The extensive process of putting a drug on the market starts with testing. Testing a drug’s effectiveness, risks and benefits are studied for years prior to a drug making it to market. These studies are often called clinical trials or clinical research trials. Individuals who run, administer and assist in overseeing the clinical trial are called clinical research associates (CRA).
Clinical Research Associates work on new drugs as well as drugs that are already on the market. Clinical research associates are usually employed by a pharmaceutical company or a contract research organization who works for the pharmaceutical company.
What are the Responsibilities of a CRA?
Being a CRA comes with a great deal of responsibility. While most CRA’s have assistants, most of the work that needs to be done is conducted by a Clinical Research Associate.
Some of these tasks include:
- Outlining the reason for the trial
- Presenting the trial protocols to a designated committee
- Coordinating with an ethics committee, who is there to protect the trial subjects
- Overseeing the facility that will be used for the clinical trial
- Hiring an investigator who would control the conduct of the trial
- Making sure that all trials have the necessary materials
- Making sure that the site is up to industry standards
- Collecting and documenting the test subjects’ medical and personal information
- Keeping track of all trial supplies
- Closing down the site after the trial
- Preparing reports after the trial and creating publications
What is the Work Schedule Like for a CRA?
For most CRA’s, the typical work schedule is 9am to 5pm, Monday through Friday. It is very rare that the trial would require that you work late into the night or on weekends. In some cases, travel is necessary, which would add to these hours. It is important to understand that some positions are local, and there would be no travel required. It all depends on the company that you are working for.
How Much Does a CRA Get Paid?
Like all jobs, the starting salary is going to be lower than the salary of an experienced CRA. The starting salary for a CRA is between $31,514 and $40,174. If you have a great deal of experience, you can start off at around $42,973. If you have been working as a CRA for a while, and are being promoted to senior CRA, you can get a large bump in your salary. People with these positions can earn between $48,703 and $57,298. If you are very experienced and are working for a large pharmaceutical company, you can make up to $85,974.
What Type of Educational Background Does a CRA Need?
In order to become a CRA, you would need the proper degree. It is possible to get your foot in the door without a degree, by starting out as a study site coordinator or a clinical trial administrator. In order to be promoted, you would need a great deal of experience working on a clinical trial. Even then, it could be difficult. The best way that a person can become a CRA is to have either a degree or postgraduate degree in medical sciences, life sciences, or nursing. An applicant would need to have studied the following subjects:
- Molecular biology
- Biomedical science
If you want to get a leg up on the competition, you should consider taking a postgraduate course in clinical research. Having a relevant PhD can also be very helpful when it comes to competing for a job.
What Skills Are Required to be a CRA?
Like any career, there are certain skills that a person should have to be a CRA, which are not necessarily taught in school but rather well honed overtime. Some of these skills include:
- Organizational skills
- Administrative skills
- IT skills
- Documentation and recording skills
- Written and oral communication skills
- The ability to motivate people and get them excited about the task at hand
- An excellent eye for detail
- The ability to think quickly
What Work Experience is Necessary to Land a CRA Job?
If you plan to get into the CRA field right out of high school, you would most likely enter the field at a lower level. You could start out being a clinical trials administrator or a clinical data coordinator. When doing these jobs, you would not be directly involved with the clinical trial. It can take a great deal of time to work your way up to a CRA position. Some smaller companies will recruit people right out of college, only if they have relevant personal skills. If you don’t want to start at the bottom, should get some job experience under your belt. You don’t need to be a doctor or a surgeon to get the necessary experience. There are a variety of jobs that you can take to get the experience that you need for a full CRA position. Some of these jobs include:
- Academic or pharmaceutical research jobs
- Work in a clinical laboratory
- Working with clinical data
- Medical salesperson
- Working in a pharmacy
The competition for CRA jobs is fierce. The more experience you have and the better your training is, your chances of getting a good position increase.
What are the Career Prospects for a CRA?
There are a few grades in a CRA career. Every company is different, and so is their career structure. The way most companies move their employees up is by judging their motivation, previous experience, and their ability to handle the job. Some companies require you to start from the bottom, regardless of education and experience. Some companies would require that you start off as a clinical trail administrator or a Junior CRA. Once you have worked your way up to becoming a full CRA, there are different levels that you can work towards, each with its own set of responsibilities.
- CRA Level I: As a CRA Level I, you would work on the pre-trial procedures. You would also work on setting up and organizing the clinical trials, under the supervision of a CRA Level II or Level III. You would also be responsible for archiving correspondence and documents.
- CRA Level II: This level position has many more responsibilities than a Level I. As a Level II, you would be responsible for the Level I CRA’s. You would also be in charge of selecting investigators, create and coordinate the ethics committee, coordinating the regulatory authority applications, attending investigator meetings, and supervising all of the trial supplies.
- CRA Level III/Senior CRA: This is the highest level possible. You would be responsible for designing case report forms, development of protocol, and complete project management. It is also the responsibility of a CRA Level III/Senior CRA to oversee, train, and mentor the junior staff, giving them an opportunity to accelerate.
A CRA has a great deal to do with treating and curing diseases. Without clinical trials, there would be no medications to treat conditions and cure diseases on the market. A CRA position is not just organizing trials. There is also science and public relations involved.
What is the Long Term Growth Potential?
The opportunities in this career path are nearly limitless. In the field of Clinical Research, U.S. and internationally, Clinical Research Associates and Coordinators are in high demand. This lucrative and viable career path has tremendous growth potential as the aging population of Americans lives longer.
Experts tout the Clinical Research industry as recession proof. The industry is expected to grow by 24% between 2008 and 2018. Roughly 26% of all jobs created in the US will be in the healthcare industry, in essence nearly 4 million new jobs. This sector is expanding far greater than any other industry and Clinical Research is up front and center.
Another sign of Clinical Research growing in popularity are the number of patents expiring and the immense need for pharmaceutical companies to renew their patents. Nearly 50% of clinical trials are conducted in the U.S. with Europe and India following at a close second and third respectively.
Although a voluntary process, Certification is one that is recommended for those looking to enter the field of Clinical Research. It showcases a professional’s ability to uphold ACRP/APCR Uniform Code of Ethics, shows they have met eligibility requirements and demonstrated proficiency in job-related skills.
Clinical Research Associates take the CCRA Exam (Certified Clinical Research Associate), which provides them with certification to showcase that they are trained and ready to proceed with being a part of administering clinical research trials. Several certifications and exams exist depending on what level of Clinical Research work you’ll be conducting. They are as follows:
- CCRA Exam: Certified Clinical Research Associate
- CCRC Exam: Certified Clinical Research Coordinator
- CPI Exam: Certified Principal Investigator
- CPRA Exam: Certified Pre-Award Research Administrator
- CFRA Exam: Certified Financial Research Administrator
It’s clear that Clinical Research is a medical specialty track that has long term growth potential not just in the U.S. but globally as well. Looking for a new career? Expanding in the field of healthcare? Look to Clinical Research as a career path and ask us how you can get started today!