Clinical Research Associate – A Day in the Life

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. Pharmaceutical companies, universities, and health organizations put drugs through the clinical trial or clinical study process to obtain this proof. 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 offer financial aid for pharmaceutical development and biotechnology for agricultural and medical device industries.

In the case of pharmaceuticals, drugs that have not yet been approved for sale are administered to vetted participants in a controlled manner during a clinical trial. Clinical trials involve a great deal of documentation, analysis, observation, and organization. A team of professionals is engaged in administering 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 the clinical trial results must be kept entirely transparent and not influenced by the sponsor’s interests, this is a critical role. Therefore, a successful CRA will be detail-oriented, highly educated, and communicate clearly with both sponsors 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 good progress and record-keeping on the clinical site.

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

Typically, a clinical research associate does not have direct contact with the participants involved in the study. However, CRAs must work in a collaborative environment, coming into frequent contact with the clinical team at the study site and the supervisors from the study sponsor. Thus, 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 mainly dependent on the stage of the trial they are supervising. As such, below is a breakdown of the typical duties 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 appropriately 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 their 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 (mainly 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 their 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 appropriately set up to conduct the study. In addition, the clinical research associate conducts site visits at regular intervals throughout the study 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 methods 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 appropriate way to ensure the study progresses smoothly.

The CRA typically conducts a closeout visit after a study or when it becomes necessary to end a study—e.g., when enrollment is too low.

During the closeout visit, the CRA verifies that all paperwork is in order and that all obligations have been met on both sides. For example, the verification process may mean ensuring the trial drugs are returned or destroyed, completing and adequately 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 be 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 the sponsor and clinic understand their obligations at every point of the study. 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. For example, 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. Therefore, CRAs act as a vital monitor for ethical issues and should be able to stand up to any perceived transgressions.

Above all, it is essential that a CRA understands and can 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 ethically and effectively conducting drug trials with human subjects.

The ICH topics are divided into four categories: quality, efficacy, safety, and multidisciplinary. CRAs can find the guidelines in more detail on the ICH website. The YouTube Channel, GCP Mindset, outlines the different roles and responsibilities of CRAs. In short, upholding the GCP standards is the most critical part of the CRA job, meaning that any CRA must be familiar with GCP and recognize and enforce these practices in a clinical setting.

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

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 or
• Have a current CCRC, CPI, or ACRP-CP designation and be able to substitute 1,500 hours of work experience or
• Have completed a clinical research degree program and be able to substitute 1,500 hours of work experience

Applicants also have to submit proof of their current job description and resume and pass the CCRA exam. In addition, CCRAs must complete at least 24 hours of continuing education credits and be recertified every two years to maintain certification. Beyond the CCRA certification, ACRP also offers certifications for project managers, research coordinators, principal investigators, and 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 or 3,500 hours of part-time experience in the past five years
• 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 expressly certifies CRAs, while the SOCRA certification can apply to other 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.