How Are Clinical Research Associates (CRAs) Trained?

[updated 17 May 2024]

An essential first step in creating and assessing novel medicinal products is clinical research. A career in clinical research can provide numerous fulfilling, fascinating, and varied possibilities and career options for individuals with qualifications or expertise in the life sciences. Pharma, biotech, medical device, and CRO organizations worldwide are in constant need of clinical research associates due to the growing demand for novel preventive and treatment approaches. If you want to learn how to become a clinical research associate and launch a career in Clinical research, take into account the following:

A CLINICAL RESEARCH ASSOCIATE: WHAT IS IT?

An individual that oversees the conduct of clinical trials is known as a clinical research associate (CRA). Depending on the role or the company, a CRA may be involved in part or all of the clinical trial process.

WHAT ARE A CLINICAL RESEARCH ASSOCIATE'S RESPONSIBILITIES?
A CRA's primary duties usually consist of keeping an eye on clinical activities and study locations, organizing research methods, updating study documentation, and managing clinical data systems.

If you work as a field-based clinical researcher, the majority of your time will be spent traveling to various sites and interacting with medical professionals in hospitals, clinics, and trial sites. Depending on the firm, you might work from home or in an office for the remaining portion of your day. Certain organizations may employ internal CRA personnel whose primary responsibilities are document review and management, with infrequent site inspections.

ARE CLINICAL RESEARCH ASSOCIATES IN DEMAND?
The demand for novel therapies has skyrocketed in recent years due to factors such an aging population, an increase in healthcare facilities, rising healthcare costs, and advances in technology and research. As a result, more businesses are already hiring for new positions in clinical research, and this trend is probably going to continue in the years to come.

WHAT SKILLS OR EXPERIENCE DO I NEED TO GET HIRED AS A CLINICAL RESEARCH ASSOCIATE?
To work in clinical research, one often needs a degree in a life science or a related field. If you lack the necessary credentials, there are still training programs and courses that can help you get started.

Qualifications: A Master's degree (MSc. or equivalent) or a PhD can be helpful and could give you invaluable expertise in clinical research, however they are not normally required. Having a pertinent PhD can also be helpful because certain employers will consider it relevant job experience that can help you advance to more senior roles.

Certifications: To become a Certified CRA, one must pass the certification exam offered by the Association of Clinical Research Professionals (ACRP). While not mandatory for the majority of CRA positions, holding a CCRA certification offers significant benefits. Everything a CRA has to know is covered in the exam, including data management, product development, regulation, scientific principles, and research design.

Training: A comprehensive understanding of the requirements to become a CRA can be obtained through a variety of available courses. Make sure any training program you join up for is approved by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP) before committing to anything.

WHAT EXPERIENCE IS NECESSARY FOR A JOB AS A CLINICAL RESEARCH ASSOCIATE?
It can be difficult to land your first clinical research position, and many recent grads can get irritated by the "catch-22" situation where they are unable to find work due to a lack of experience, but are also unable to obtain experience due to their inability to find work.

If you don't have any relevant work experience, your chances of landing a position as a clinical trials assistant (CTA) are higher. Working as a CTA will help you gain the necessary expertise to transition into a clinical research assistant position while supporting all trial activities.

In general, larger businesses are more likely to provide programs like graduate assessment days and internships since they are better suited to hire recent graduates with less experience. Look for openings on the career websites of the largest pharmaceutical corporations, medical device manufacturers, and contract research organizations by conducting research on them. Keep a watch on their social media platforms as well, as they are excellent resources for learning about graduate programs.

One way to obtain experience could be through working on projects for school or in a healthcare organization. While these are excellent means of gaining experience, you may need to accept a more junior role that pays less than you are used to in order to adjust to the differences of working in a commercial setting later on.

SUGGESTIONS FOR APPLYING TO JOBS IN CLINICAL RESEARCH
Finding the ideal clinical research employment might be difficult, even if you have all the necessary training, education, and work experience to become a clinical research associate. Your CV will have a higher probability of success if you make a few easy tweaks to your approach.

Maintain a realistic outlook
Regarding the kinds of employment you can get, be realistic. You won't likely be recruited for anything more than an entry-level position if you don't have any prior industry expertise. Applying for senior CRA positions or clinical project manager positions should only be done if you are a seasoned professional with the necessary experience. Instead of wasting time and energy creating numerous speculative applications, adopt a more focused strategy.

Emphasize the applicable experience you have
When applying for a position as a clinical research associate, make sure you carefully read each job description and highlight on your resume any relevant experience that fits the job requirements. In your cover letter, you should tailor it to the particular organization and explain why you are interested in working there as well as how your qualifications align with the job's needs. Employers and recruiting consultants in the life sciences are searching for applications that are the most pertinent, and they will quickly disregard those who have not taken the time to personalize it.

WHICH DIFFERENT CAREER PATHS ARE AVAILABLE TO YOU?
There are many avenues for professional advancement in clinical research, including chances provided by CROs, pharma, biotech, and medical device businesses. Although roles will differ from firm to company, clinical research associates (CRAs) usually advance to become senior CRAs. It is possible for CRAs to advance to the position of clinical director or even vice president with the correct expertise.

There are usually three primary paths one might take in the clinical research field once they have attained senior level as a CRA. One of the following roles will be yours: project manager, personnel manager, or manager of the trial process.

Clinical trial management: Typically in charge of organizing, supervising, and managing the trial's several facets. Staff supervision, study instrument and record implementation, trial budget oversight, and strategy trial input are typical responsibilities.

Clinical team management: In charge of overseeing associates directly as their line manager. Clinical team managers will oversee and assist team members, make sure personnel receive proper training, assess the efficiency of business procedures, and organize opportunities for professional growth.

Clinical project management: It is tasked with organizing and supervising clinical studies as well as assessing clinical data. Daily responsibilities include keeping track of studies, making sure projects are completed on schedule and under budget, analyzing study data, and creating trial schedules.