Clinical Research Associate For A Pharmaceutical Contractor
Job Title: Clinical Research Associate (CRA)
Type of Company: My company is conducting a phase II clinical trial for a drug that's been approved overseas. I monitor the study to make sure that the subjects exist, the protocol is followed, and the side effects are recorded.
Education: BS, Applied Nutrition, Penn State University MS, Clinical Nutrition, New York University Registered Dietitian, Bronx Veterans Administration Medical Center
Previous Experience: I began working in hospitals as a registered dietician for AIDS patients. Later I cross-trained as a liver, renal, medical and ICU dietician. I started working as a research coordinator for a nephrology practice and then became a clinical research associate. First I worked for a contract research organization and I now work for a biopharmaceutical company.
Job Tasks: I brief and inform doctors, pharmacists and research coordinators on a study protocol that's been approved by an institutional review board (IRB). I'm the principal liaison: the person the site nurses call when there's a question about the protocol. But I do more than just sit back and answer phone calls. I travel to sites and read medical records to monitor the data they've captured, which includes demographic information, medical histories, laboratory results and side effects (or adverse events, as they're known -- these may or may not be related to the study drug or procedure). I write reports about my visit to the site and work with the site to resolve "action items." I review regulatory documents at the site. These mostly consist of CVs, licenses, and documentation that shows that people who are working on the study are well-versed in the details of the study's objective. IRB documents include the hospital or clinic's approval to conduct the study, annual review of the study, and submission of safety reports from the sponsor.
Best and Worst Parts of the Job: You have to love traveling. Depending on the job you take, you can end up traveling as much as three-quarters of the time. Contract CRAs generally travel the most and have higher hourly wages. I love that I have traveled to parts of the US that I would probably never have visited otherwise. I have a passion for food and enjoy eating local foods. Work days can be very long when traveling. There are weeks where I work in four different cities in one week. I enjoy doing different things every day and no two days are the same.
1. Work in a hospital to gain an understanding of the spectrum of diseases and of the medicines now used to treat them. Otherwise, you won't be able to review medical charts to capture possible side effects of the device or medication being studied.
2. Flex your flexibility muscles. If you like a structured, predictable work environment and don't like to work independently and travel alone, this job is not right for you.
3. Work as a research coordinator to understand the constraints and challenges of the job, prior to becoming a clinical research associate.
Additional Thoughts: My job is not as glamorous as people think when they hear that I travel. When I travel I work on site in a city for a full day and am not visiting a city as if I'm on vacation.
If I could change one thing about my career preparation, I would go back to school to be an RN, since opportunities for RNs are more numerous and the majority of employers prefer CRAs who are registered nurses. To be successful as a CRA you need to have a very good understanding of medical conditions, public speaking skills to train study staff, writing/computer capabilities and an ability to multi-task. Priorities and circumstances can change rapidly and you never know what to expect.