Clinical Research Associate How to become, career path, income potential

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.  

Types of clinical research associates

CRAs coordinate and supervise different types of clinical research depending on what they are studying. There are typically 9 recognized types of clinical trials. Below are the types of trials a CRA may be involved in: 

Treatment research

Treatment research typically involves testing a medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy. 

Prevention research

Prevention research investigates better ways to prevent disorders from developing or returning. CRAs may look at medicines, vitamins, vaccines, minerals, or lifestyle changes in the trial.

Diagnostic research

Diagnostic research focuses on how to identify a particular disorder or condition so it can be treated. 

Screening research

Screening research attempts to find the most effective ways to detect certain disorders or health conditions in the human body. 

Quality of life research

This type of research looks at ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies

Genetic studies seek to improve the likelihood of discovering disorders by identifying and understanding how genes and illnesses may be related. CRAs identify a person as being at risk of a particular disease or disorder and find ways to prevent the disease from manifesting. 

Epidemiological studies

Epidemiological studies find patterns, causes, and how to control disorders impacting large groups of people. 

Income potential

The earning potential for a clinical research associate can vary greatly depending on geographic location, education, experience, and area of research.  

  • According to the U.S. Bureau of Labor Statistics, the median annual wage for medical scientists was $95,310 in May 2021. The lowest 10% earned less than $50,100, and the highest 10% earned more than $166,980. In May 2021, the top industries in which medical scientists worked were:
    • Research and development in the physical, engineering, and life sciences – $102,210
    • Pharmaceutical and medicine manufacturing – $99,830
    • Hospitals; state, local, and private – $79,800
    • Offices of physicians – $79,760
    • Colleges, universities, and professional schools; state, local, and private – $62,560
  • The 5 states with the highest annual pay for clinical research associates are:
    • Washington – $93,030
    • New York – $87,533
    • California – $84,059
    • Idaho – $83,572
    • New Hampshire – $82,731
  • The bottom 3 states are:
    • Georgia – $61,328
    • Louisiana – $59,689
    • North Carolina – $57,429

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.

Career path

A CRA has several career path options in clinical research. You can work for different types of employers such as pharmaceutical companies, biotech firms, medical device companies, or CROs. The three main paths for career advancement for CRAs include:

Clinical trial management

The clinical trial manager typically plans, coordinates, and oversees various aspects of a trial. They generally supervise the staff, create study documents and implement tools needed for the study, and manage trial budgets.

Clinical team management 

A clinical team manager is responsible for managing the CRAs working on clinical trials. They support team members, ensure the staff is well trained, evaluate the effectiveness of business processes, and plan professional development activities.

Clinical project management

Clinical project managers plan and supervise clinical trials. They are responsible for the collection and evaluation of clinical data. They typically maintain records of the study and ensure that deliverables are provided on time and on budget. They interpret study data and write reports on findings. 

With further experience, CRAs can advance to other positions, including clinical director or VP of Clinical Trials.

Steps to becoming a clinical research associate

1. Get your bachelor’s degree

To become a CRA, you’ll typically need a bachelor’s degree in the life sciences or a health-related field. Popular majors include health sciences, nursing, medical technology, and biological sciences. A degree in sociology or psychology can also be beneficial in laying the groundwork for research insights. 

2. Get experience in a clinical research setting

Most employers want entry-level candidates for CRA who have some experience in the field. You can gain experience through volunteering or finding part-time work in a laboratory. There are also internship opportunities, many of which you can find out about through your university. You might also find a fellowship opportunity to assist with research.

3. Consider getting an advanced degree

While not necessary for most positions as a CRA, completing a master’s degree or a doctorate can help you qualify for management or supervisory positions. 

4. Get your certification

To become a CRA, you don’t need to be certified, but it can help set you apart from your peers when applying for jobs and when opportunities for promotions become available. Two organizations offer certifications for CRAs: 

  • The Society of Clinical Research Associates (SOCRA) – The SOCRA offers the Certified Clinical Research Professional (CCRP) credential. To earn this certification, you must have one of the following:
    • At least two years of clinical research experience or 3,500 hours of part-time experience in the past five years as a clinical research professional.
    • A degree in clinical research and at least one year of full-time experience as a clinical research professional.
    • A certificate in clinical research, a bachelor’s or associate degree in health science, science, or a related field, and at least one year of full-time work experience as a clinical research professional.

To become certified, you must pass the CCRP exam. The credential is valid for 3 years, after which you will need to be recertified. For recertification, you must complete 45 hours of continuing education. 

The ACRP certifications only certify clinical research associates, whereas the SOCRA CCRP certification applies to other types of clinical research professionals.

5. Join associations

Joining an organization can open up a wealth of resources, networking opportunities, and job opportunities for you. Here are some of the top organizations for clinical research associates:

Tips for becoming a clinical research associate

If you are planning to become a clinical research associate, there are a few things that can give you the edge you need. Here are some tips for becoming a clinical research associate:

  • Take all the science classes you can while in high school and determine whether you have the aptitude for undergraduate study in the life sciences or the medical sciences. These curriculums aren’t easy, so it’s important to decide early on if this is a career path you have a desire and aptitude for.
  • Develop data management and data analytics skills. You can volunteer, find internships, or even look for paid opportunities that will help you hone your skills. 
  • Be aware that a CRA often is working under pressure to meet deadlines and conform to regulations and policies. The job can be stressful at times.  
  • Work on your interpersonal skills. CRAs work with a wide range of stakeholders during clinical trials and need to be able to communicate effectively with all of them.
  • Understand that typically a lot of travel is involved, and make sure you are comfortable being away from home for days at a time.  
  • Think about what type of company, and what type of clinical research, you’re most interested in. Clinical research offers many opportunities with different types of companies and job opportunities. You might want to work for a CRO, a pharmaceutical company, a clinical research vendor, or the U.S. Food and Drug Administration. Know your options and where you want your career to go. 
  • Consider that you may have to relocate to a different city, state, or even country for the job you want. 
  • Think about whether you want to get an advanced degree that can help you land a higher-level position. The time investment can be from 2 to 8 years, so you’ll want to be committed to it.

Clinical research associate interview questions to expect

  • What are the different phases of clinical trials?
  • What HIPAA regulations are important when you’re handling a research study with minor children? 
  • What do you do if a subject experiences an adverse reaction during a trial?
  • What would you do if you found a discrepancy in a subject’s medical records?
  • How familiar are you with the statistical analysis of clinical trials?

Clinical research associate FAQs