When you start a new job, decide on a career path, or want to learn more about an industry, the job titles, acronyms, and industry-specific language can be confusing!
This certainly holds true in Clinical Research. For job titles alone, we often hear CRA, CRC, CTM, CTA, PI, Sub-I, DM, and many other acronyms, which can overwhelm a new research professional.
Beginning with the acronyms, CRC stands for Clinical Research Coordinator, and CRA stands for Clinical Research Associate. The titles sound as though they could be interchangeable, but knowing the job duties and qualifications will make it easy to differentiate between the roles.
CRCs and CRAs work together on a research team, and although their roles sound similar, there are profound differences, including educational requirements, patient involvement, and salary.
Since CRC and CRA are two job titles in Clinical Research that you hear about most and need clarification on, this article will discuss each role and what makes them different.
What does a CRC do?
A Clinical Research Coordinator, also called a Clinical Trial Coordinator or Study Coordinator, works at a research site under the Principal Investigator’s (PI) supervision. CRCs engage and work with patients and directly support, facilitate, and organize clinical trial activities across one or more trials at their site.
Characteristics of successful CRCs include exceptional communication and interpersonal skills, the ability to multi-task and stay organized, and being naturally analytical, willing to learn, curious, and empathetic.
Those who exhibit all or most of these personality traits may be better equipped to take on the key responsibilities that come with the CRC role, which typically include the following:
- Planning and managing the study by creating source documents, maintaining organization, filing, etc.
- Enrolling patients in the study by finding qualified individuals, sharing study information, providing answers to questions, and performing study visits according to the protocol, including laboratory sample collection and processing
- Maintaining patient enrollment by building relationships, communicating, following up, answering questions, and being the patient’s primary contact
- Training staff or patients on study-specific parameters and other important study-related procedures
- Maintaining accurate records of study drugs and study supplies
- Performing data entry into study-specific systems
- Staying in compliance with the study protocol as well as federal, state, and institutional regulations
- Working closely with cross-functional teams involved with the study and the CRA, who in turn works with the Sponsor or Clinical Research Organization (CRO)
The Association of Clinical Research Professionals (ACRP) created a list of Core Competency Guidelines for Clinical Research Coordinators to use for self-assessment, analyzing gaps in competence, and creating professional development plans.
Clinical Research Coordinators generally do not travel. Most CRC roles are in-person at a research site. There are various levels of the CRC role that are typically based on years of experience. Each company is different, but titles may include Assistant CRC or Research Assistant, CRC 1, CRC 2, and Lead CRC. A natural career progression for a CRC is to the CRA role.
PRO TIP: If you are interested in learning more about the Clinical Research Coordinator job, a straightforward way to find information is by reviewing job descriptions on a job search website like Indeed.
What does a CRA do?
Clinical Research Associates (CRAs) are the liaison between a Sponsor or CRO and the research site(s) for the clinical trial.
CRAs play a crucial role in clinical trial monitoring, which is when a CRA visits a site to interact with the PI and Clinical Research Coordinator and confirm the study protocol and other regulations are being followed. A monitoring visit is jam-packed as the CRA is responsible for reviewing patient data and site study files, confirming patients meet eligibility requirements, inventorying study supplies, including study drugs, answering questions from the site, implementing action plans and training (if needed), and much more.
CRAs do not interact with trial patients.
Along with monitoring, other critical parts of the CRA’s role are:
- Effective communication
- Ability to problem-solve
Most Clinical Research Associates are involved with multiple clinical trials at a time and can manage 10 – 15 sites on average per study. A CRA’s typical daily responsibilities differ depending on the clinical trial stage. In this article, you can read more about what a CRA does during each phase.
The best CRAs are excellent communicators with top-notch interpersonal skills, excel at relationship building, are highly motivated and good at motivating others, and are detail-oriented, organized multi-taskers.
The ACRP created this Core Competency Framework for Clinical Study Monitoring that CRAs can use as a reference for their job expectations and performance.
CRAs generally travel to assigned sites for monitoring approximately eight to ten days per month. Most CRAs work out of a home office when they are not traveling.
There are several levels of the CRA role, and they vary by company. Common titles include CRA 1, CRA 2, Senior CRA (Sr. CRA or SCRA) 1, Sr. CRA 2, Principal CRA, Lead CRA (LCRA), and In-House CRA (IHCRA).
- A Principal CRA typically oversees the CRAs assigned to a project while maintaining all their CRA responsibilities. A person may take on this role if they are not interested in becoming a Clinical Trial Manager (CTM).
- A Lead CRA often takes on some CTM duties but also retains some of their CRA responsibilities. LCRA is a hybrid role between the CRA and CTM, but an LCRA is interested in becoming a CTM in the future, so this role serves as a bridge. A person in the LCRA role may be a trip report reviewer, the lead CRA trainer, a point of escalation for the CRAs when traveling, a reviewer of study metrics, and a chair of CRA team meetings.
- An In-House CRA does not travel and usually works for a Sponsor or CRO in a more administrative role. A person in this role typically supports traveling CRAs by assisting with action item closure and site follow-up and may be gaining experience to become a CRA or CTM.
A natural career progression for a CRA is to the Clinical Trial Manager role.
What are the differences between the CRC and CRA roles?
The Clinical Research Coordinator and Clinical Research Associate roles are different. However, because there can be some overlap, here are four key differences between a CRC and a CRA.
- CRCs and CRAs have different educational requirements.*
A Clinical Research Coordinator can be an entry-level position. A high school diploma or GED is required for the CRC role. Zero to two years of Clinical Research experience is ideal but not always mandatory at some research sites. A college degree is not a requirement; however, a four-year bachelor’s degree in a health-related field may be helpful for CRCs who want to continue to level up in the industry. Knowledge of medical terminology, Good Clinical Practice, ALCOA-CCEA, and ICH Guidelines are essential for a CRC.
A Clinical Research Associate is not an entry-level position within the Clinical Research industry. A Bachelor’s degree in a health-related field, including clinical research, health science, or biological science, is typically preferred. In addition, a minimum of 1-2 years of field-based monitoring or other relevant experience is a requirement of CRAs by most employers.
A natural career progression for a Clinical Research Coordinator is to the Clinical Research Associate role. Experienced CRAs often transition to the Clinical Trial Manager role.
*The information in this section is typical for CRCs and CRAs, but requirements may vary between companies.
- Employment specifications for CRCs and CRAs are not the same.
CRCs work for a research clinic at the site level and typically report directly to the Principal Investigator (PI). CRCs work in person at the research clinic or trial site.
CRAs are often employed by a Pharmaceutical Company or through a Clinical Research Organization (CRO). In addition, some CRAs work as independent contractors. CRAs commonly work from a home office and schedule monitoring visits with their assigned sites.
Another difference is the working relationship with the PI. For example, the PI supervises the CRC, whereas the CRA’s job is to ensure the PI complies with the research protocols.
- CRCs and CRAs have different roles with trial participants and data collection.
Clinical Research Coordinators interact and work with patients directly. CRCs are involved with recruitment, scheduling patient visits, and collecting patient data.
CRAs do not interact with trial participants but ensure that enrollment standards are met. Rather than collecting data, CRAs monitor the data collected with a focus on data quality and patient safety.
- The salary for CRCs and CRAs can be a differentiating factor.
In general, a CRA typically receives a higher salary than a CRC. Of course, there are exceptions, but due to a Clinical Research Associate’s educational and travel requirements, their income is generally higher than that of a Clinical Research Coordinator.
Many individuals join the Clinical Research industry as CRC, and the increased salary is a motivating factor when trying to move to the CRA role.
What are the similarities between the CRC and CRA roles?
The most important similarity between a Clinical Research Coordinator and a Clinical Research Associate is that both roles are essential to a research study. Their involvement is integral to the success of a clinical trial.
CRCs and CRAs must be organized, effective communicators who are good at multitasking and passionate about Clinical Research.
CRCs and CRAs are often called the “backbone of a clinical study.” While both are valued roles that carry intense responsibility, the focus is different: CRCs focus on patient-related activities, and CRAs focus on study monitoring.
As Clinical Research team members, CRCs, and CRAs can help increase their teams’ efficiency and lead them to more studies that conclude on time, within budget, and produce quality results.
Many CRCs and CRAs love using the time-saving tools and resources from ClinEssentials to help them do their job well in less time – take a look at the Shop!
Next Steps for Aspiring and Current CRCs and CRAs
If you want to enter the Clinical Research industry with an entry-level role, the Clinical Research Coordinator role may be something to read more about. If you have some experience, the Clinical Research Associate role may be a good fit. If you want to become a Clinical Trial Manager, download this FREE guide about transitioning to the CTM role.
While you can find plenty of information about CRCs and CRAs online, talking to someone with industry experience is sometimes more helpful. ClinEssentials has a Career Services program designed to help with career advice, professional development, resume reviews, and more! Click here to schedule a consultation.
What other questions do you have about CRCs versus CRAs? What other Clinical Research roles would you like to learn more about? Please comment below!
Tiffany Ashton, MAS, CCRA, has over twenty years of experience as a Clinical Research Professional. Tiffany is the Director of Operations for ClinEssentials, a consultant in the Clinical Trial Manager role, and the expert instructor for the CTM Training Course.