Getting into clinical research will allow you to get involved with research studies, some of which could lead to innovations that will profoundly improve the lives and health of millions of people.
What could be more fulfilling than that?
When we talk about clinical research, we are really talking about research conducted on humans, not on animals. As you may expect, when conducting research on humans, the study has to be conducted in a way that ensures the utmost safety of the participants.
When looking to the past, history is littered with human research studies that have been deemed unethical or dangerous. This is why the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) created an international set of guidelines for conducting clinical research on humans, which is aptly called Good Clinical Practice (GCP).
Both CRAs and CRCs utilize these guidelines in their daily jobs, so you’re going to have to start becoming familiar with them!
What Is a Clinical Research Associate (CRA)?
Clinical Research Associates (CRAs) are the individuals that work closely with the sponsors (the individuals or companies running the trial) and the clinical researcher or researchers who are the ones doing the day-to-day tasks of running the experiment. CRAs work to solve potential issues that arise when the investigation is underway, gather the data that has been collected, and, most importantly, ensure that the clinical trial is following Good Clinical Practice guidelines.
CRAs are responsible for looking out for the health of the human participants in the study and work with the study’s sponsors to ensure every party is satisfied with the study’s progress. CRAs may be asked to wear many hats, ranging from helping design the clinical trial to training the clinical researcher or researchers on the protocols needed to meet the study design guidelines.
How To Become a Clinical Research Associate
The most common way to become a CRA is to go to college and earn either a bachelor’s or master’s degree in clinical research or a related health field. The majority of individuals working as a CRA have at least a bachelor’s degree, although some only have an associate, although this is a little rarer.
Certification is also a sought after credential by future employers, which is offered by groups like The Association of Clinical Research Professionals (ACRP).
The essential requirement for those that have earned a bachelor’s degree in clinical research is 1,500 hours of professional experience before sitting for the exam. Those that jumped through the hoops to take this exam will sit through the 125-question multiple-choice test, which gauges test-takers’ knowledge of five categories of International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines.
What Is a Clinical Research Coordinator
Clinical research coordinators (CRCs) work in a different capacity than CRAs to make sure that a clinical trial runs smoothly. CRCs are responsible for the organization and coordination of the various parts that often happen simultaneously in a clinical trial.
Common tasks that you may find yourself performing as a research clinical coordinator include hiring the CRA, hiring and training researchers on how the clinical trial is to be performed, recruiting and ensuring the safety of human participants, and filling out various administrative paperwork associated with running the clinical trial.
While CRAs work more closely with the sponsor to ensure that the trial runs to the sponsors’ guidelines and satisfaction, the CRC is more closely involved with the research participants and the clinical trial’s everyday operation at the trial sites. For this reason, CRCs are more often located and work at the location that the trial is taking place, while CRAs are more likely to be found traveling to various site locations for their job.
How To Become Clinical Research Coordinator
Like the CRA certification, there is a CRC certification exam offered by the Association of Clinical Research Professionals (ACRP). There are multiple ways to meet the eligibility criteria to take the CRC certification exam, the most common of which is earning a bachelor’s or master’s degree in clinical research or a related field and gaining 1,500 hours of professional experience.
Those who have not earned a bachelor’s or master’s degree may still qualify for the exam in clinical research coordination if they have accumulated 3,000 hours of relevant professional experience.