot's license using falsified documents. He had not completed the required training and had significantly overstated his flying experience.

The tragic story of Flight 363 underscores the grave consequences that can result when an organization fails to properly vet the qualifications and integrity of its employees.

While the pilot's fraudulent actions are reprehensible, the airline's hiring process allowed an unqualified pilot with critical skill gaps to slip through the cracks.

With devastating results.

As a clinical research employer or hiring manager, this cautionary tale serves as a reminder to closely examine your own hiring practices and ensure that you have the necessary safeguards in place to prevent unqualified people from joining your clinical research team.

This CCRPS guide helps you identify any vulnerabilities in your hiring process that bad actors could exploit, and gives you the tools and techniques to combat them. Let’s dive in.

Is CRA Fraud Really a Problem You Need to Worry About?

You might be surprised to hear this, but many senior-level professionals in the clinical research industry are somewhat indifferent to the issue of CRA fraud.

The sentiment seems to be: the system still works. If it ain’t broke, don’t fix it, right?

This isn’t an accurate assessment of the risks. The outcomes of bad hires in clinical research may not garner as much media attention as the crash of an airliner, but the stakes can be just as high.

A botched study might lead to an ineffective treatment wrongly progressing to the next stage of development, or an effective one getting delayed or canceled due to sloppy procedures. In both cases, the consequences can sometimes be literally life or death for the people whose lives the treatment affects.

Aside from the potential human costs, the direct monetary costs to your organization are also very real.

Recent data show that even small-scale RCTs can cost more than $200K on the lower range. And depending on who you ask, larger studies for medical device or drug development can cost anywhere from $49 million, or $54 million, to even $375 million per drug or device.

Incidentally, that much money can buy you about 18 airliners of the kind that were involved in the Flight 363 crash. In other words, the fallout of a ruined study can be monetarily even more damaging than writing off a state-of-the-art commercial jet.

The Real Costs of Fake Qualifications

The scenarios above aren’t purely hypothetical. In recent years, there have been many examples of Contract Research Organizations (CROs) and sponsor companies facing the consequences of inadequate CRA hiring and oversight.

In 2016, the FDA issued a warning letter to Semler Research, citing data integrity issues that stemmed from unqualified or inadequately trained clinical research staff, including CRAs. The resulting unreliable study results not only damaged the CRO’s reputation but also impacted the sponsors who had relied on their services.

Similarly, Cetero Research faced significant fallout from data integrity issues arising from poor CRA training and oversight, among other things. In this case, it led to the company’s bankruptcy and forced several sponsors to repeat studies at a cost of millions of dollars.

As these examples illustrate, the costs of hiring unqualified or fraudulent CRAs can be staggering, both in terms of direct financial losses and long-term reputational damage.

Cases of clinical research staffers lacking sufficient or authentic training and experience are also not isolated incidents. Authors of a 2021 study found that more than 12 percent of resumes for positions in health research were fraudulent.

Based on our interactions with dozens of the top employers in the industry, we believe that that number has grown. In 2024, we estimate that the incidence of applications with fraudulent qualifications can be as high as one in every five or six resumes in certain recruitment pools.

Fraud-proofing Your Clinical Hiring Process

As an employer, your responsibility includes ensuring that your hiring process is rigorous enough to identify and weed out candidates who lack the necessary qualifications, experience, or integrity to perform critical roles, whether those are CRAs, research coordinators, or data managers.

But as HR teams everywhere will attest, the prevalence and sophistication of fraud in the hiring process is constantly on the rise.

No sooner do recruiters spot and plug a racket than new ones turn up in a matter of days.

Effective screening means going beyond basic resume reviews and gimmicky portals that claim to solve the problem using simplistic tests and tools.

Here’s how.

1. Go Beyond the Obvious Clinical Role / CRA Red Flags

You already know the usual suspects:  discrepancies in documentation and employment history, vague answers to technical questions, and a lack of any verifiable digital footprint.

Push beyond these to uncover other telltale signs of an unqualified or under-qualified candidates, including:

Misunderstanding of Niche Skills

Candidates presenting a generic understanding of CRA or CRO functions, but lacking specific knowledge in the therapeutic area they claim expertise in. For example, claiming to be an oncology CRA but unable to explain common trial endpoints and standard-of-care treatments.

For instance, we came across a CRO manager who mentioned a CRA who kept referencing a “one five seven two form,” instead of the industry-standard “fifteen seventy-two” terminology. By itself, a single cue like this means nothing, but a lot of these subtle signs can add up — don’t ignore them.

Over-emphasis on Speed

Candidates may focus heavily on metrics of speed over quality. For example, boasting about high patient recruitment numbers without being able to discuss retention or data quality strategies. This may suggest a willingness to take shortcuts for the sake of appearances.

Cookie-Cutter Answers

Providing overly polished and rehearsed answers in interviews, particularly for scenario-based questions. This may indicate memorization rather than genuine problem-solving skills or an ability to adapt to unique trial complexities.

New AI tools can help you rapidly generate expert-level questions and answers, so that you don’t have to confine yourself to a limited bank of overused interview questions.

2. Use Multi-modal Interviews

Combine traditional in-person or video interviews with asynchronous video assessments, where candidates record their responses to a set of predetermined questions.

This allows you to evaluate a candidate's communication skills, poise, and subject matter expertise in a more controlled setting, while also making it harder for them to receive off-camera assistance.

Platforms like Glider.ai offer features such as facial recognition, eye-tracking to detect shifts in gaze, and audio analysis to flag suspicious noises like typing, whispering, and background voices.

Services like HireRight.com and Ferretly.com can bolster your background verification effort, with features such as AI-powered social media analytics to mitigate the risks of fraud and bad hires.

3. Maintain a List of Suspicious Employers and Institutions

There are actually unscrupulous businesses out there that offer fake employment credentials and even references for a fee. Maintaining a database of companies that consistently turned up on the resumes of disqualified candidates or bad hires will help you improve your process over time.

The same is also true of training institutions. There are dozens of sketchy institutions whose training is of questionable quality and sometimes even entirely nonexistent. (We’ve even come across accounts of self-professed training institutions whose curriculum consists of nothing but PDFs downloaded from the FDA website.) 

These businesses typically attract freshers with the promise of “guaranteed” jobs (a big red-flag for any training institution). Below are just a handful of examples.

4. Foster a Culture of Openness and Responsibility

While it may seem counterintuitive, creating a culture of fear can actually increase the risk of fraud going undetected.

When individuals feel that they will be severely punished, they go to greater lengths to conceal their deception, using more sophisticated methods and enlisting the help of others to cover their tracks.

Instead, consider fostering a culture of openness and responsibility, where CRAs and other staffers feel safe to admit mistakes, ask for help, and report concerns without fear of retribution.

There are five key elements to achieving this:

i. Establish Clear Reporting Channels

Provide multiple, confidential avenues for CRAs to report any concerns or suspicions of fraudulent activity, such as an anonymous hotline or a designated ombudsman. Make sure these channels are well-publicized and easily accessible.

ii. Encourage Open Communication

Create regular opportunities for CRAs to provide feedback and raise concerns, such as town hall meetings, surveys, or one-on-one check-ins with managers. Actively listen to their input and take appropriate action to address any issues they raise.

iii. Provide Support and Resources

Offer training, mentoring, and other resources to help CRAs succeed in their roles and overcome any challenges they may face. Make it clear that the organization is invested in their success and is willing to provide the support they need to do their jobs with integrity.

iv. Recognize and Reward Ethical Behavior

Publicly acknowledge and celebrate CRAs who demonstrate integrity, honesty, and commitment to quality. Use these individuals as role models and ambassadors for your organization's values.

Remember to address concerns promptly and fairly. When team members report issues or admit mistakes, investigate them promptly and thoroughly, and take appropriate action to address any shortcomings. Be transparent about the process and the outcomes to avoid any perception of retaliation or unfairness.

v. Foster a Sense of Shared Responsibility

Emphasize that maintaining the integrity and reputation of the organization is everyone's responsibility, not just management's. Encourage CRAs to see themselves as partners in the fight against fraud, and to take proactive steps to identify and prevent it.

5. Build Your Own “Talent Pipeline”

While hiring experienced CRAs is ideal, the reality is that the talent market is tight.

Investing in high-quality, targeted training for entry-level recruits can be a strategic solution to combat CRA shortages, accelerate a new hire's proficiency on the job, and improve your organizational outcomes. Here’s how:

Tailored Training

Partnering with established training providers like CCRPS, who specialize in CRA training, allows CROs to quickly onboard new hires with the core theoretical knowledge and practical skills needed.

We’ve worked with dozens of companies in the industry, and our clients consistently report significant performance improvements with new hires who complete our training program.

Address Specific Needs

Even with pre-hire experience, CRAs may have gaps in specific therapeutic areas or familiarity with your CRO's standard operating procedures (SOPs). Customized training can bridge these gaps, leading to faster deployment and better study outcomes.

Improve Cost-Effectiveness

It doesn’t take a mathematician to work out that the costs of training are insignificant compared to the cost of redoing studies or the cost of waiting endlessly to find the scarce "perfect" experienced candidate.

Trained entry-level CRAs reduce internal training burdens, improve project efficiency, and contribute to higher retention rates by fostering growth.

And of course, developing a reputation for investing in entry-level CRAs helps attract top talent in terms of candidates committed to career growth. This positions your organization for success even in a tight labor market.

The Disruptive Future of CRA Fraud Prevention

The current approach to CRA fraud (or fraud in any clinical role, for that matter) is largely reactive, patching vulnerabilities as they surface.

This status quo of reacting to ever-evolving fraud tactics is insufficient. To stay ahead of the curve, CROs and clinical research employers must become disrupters themselves.

I know the article title promised five actionable strategies, but in the typical CCRPS spirit of more is more, here are further ideas for you to consider — if your organization is ready for more advanced measures:

Leveraging Game Theory: Model the decision-making process of fraudsters to understand their vulnerabilities. Can strategic changes in hiring and verification make it less profitable or riskier for them to target CROs?

Data-Driven Prediction: Could tools built on large datasets identify early warning signs of high-risk candidates? Imagine a solution that analyzes transcripts, interviews, reference check patterns, and online footprints to go beyond just existing techniques.

Unconventional Techniques: What if your organization used ideas from outside the clinical research industry? For instance, using “red teaming” methods from cybersecurity can harden your process against fraud, and collaborating with academic researchers specializing in behavioral psychology could yield insights that discourage bad apples.

This isn't a call to embrace these disruptive ideas blindly, but rather a challenge to foster a culture of innovation and calculated risk-taking. CROs who lead the way in transforming the fight against fraud won't just protect themselves, they'll shape the future of a more secure and trustworthy clinical research industry.