What You Need to Know to Become a Clinical Research Associate
A clinical research associate (CRA) is a health care or life sciences professional who oversees clinical trials on behalf of pharmaceutical companies, medical research institutes and government agencies.
What You Need to Know to Become a Clinical Research Associate (CRA)
CRAs are sometimes called clinical monitors or trial monitors. A key part of the job is to monitor Good Clinical Practice (GCP) guidelines such as the ones developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
CRAs tend to be classified by the Bureau of Labor Statistics (BLS) as clinical and medical informaticians.
As such, salaries range between $54,958 and $69,331 according to Salary.com, and the average salary for a CRA in 2022 was $62,432. Payscale.com cites a similar range, listing a median salary of $61,984 with a low of around $46,000 and a high of around $96,000.
Payscale also notes, “For a Clinical Research Associate, progressing to a Clinical Trial Manager role may result in a significant raise...Clinical Research Associates moving up in their careers tend to step into positions as Senior CRAs or Clinical Project Managers.”
Certification and Requirements
The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified Clinical Research Associate (CCRA). It is not a requirement to be CCRA certified to work as a CRA, but it does give one an advantage.
According to the ACRP, CRA certification eligibility includes documentation that one has worked independently of the investigative staff conducting research at a site or institution.
This means the employee does not report to the primary investigator or site manager and doesn’t have the ability to otherwise change or manipulate clinical trial data. These employees workk on behalf of the sponsor, which is generally a pharmaceutical or device company, a granting organization, a physician or a university department.
It also compiles a lengthy list of duties that the applicant must have performed for a cumulative 3,000 to 6,000 hours. The CCRA is designed for people already working as CRAs.
The role requires a bachelor’s degree or higher and 3,000 hours performing essential duties as an LPN, LVN or RN. One can also have an Associate’s Degree and a minimum of 4,500 hours performing essential duties, or work as a Medical Assistant, Lab Technician or have a High School Diploma and a minimum of 6,000 hours of performing essential duties.
To some, the CCRA certification seems like a Catch-22—in order to be certified, you need to already have the job, and to get the job, you need to be certified. However, there are ways to work with the system.
Short of a rather circular line of thinking—getting a job as a CRA to get experience as a CRA—there are educational courses. Numerous courses are online, but be careful—there are a lot of scams out there.
In that respect, it would be a good idea before taking a course to make sure it is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
Having a life science or medical degree is one the strongest educational backgrounds one can have for this position. Keeping in mind that ICH-GCP is the heart of being a CRA, any and all coursework on Good Clinical Practice as outlined by the ICH is also helpful.
It’s questionable if these are really shortcuts, or if shortcuts really exist, but here are a few ideas—or strategies—that might shorten the time to employment.
1. Working Up to the Role
Instead of attempting to jump right in, there are Clinical Research Coordinator (CRC) and Clinical Trial Assistant (CTA) jobs available that may be beneficial for those who are not ready to become a CRA right away.
2. Consider the Employers
Very broadly speaking, CRAs work for pharmaceutical companies or contract research organizations (CROs). A CRO handles much of the clinical trial work for biopharma companies, running the clinical trials and providing statistical analysis and resources.
Many people looking for CRA jobs may check the big companies first, ones like Johnson & Johnson or Pfizer. However, smaller biopharma companies, hospitals and even doctors’ offices may have a need for CRAs, and they will likely have less applicants for each role.
3. Take Relevant Coursework
Focus on coursework that falls under the GCP guidelines. This could be the best route for those who lack the necessary experience for an entry-level CRA position.
4. Don't Only Apply for Advertised Positions
Admittedly, this seems counterintuitive. And by and large, big companies are going to post jobs and use recruiters. Smaller companies, though, may be more open to “spontaneous” applications.
Sending a cover letter to some companies that aren’t actively recruiting CRAs and clearly stating one's intent could be a great, albeit unconventional, way to get a foot in the door.
All told, being a clinical research associate can be a fascinating, well-paying job with numerous opportunities. If you're ready to make the switch and become a CRA, know that you'll be making a positive difference not only for yourself but in the lives of the people and patients you serve.