What makes a good 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).

Salary Range

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 is $62,432.

The Chron writes about CRAs: “The minimum educational requirement for this job is a bachelor’s degree in chemistry, biology or one of the life sciences. Some employers may prefer hiring entry-level clinical research associates who have one to three years of experience in clinical research but learn their job functions by training with experienced medical scientists. Other essential qualifications are observation, communication, critical thinking, decision-making, data analysis and computer skills.”

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 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 is an advantage. 

The ACRP notes CRA Certification eligibility includes documentation that you have worked independently of the investigative staff conducting research at a site or institution, which basically means you don’t report to the primary investigator or site manager and don’t have the ability to otherwise change or manipulate clinical trial data; that you do work 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. So clearly, the CCRA is designed for people already working as CRAs. 

The educational requirements are a bachelor’s degree or higher and 3,000 hours performing essential duties as an LPN, LVN, RN. You 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.

The question becomes, how does one get a CRA job? Are there shortcuts? Because 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.

Education

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 you 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 pretty much a requirement.

Shortcuts

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. Prior Experience

This isn't really a shortcut at all. But there are Clinical Research Coordinator (CRC) and Clinical Trial Assistant (CTA) jobs.

CRA Career & Jobs notes, “It may also be a good idea to volunteer for any duties related to clinical trials, but it’s far from enough.” Like all volunteering, make sure it’s a valuable experience and that you aren’t being taken advantage of.

2. Consider the Employers

Very broadly speaking, clinical research associate works for pharmaceutical companies or contract research organizations (CROs). A CRO specifically handles a lot of the clinical trial work for biopharma companies, running the clinical trials and providing statistical analysis, resources, etc. 

They note that most people looking for CRA jobs hit 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. 

In fact, CRA Career & Jobs states, “If you start searching online, you will eventually find many small to mid-sized CROs. Most people never apply for these companies, which is a shame, because it’s actually easier to get employed by these.”

3. Take Relevant Coursework

Focus on coursework primarily in GCP. CRA Career & Jobs says, “If you don’t have any monitoring experience, you will increase your chances to get an entry-level CRA position if you take certain courses. If you have spent a couple of weeks, or preferably months, learning GCP you will meet the basic requirements to begin training as a CRA.”

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. 

To that extent, CRA Career & Jobs gives two pieces of advice: send your CV and cover letter to some companies that aren’t actively recruiting CRAs, and clearly state why you’re interested in the company “and you would be very happy if they contacted you should any open positions occur.”

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. 

Although there are no exact rules, general educational requirements for a CRA role is typically a bachelor of science (BS) or a bachelor of art (BA) degree in life sciences, medical sciences, or healthcare related field such as nursing. Advanced degree is not required, but can be helpful for career progression.

Skills

CRAs perform variety of functions relating to clinical trial. As different functions require different skill sets, below are some skills that can be helpful in a CRA’s job performance:

1. Excellent communication skills (both written and oral). This is important as CRAs work with clinical trial sites (Principal Investigator and staff), regulatory review boards, key opinion leaders (KOLs), and colleagues.
2. Ability to motivate and train others. This goes along with the communication skills. CRAs will need to train and monitor the progress of clinical trial conduct at different clinical sites.
3. Attention to details. CRAs will need to be able to see mistakes and identify incorrect trial data / results. The work also involves documentation and recording of information. Detail oriented skills is critical to the monitoring work to ensure that clinical trial results are recorded appropriately and are accurate based on source data on medical records.
4. Problem solving skills. Unexpected events and issues often will come up throughout different phases of clinical trial. CRAs are the main contact for all the issues that may come up. Thus, CRAs should maintain flexibility and positive approach toward unexpected issues.
5. Multi-tasking, time management, and organizational skills. Multi-tasking skills are essential as CRAs are often handle different tasks at the same time. Time management skills are the key to effective work schedule arrangement in order to avoid overload. Organizational skills will help CRAs when working with stringent record keeping and regulatory requirements from regulatory bodies that regulate clinical trials.
6. Ability to travel. Although travel can vary depending on the type of position, CRAs are expected to travel to clinical sites as needed. Ability to handle travel both domestically and internationally is one of the skills needed for CRAs.
7. Knowledge of good clinical practice (GCP) and FDA Code of Federal Regulations (21 CFR 11, 50, 56, 312, 812, 45 CFR 46). These are some of the documents that govern clinical trial conduct. Familiarity with these documents is essential. If you are new to the industry, they can be learned.

Photo credit: Neckarsulm Education Center, by Detlef Schobert, flickr

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