A Day in the Life of a Clinical Research Associate

Every pill, cream, tonic, and capsule that a pharmacist passes over the counter to an individual has taken a long journey from concept to the point of sale. In fact, many medications that do not require a prescription, such as those found in the allergy, cold, and flu aisle, also go through the same arduous process.

Before a drug can be prescribed and sold, it has to be proven both safe and effective. To obtain this proof, pharmaceutical companies, universities, and health organizations put drugs through the clinical trial or clinical study process. In the clinical trials world, the company that provides financial support to a research group selected to put the drug through clinical trials is known as a contract research organization or CRO. Primarily, CRO organizations provide financial support pharmaceutical development as well as biotechnology for agricultural and medical device industries.

In the case of pharmaceuticals, during a clinical trial, drugs that have not yet been approved for sale are administered to vetted participants in a controlled manner. Clinical trials involve a great deal of documentation, analysis, observation, and organization. A team of professionals is involved in the administration of a clinical trial, including a clinical research associate (CRA).

The CRA acts as a liaison between the study’s sponsor CRO (e.g., pharmaceutical company) and the clinics where the study takes place. Because results of a clinical trial must be kept entirely transparent and not influenced by the interests of the sponsor, this is a critical role. A successful CRA will be detail oriented, highly educated, and able to communicate clearly with both sponsor and clinical representatives.

A clinical research associate works both at clinical sites and sponsor locations. During a trial, the CRA conducts regular site visits—virtually and physically—to ensure proper progress and record keeping on the part of the clinical site.

CRAs are often responsible for multiple trials at one time, which can mean significant amounts of travel between these sites. In some cases, a CRA may be assigned to a specific geographical region, which can limit travel.

Typically, a clinical research associate does not have direct contact with the participants involved with the study. However, CRAs must be able to work in a collaborative environment, coming into frequent contact with the clinical team at the study site and the supervisors from the study sponsor. Clinical research associates work in the middle of the chain of command which begins at the top with:

• Contract research organization (CRO) or sponsor
• Principal investigator (PI)
• Clinical research associate (CRA)
• Clinical research coordinators (CRC)

In short, a CRA is focused more on data, accuracy, and quality control while a CRC collects data and interacts with patients. Dan Sfera, in his YouTube channel titled The Clinical Trials Guru, summarizes the CRA profession with this description: “CROs select various PIs across the country, and PIs make sure that sites are following good clinical practices and protocols. They ensure this by hiring CRAs who look at all the recorded data and do not interact with patients when they are completing a site visit.”

The daily responsibilities of a CRA are largely dependent on the stage of the trial they are supervising. As such, below is a breakdown of the typical responsibilities of a CRA during the beginning, middle, and end of a clinical study.

Every clinical study must take place in a clinical location that is properly equipped. The CRA plays a critical role in selecting a site for a clinical study and may even be asked to suggest sites based on his or her previous experiences. CRAs may also evaluate the applications of sites that self-select as eligible for a particular study. A pool of potential study sites is narrowed down by having sites complete and submit a feasibility survey.

When the pool of sites has been narrowed down, the clinical research associate conducts site selection visits with the chosen locations. During these visits, the CRA spends up to half a day confirming the validity of the feasibility study, meeting with the team (particularly the assigned coordinator), and observing the capabilities and equipment at the facility.

Upon completion of the site visit, the CRA compiles a report for the study sponsor and presents his or her findings and recommendations for proceeding with the study.

Once a site has been selected, the CRA is now responsible for ensuring that the site knows the sponsor’s required protocol and is properly set up to conduct the study. Throughout the study, the clinical research associate conducts site visits at regular intervals to ensure that protocols are followed, and data is effectively collected.

Depending on the study, CRAs may conduct in-person site visits as well as virtual visits. In recent years, the use of remote visit technology has allowed CRAs to review paperwork online, for instance, and reserve in-person visits for necessary personal interactions. During site visits, the CRA ensures that the study is proceeding with good clinical practices at all times. More details on the specific practices are available below.

Ultimately, since the CRA is a liaison, developing and maintaining positive relationships is an essential part of the job. During the trial, the CRA must communicate effectively and help the clinical staff in any way that is appropriate to ensure the study progresses smoothly.

At the conclusion of a study or when it becomes necessary to end a study—e.g., when the study’s enrollment is too low—the CRA typically conducts a closeout visit.

During the closeout visit, the CRA verifies that all paperwork is in order and that all obligations have been met on both sides. The verification process may mean ensuring the trial drugs are returned or destroyed, completing and properly filing all documentation, and compiling all information necessary to complete a final report for the study sponsor.

Based on the responsibilities outlined above, it should come as no surprise that CRAs must have a knack for detail. Proper documentation, filing, and storage are all critical parts of the job description. It is up to the CRA to ensure that both the sponsor and clinic understand their obligations at every point of the study and that all policies and procedures are being followed to ensure successful data collection.

In addition to being detail-oriented, a good CRA also pays heed to the ethics of the position. Clinical trials and studies can have extensive consequences for the organizations that sponsor them, as well as for the trial participants, and eventually, for consumers at large. CRAs act as an important monitor for ethical issues and should be able to stand up to any perceived transgressions.

Above all, it is essential that a CRA understand and be able to implement good clinical practices (GCP) successfully. The GCP guidelines are an internationally developed set of standards from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that details the specifics of how to ethically and effectively conduct drug trials with human subjects.

The ICH topics are divided into four categories: quality, efficacy, safety, and multidisciplinary. The guidelines can be found in more detail on the ICH website. Upholding the GCP standards is the most important part of the CRA job, meaning that any CRA must not only be familiar with GCP but also able to recognize and enforce these practices in a clinical setting.

While certification is not a legal requirement to work as a clinical research associate, as with many professions, it can provide an important differentiator when looking for employment or career advancement.

Two main bodies offer certification for CRAs: the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).

To earn the Certified Clinical Research Associate (CCRA) credential from ACRP applicants must either:

• Have a bachelor’s degree with at least 3,000 hours of experience in the CRA role
• Be a licensed practical nurse (LPN), licensed vocational nurse (LVN), or registered nurse (RN), or hold an associate’s degree with at least 4,500 hours of experience
• Have a high school diploma with at least 6,000 hours of experience

Applicants also have to submit proof of their current job description and resume and pass the CCRA exam. To maintain certification, CCRAs must complete at least 24 hours of continuing education credits and be recertified every two years. Beyond the CCRA certification, ACRP also offers certifications for project managers, research coordinators, and principal investigators, as well as an umbrella certification for clinical professionals.

To earn the Certified Clinical Research Professional (CCRP) certification from SOCRA, applicants must either:

• Have at least two years of full-time experience as clinical research professionals
• Have a degree in clinical research plus at least one year of full-time experience
• Have a certificate in clinical research (undergraduate or graduate), a degree in science, health science, pharmacy or a related field (associate’s or bachelor’s), plus at least one year of full-time experience

Applicants must also pass the CCRP exam and be recertified every three years. Recertification requires 45 total hours of continuing education credits.

The critical difference between the SOCRA and ACRP certifications is that ACRP specifically certifies CRAs while the SOCRA certification can apply to other types of clinical research professionals.

Matt Zbrog

Writer

Matt Zbrog is a writer and freelancer who has been living abroad since 2016. His nonfiction has been published by Euromaidan Press, Cirrus Gallery, and Our Thursday. Both his writing and his experience abroad are shaped by seeking out alternative lifestyles and counterculture movements, especially in developing nations. You can follow his travels through Eastern Europe and Central Asia on Instagram at @weirdviewmirror. He’s recently finished his second novel, and is in no hurry to publish it.