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.

cra--Select `wp_mha_sb_school_data`.*, `wp_mha_sb_program_details`.* FROM `wp_mha_sb_school_data` JOIN `wp_mha_sb_program_details` ON `wp_mha_sb_school_data`.s_id = `wp_mha_sb_program_details`.s_id WHERE `wp_mha_sb_program_details`.p_degree = 'masters' AND ( `wp_mha_sb_program_details`.p_current_degrees = 'bachelors' OR `wp_mha_sb_program_details`.p_current_degrees like '%,bachelors,%' OR `wp_mha_sb_program_details`.p_current_degrees like 'bachelors,%' OR `wp_mha_sb_program_details`.p_current_degrees like '%,bachelors' ) AND ( `wp_mha_sb_program_details`.p_concentration_name = 'cra' OR `wp_mha_sb_program_details`.p_concentration_name like '%,cra,%' OR `wp_mha_sb_program_details`.p_concentration_name like 'cra,%' OR `wp_mha_sb_program_details`.p_concentration_name like '%,cra' ) AND ( `wp_mha_sb_program_details`.p_restricted_states <> '' AND `wp_mha_sb_program_details`.p_restricted_states NOT LIKE '%,,%' AND `wp_mha_sb_program_details`.p_restricted_states NOT LIKE ',%' AND `wp_mha_sb_program_details`.p_restricted_states NOT LIKE '%,' ) AND `wp_mha_sb_school_data`.s_active <> 'No' AND `wp_mha_sb_program_details`.p_accelerated = 'yes' AND `wp_mha_sb_program_details`.p_active_dpclickaway = 'yes' ORDER BY CASE WHEN `wp_mha_sb_program_details`.p_concentration_name LIKE '%cra%' THEN 1 END, CASE `wp_mha_sb_school_data`.s_id WHEN 54 THEN 1 WHEN 2 THEN 2 WHEN 25 THEN 3 WHEN 7 THEN 4 WHEN 26 THEN 5 WHEN 46 THEN 6 WHEN 13 THEN 7 WHEN 34 THEN 8 WHEN 9 THEN 9 WHEN 23 THEN 10 WHEN 16 THEN 11 WHEN 48 THEN 12 WHEN 15 THEN 13 WHEN 57 THEN 14 WHEN 22 THEN 15 WHEN 47 THEN 16 WHEN 61 THEN 17 WHEN 8 THEN 18 WHEN 49 THEN 19 WHEN 55 THEN 20 WHEN 5 THEN 21 WHEN 62 THEN 22 WHEN 27 THEN 23 WHEN 29 THEN 24 WHEN 58 THEN 25 WHEN 59 THEN 26 WHEN 21 THEN 27 WHEN 60 THEN 28 WHEN 50 THEN 29 WHEN 53 THEN 30 WHEN 30 THEN 31 WHEN 17 THEN 32 WHEN 1 THEN 33 WHEN 6 THEN 34 WHEN 32 THEN 35 WHEN 20 THEN 36 WHEN 56 THEN 37 WHEN 3 THEN 38 WHEN 10 THEN 39 WHEN 28 THEN 40 WHEN 33 THEN 41 WHEN 31 THEN 42 WHEN 52 THEN 43 WHEN 37 THEN 44 WHEN 39 THEN 45 WHEN 40 THEN 46 WHEN 41 THEN 47 WHEN 19 THEN 48 WHEN 18 THEN 49 WHEN 11 THEN 50 WHEN 45 THEN 51 WHEN 44 THEN 52 WHEN 42 THEN 53 WHEN 43 THEN 54 WHEN 24 THEN 55 WHEN 14 THEN 56 WHEN 12 THEN 57 WHEN 4 THEN 58 WHEN 38 THEN 59 WHEN 51 THEN 60 WHEN 63 THEN 61 WHEN 64 THEN 62 ELSE 99 END ASC, `wp_mha_sb_program_details`.p_name-/blog/day-in-the-life-of-a-clinical-research-associate
Featured Clinical Research Administration Programs
Arizona State University Clinical Research Management (MS) View Full Profile
Arizona State University Clinical Research Management - Regulatory Science (MS) View Full Profile
Arizona State University Regulatory Science (MS) View Full Profile
Arizona State University Regulatory Science (MS) - Food Safety View Full Profile
The George Washington University School of Medicine & Health Sciences MSHS in Clinical & Translational Research View Full Profile
The George Washington University School of Medicine & Health Sciences MSHS in Clinical Operations and Healthcare Management View Full Profile
The George Washington University School of Medicine & Health Sciences MSHS in Clinical Research Administration View Full Profile
Johns Hopkins University - Advanced Academic Programs MS Food Safety Regulation View Full Profile
Johns Hopkins University - Advanced Academic Programs MS Regulatory Science View Full Profile

THANK YOU FOR YOUR INTEREST IN Southern New Hampshire University Online MS - Construction Management

Work Environment of Clinical Research Associates

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.

Clinical Team of a Clinical Research Associate

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:

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.”

Typical Daily Responsibilities of Clinical Research Associates

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.

Before a Study Begins

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.

During a 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.

When a Study Ends

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.

Required Skills & Knowledge of Clinical Research Associates

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.

Certification for Clinical Research Associates

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).

Association of Clinical Research Professionals (ACRP) – Certified Clinical Research Associate (CCRA) Certification

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.

Society of Clinical Research Associates (SOCRA) – Certified Clinical Research Professional (CCRP) Certification

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
Matt Zbrog

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.

Related Posts

  • 15 April 2021

    A Day in the Life of a Clinical Data Analyst

    Every day, health organizations like hospitals, clinics, and physician offices collect data about their patients. This information is used to make data-driven decisions in order to provide the highest level of care to their patients as well as reduce expenses and errors. From the outcome of a particular treatment to a large-scale clinical trial, health data is a critical part of the modern healthcare process. Clinical data analysts help to make sense of the extensive data that is at their fingertips, creating stories that turn numbers into actionable intelligence to improve healthcare outcomes.

  • 10 July 2020

    Healthcare Debates: Does Costly US Healthcare Fund R&D and Medical Research?

    This article explores research and development in the context of greater healthcare expenditures, including looking into the main drivers of healthcare spending, influences on pricing, and where R&D fits into the whole ecosystem.

  • 13 November 2019

    Pharmaceutical Quality Director – A Day in the Life

    Consumers and corporations need to know that the drugs dispensed by pharmaceutical companies are manufactured safely and efficiently. Pharmaceutical quality directors ensure that quality control protocols are followed within the industry’s manufacturing, testing, and inspection procedures.

  • 20 February 2019

    Closing the Gap: Women Leading Healthcare

    Women drive healthcare. They are the industry's biggest consumers and workers. They serve as caregivers in their homes and make most decisions for their family's health. Why is it, then, that of the 40 Fortune 500 healthcare companies, not a single one is helmed by a woman?

  • 29 November 2018

    Clinical Application Analyst – A Day in the Life

    Electronic health records (EHR) and other clinical software systems are the new industry standard in healthcare. However, plenty of clinics, hospitals, and private practices have yet to make the full migration. That’s where clinical application analysts come in.