It’s a funny story of how Marianna Lenoci began teaching at Extension.
About 10 years ago, she found herself at a place in her career where she wasn’t advancing. Should she explore a career shift? Would additional education give her the needed bump? After some online searching for next steps, Marianna found herself attending an in-person information session for the Certificate Program in Clinical Research Conduct and Management.
“At the time, I had been working in clinical research for a fair amount of time and had a lot of experience working at a clinical trial site and in academia,” Marianna remembers. “I thought, ‘This information session was perfect. I’m going to network and then take classes or the full certificate.’
“I met with the program director, and we talked about whether or not the certificate would be appropriate for my career path,” she continues. “There were some parts of the curriculum that I didn’t know, and there were some parts of it that I knew really well—well enough that I could probably teach it. And she was thinking the same thing! So I came in the door as a prospective student and left as an instructor.”
Ten years later, Marianna keeps that former self in mind as she instructs future clinical researchers. I recently had the pleasure of talking with Marianna, and you’ll see why she’s one of our 2018 Honored Instructors.
What types of students enroll in your courses?
It’s a spectrum.
On one end, we have students who have been in the industry and are looking to enhance their knowledge and develop their careers. On the other end, we have students who are searching for their next career. And then we have students in the middle, some of whom have no science background but are really interested in clinical research.
Today, the majority of my students are career-seekers. I also have a lot of international students who have extremely strong medical backgrounds—many of them are physicians. They relocate to the U.S and are exploring their available career paths.
Has your teaching adapted to the influx of career-seekers and international students?
Earlier, a lot of my teaching was lecture-focused.
Now, I find myself allocating more time to spend with each student. That has enhanced the learning environment, and it’s more pleasurable for me to have that time with each student—to understand what they need in the classroom, why they’re there, what they’re contributing to the classroom so I can accentuate that strength in the classroom.
It also allows me to know what their gaps are and where they want to go so I can help them with their career path and get them bridged to the right people.
We still have lectures and mix in group exercises and hands-on work. Part of their grade includes attendance and participation, and I tell them that I know if you’re not here—you can’t hide!
Why do you enjoy teaching adult learners?
They choose to be here; they really want to be here. They are so much more attentive and dedicated and committed. They’ve got much more life experience that they bring into the classroom and share with the other students. It’s a win-win situation.
We all love what we do and also know the importance of being a mentor and a resource for the students as they start to explore their career options.
In your view, how does our certificate prepare students to enter the clinical-research workforce?
A lot of employers are looking for hands-on experience, yet you need a job to get hands-on experience—that’s the Catch-22. It’s competitive out there, but that’s the gap our certificate fills: We are providing instruction, giving some hands-on work in the classroom, teaching them the applicable regulations and providing them with good clinical-practice concepts so they can become more competitive candidates. It hopefully gives students that advantage.
As students move into the last phase of the certificate, that’s when we tend to focus on careers, résumés and interviews. The program director is always on the search for internships for our students. My fellow instructors and I are on the lookout as well, and when we find one, we let each other know so that the information can be spread to all of our students and graduates.
That’s the community the instructional team has established in this certificate. We all love what we do and also know the importance of being a mentor and a resource for the students as they start to explore their career options.
Everything I’m teaching I do every day—everything.
You also prepare your students by providing insights from your own professional experience.
Right! When I first started teaching, I was working in clinical research at the San Francisco VA Medical Center, investigating post-traumatic stress disorder. I spent 15 years conducting clinical trials for lead investigators, and that’s when I attended that information session.
For the past seven years, I’ve been working at Gilead Sciences. At first, I was in clinical operations, running and managing clinical research trials. In the past two years, I’ve moved into regulatory compliance. My main focus in compliance is ensuring that the clinical trials are in alignment with the applicable regulations and Good Clinical Practices (GCP). I’m heavily immersed in research ethics. Every day, I field GCP questions from our operations teams. I also visit the clinical trial sites and our vendors to conduct compliance audits and support regulatory inspections.
All along the way since I’ve started with UC Berkeley Extension, everything I’m teaching I do every day—everything.
As such, I feel obligated to keep my finger on the pulse of what’s happening in the industry so I can continuously bring that information into the classroom and keep the students up to date. It’s also caused me to be much more up to date in my work environment.
What better way to teach something than through practical applied learning? I’m bringing examples from my work into the classroom, providing stories or scenarios as we’re going through lectures.
I encourage the students to be curious, ask questions, express their opinions.
With your finger on the pulse, what new trends are you excited to see?
I’m a regulatory nerd [laughs]. From a compliance or a human subject–protection perspective in pharmaceutical trials, some of the regulations are changing. The ICH Good Clinical Practices guideline recently received an addendum. The guideline has been in existence for quite a while, and this is the first time a change has been made. Now, it’s emphasizing a quality focus and risk-based approach—which a lot of us were already doing, but now it’s expected.
From an international perspective, there are more steps to protect subjects’ privacy and confidentiality—especially in Europe. You’re also seeing more emphasis on protecting not just the subjects, but also the data. These are the foundations of doing clinical research: protecting subjects and data integrity.
I think it’s safe to say that you love your work and teaching.
I always put myself in the shoes of the student and want to keep them engaged during the full-day class. I like an interactive classroom; I encourage the students to be curious, ask questions, express their opinions.
These are students who sometimes are at a crossroads in their life and they’re trying to find a new career. The certificate program creates a community for them. They meet others who are going through the same thing. Not only do they network, but they also have support. There are communities that are built in that classroom beyond what we’re teaching.
I always say I have my job and then I have my love: teaching at Berkeley. It’s a passion of mine, and I’m grateful to have this.