- Alexandra Steinberg

Term : May, 2015
Department : Biosciences
Program : Clinical Trials

When Alexandra Steinberg moved to California from Russia in 2009, she was a practicing doctor with both an M.D. and a Ph.D. Though she already had the academic credentials and experience, she wanted to transition into a career in clinical trials. She heard about UCSC Extension’s Clinical Trials and Design Management program through a friend and signed up for her first course, “Good Clinical Practices.” By the time she completed the certificate in less than two years later, she had shifted from a job-seeker position to a clinical trials coordinator, and further to the medical director of a Bay Area pharmaceutical company.

What drew you to the program?

Even though I had already had my M.D. and was done my Ph.D., UCSC Extension’s program was very beneficial for me. It made my career transitioning from practitioner to clinical trial research professional more smoothly. Back in Russia, I developed my medical and scientific expertise. However, I didn’t have detailed knowledge about the regulatory requirements for clinical trials, nor the operational parts of conducting a clinical trial. Taking the classes, I learned everything about conducting clinical trials in U.S. as well as internationally, including regulatory requirements, monitoring, safety reporting, etc. Basically, when I started my career in USA, the classes completed the whole puzzle for me, combining my medical knowledge and Ph.D. experience with operational and regulatory side of conducting clinical trials in the pharmaceutical industry.

What courses stood out to you?

I really liked the “Good Clinical Practices” and “Science of Clinical Trials Design” classes. Both of them were astonishing. “Good Clinical Practices” was the first one I took.  During the class, we covered the FDA regulations and ICH guidelines, and the instructor shared her own experience how these regulatory requirements work in real life. The “Science of Clinical Trials Design” class was a great adventure when we had a freedom be creative and to realize that there is no right or wrong way to design a clinical trial.  A lot of students do not like much the “Drug Development Process” class but I did like it. The class helped me to structure all knowledge I had about drug development starting from pharmacokinetics/pharmacodynamics aspects till freshly learned knowledge about GCP and safety. For me it was very refreshing. I felt like I was in my 20s again, studying all the time. These classes helped me to feel prepared for my career as a medical director. Even now, I still use some of my notes from the classes I took a few years ago.

How did you shift into a career in clinical trials?

When I started the program, I didn’t have work authorization yet.  As soon as I got my green card, I started looking for a job. I got my first job as a study coordinator. It was a great place to learn, and within a month I felt very comfortable at what I was doing. After three months, I got a position as an associate director/medical monitor at a pharmaceutical company. Now I’m a medical director at a different company. It’s a small company where I have to wear many hats. My responsibilities are to design clinical studies, to perform medical monitoring during the study conduct, i.e. to be responsible for safety of the subjects (from the sponsor prospective), to provide medical support to the study team, to review the data, so on and so on. The great thing is that I’m using the knowledge I learned over my studies and getting the experience on top of it, which make me feel satisfied with my career so far. It’s very creative work and I enjoy it every single day.

What advice do you have for professionals considering a career in clinical trials?

If you are looking for a job in clinical trials, take any position in industry or in the clinic who performing clinical trials, including volunteering. It’s good just to start being involved in the process. Go to as many networking events as possible, and bring a very attractive resume with you. When I meet someone who has not yet found their place, I give them the same advice I had four years ago: start taking classes, start looking for right volunteering position, and you will be there at some point in time. UCSC Extension required some investment but it’s worth it. People in the Bay Area know about UCSC and its programs, specifically about Clinical Trial Design and Management. When I went though interview process, interviewers often asked me about the program as many of them took at least one class from UCSC. When I am interviewing people now, and I see UCSC Extension on the candidate’s resume, it makes for a very nice start for the conversation. It’s a great program. I learned about it at the very right time in my career, and finished it in less than two years. I changed two jobs by the time I was done. It was very beneficial.

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