Clinical Research Associate Career Guide

What is a clinical research associate?

A clinical research associate (CRA) sets up, coordinates, monitors, and supervises clinical studies. They may work with new products or carry out clinical trials on existing products. Trials typically assess the safety and benefits of the product’s use. Most clinical research is conducted within pharmaceutical companies or contract research organizations (CROs) that conduct clinical research on behalf of pharmaceutical companies. Hospital departments also conduct studies on investigational products.

The CRA acts as the primary contact for doctors, researchers, laboratories, pharmacists, ethics committees, sponsors, clients, and other stakeholders. They ensure that the clinical trials are conducted as planned and that all risks and effects of investigational products have been fully examined and approved before the product is released on the market.

CRAs plan, coordinate, and supervise 4 different phases of clinical trials. Phase I involves testing the drug or treatment on a small number of people. If Phase I goes well, with little or no side effects found, they progress to Phase II, expanding the trial to a larger number of people. Phase III involves administering the drug or treatment to very large groups of people, where CRAs can collect vast amounts of data from a wide range of subjects. Phase IV begins after the drug or treatment has been approved by the FDA and involves post-marketing studies on side effects and effectiveness.  

Before the trial begins, CRAs select a site for the study and make sure the right equipment is on-site and the trial is set up properly. They may train doctors and nurses on proper procedures for the trial. During each phase of the trial, the CRA ensures that the site is conducting the study based on the sponsor’s requirements. CRAs typically visit the site throughout the study, but some also conduct virtual visits, to make sure the study is progressing smoothly. After the study concludes, the CRA verifies all paperwork and ensures all obligations have been met before drafting a final report for the sponsor.  

Some typical duties of a CRA include selecting, initiating, and monitoring trials to ensure they are being carried out according to applicable laws and regulations. They develop study procedures, methodologies, and instructions for clinical trial staff, and also design data collection tools. They manage inventory such as study supplies and medication supplies and ensure medication accountability. They verify collection data, write reports, and present results to the appropriate medical staff. CRAs keep a close watch on the safety and well-being of test subjects as well during a clinical trial.

Qualifications and eligibility

To become a CRA, you’ll need to have a bachelor’s degree, typically in the life sciences or a health-related field. Relevant subjects include biology, microbiology, medicine, pharmacology, immunology, and more. Some employers look for a master’s degree in clinical research or health science or a PhD. CRAs should have excellent computer skills, strong verbal and written communication skills, to deliver written reports and oral presentations, and good organizational skills. They need to be flexible as trials may need to be altered according to the collected data. They must possess a high degree of accuracy and integrity. Good knowledge of clinical practices and principles is also essential as is an in-depth understanding of statistical data collection, editing, validation, and analysis techniques.

CRAs need to be knowledgeable in federal and state guidelines for human trials. They need strong observation skills, computer skills, database skills, and attention to detail to monitor investigational product studies. Many employers look for CRAs who are familiar with the area of medicine or science that applies to the study, such as oncology or hematology. 

Work environment

CRAs work in a variety of settings, such as hospitals, clinics, pharmaceutical companies, contract research organizations (CROs), and biotech companies. Some are self-employed. They often work on several projects at the same time and may be required to frequently travel to the sites of the clinical studies. Their work can be stressful, especially when juggling multiple studies and working with deadlines. CRAs may be exposed to hazardous or physical risks and may be required to wear protective gear, including gloves and masks. They work with doctors, nurses, sponsors, and others while coordinating the trial and visiting sites to ensure all protocols are being followed. 

Typical work hours

CRAs typically work full-time during regular business hours, but they may occasionally work evenings or weekends depending on the research project or to attend meetings or complete paperwork. When traveling, they can be away from home for days at a time.  

Position trends

The U.S. Bureau of Labor Statistics projects that employment of medical scientists will grow 17% from 2021 to 2031, much faster than the average for all occupations. About 10,000 openings a year are projected for medical scientists. The rise in demand for medical scientists is due to more needed healthcare services as the population continues to age and rates of chronic disease continue to increase. Scientists are needed to research such diseases as Alzheimer’s disease and cancer, as well as issues related to the treatment of disease. Medical scientists will continue to be needed for medical research as more people are traveling and potentially spreading diseases to more places.