What are the School Requirements?
At minimum, you will need a Bachelor of Science degree in a field like biology, chemistry, or biochemistry or a four-year nursing (RN) degree. In addition to fulfilling school requirements, you will also need at least six months of clinical experience in pharmaceuticals, applied research, or related fields. If you have more advanced schooling, such as a master's degree, PhD, or MD, you can often get a job with less in the way of clinical experience. Generally speaking, if you want to become a clinical research assistant, the less education you have, the more employment experience you'll be required to have.
Important Job Skills
A clinical research assistant not only has to understand the science involved, but also has to possess excellent written and oral communication skills. As a research scientists right-hand person, you will take on a wide variety of tasks, from finding investigators to participate in clinical studies to writing grant proposals to making experiment protocols.
You will also be required to document procedures and results clearly and sometimes write them in the form of journal articles or technical papers for conferences. If the scientist you work for is also an academic, you could have tasks related to his or her school duties like assisting students with laboratory assignments.
As a clinical research assistant you will need a good grounding in statistical data analysis and the software commonly used to perform such analysis. Oracle Clinical is one such data management and statistical analysis software system. Employment experience with these analysis tools can be invaluable.
Knowledge of Clinical Ethics
The clinical research assistant also has as role in knowing the ethical rules and making sure that the trials that he or she works on stick to the regulatory and ethical standards that are spelled out by the U.S. Food and Drug Administration, the National Institutes of Health, and other regulatory bodies.
Professional Society Membership
Joining and participating in professional societies for people in your line of employment is a good way to show your commitment to your profession. For example, the Society of Clinical Research Associates holds conferences, facilitates networking between professionals and offers advanced educational and certification programs for research assistants to further their careers.
Be Persistent
Because there are a lot of people who want to be clinical research assistants and scientists can be quite selective in whom they choose it can be a hard field to break into. For that reason, it is likely that you will have to accept employment in a field that is related to what you do rather than your exact field of interest. In this competitive field, networking is extremely important as is furthering your school education through advanced classes and certifications. But as careers go, it is one of the most interesting and challenging.
Summary
The main task of the clinical research assistant is to monitor the execution of clinical trials. The clinical research assistant may work with the company sponsoring the trial, as an independent contractor, or for an educational research facility like a teaching hospital or university. People who become clinical research assistants must fulfill school and employment experience requirements and ensure that the research is carried out in strict compliance with the clinical trial protocol. This person must do meticulous evaluation of research experiments, including statistical research, case report forms, and communicating research results to professional conferences and journals.
In the United States, the clinical research assistant must have an academic degree in life sciences or nursing, be well versed in good clinical practice regulations as described in Title 21 of the Code of Federal Regulations. In Europe, the clinical practice regulations are contained in EudraLex, which govern medicinal products in the European Union.
