Alisha Bouge graduated with a Master of Science in Biomedical Regulatory Affairs from the University of Washington in 2011. She now works as an institutional review board education specialist at Stanford University, where she helps educate faculty and staff on regulations to protect human participants in research. Here, Alisha discusses how the master's program helped prepare her for her career path.
How has your experience in the master's program helped you in your current position?
The master's program gave me a great foundation to build from, and I rely on all that knowledge in my current job in regulatory compliance. I work as an IRB education specialist for the Research Compliance Office at Stanford, which oversees the approval of human subject research at the university. My position focuses on training and education – I make sure that everyone is up to date on policies and federal and state regulations.
What did you enjoy most about the program?
The course selection was very interesting. You'd have technical writing, then clinical regulations and then you'd take more of an engineering type of class. The diversity of classes helps you see all the different elements that go into this field, whether it was writing, design, administrative or practice skills, such as the proper way to deal with human subjects in research. Getting the bigger picture was a huge lesson.
What skills did you learn that you find particularly useful in your job?
During the master's program, I was integrated with students from a variety of different professional backgrounds. We came together to work as a team to finish our assignments.
At Stanford I also work with a variety of different people. I am constantly getting calls from researchers, research coordinators and sometimes research participants. I need to be able to ask the right questions and make sure I'm getting them the correct information so that everyone is well informed and things are done in a timely manner. I don't think I would be as comfortable in this type of position without going through that teamwork experience in the master's program.
Can you tell us about your practicum project?
My practicum involved the preparation of an investigational new drug submission to the Food and Drug Administration. It wasn't technically a new drug – it had already been approved by the FDA – but it was for a new population, and a new indication. I helped prepare the IND [investigational new drug application] and submit it to the FDA.
We got a report from the FDA and it came full circle before the end of the class. It was extremely useful to see from beginning to end how the process worked.
How has the practicum experience helped you in your current job?
I'm not on the research side anymore, but I'm helping to ensure that research is done according to the regulations. So I need to understand the basics of research to help facilitate my job – I need to ask researchers the right questions and make sure we have the documentation they need to do their studies.
Do you think having a master's degree has helped your career?
In this field, the higher you'd like to advance, the more knowledge you need. For the regulatory aspects of my job, I built that knowledge through my graduate program. I don't think I would have the job I do without my master's degree.