The life of a clinical research associate (CRA) was taxing enough before COVID-19 struck and complicated everything to a very significant degree. Now, these people on the front lines of studies are charged with keeping the important work of clinical trials going, facing the usual challenges of CRA life and the obstacles that the virus has piled on in addition.
Marne Baca (MB), senior CRA with Rho, recently took time out of her busy day to talk with Outsourcing-Pharma (OSP) about what motivated her to enter the field, how COVID-19 has impacted studies, and what she enjoys most about her job.
OSP: Could you please share an overview of your career—what career dreams did you have as a youngster, how did you get into science and research, and what path did your career take to bring you to Rho in this role?
MB: As a child, I was drawn to the arts much more than the sciences, so it was a surprising career choice for me and one that I initially stumbled upon. After graduating from college, I worked in software but never really felt a tremendous connection to or sense of purpose with the work that I was doing.
The transition to my current career was certainly a slow one. I started working in patient advocacy, which helped me understand the critical nature of drug therapies for those who live with a chronic and progressive disease. I also had an opportunity to work at an academic research center, first as a study coordinator and then as a research program manager.
These experiences helped me understand how clinical research is conducted at a site level. Ultimately, I transitioned to working in a CRO environment, where I held several positions before becoming a CRA.
OSP: What do you enjoy most about your job, and what aspects (if any) do you not enjoy so much?
MB: I am a “big picture” person and highly motivated by the idea that working on critical therapies could potentially make a huge difference in someone’s life. When I am having a tough day, I try to remind myself of the ultimate goal; I also like the actual day-to-day work, especially in site management where I can really partner with staff in working with data and reviewing source.
I am also interested in how a protocol is operationalized across multiple sites; for example, large hospitals have different challenges than smaller independent research facilities. Some of the things I don’t necessarily love are travel delays and flight cancellations!
OSP: Is there such a thing as a typical day for you? If so, please describe what it might look like.
MB: In my monitoring tasks, I’m primarily conducting a mix of data and protocol compliance reviews, as well as drug accountability and regulatory reviews. There is also perpetual report writing – monitors are always working on reports.
No two days are exactly the same for me. I can start the day with a list of items to accomplish and an unexpected issue may arise, rapidly changing my initial plans. For example, I would have to quickly shift gears and respond to certain issues like site reporting a serious adverse event or a power outage that impacts an investigational product. All in all, flexibility is key.
OSP: If you could, please think back to how your work changed in the weeks/months leading up to when the COVID-19 pandemic shook everything up. Could you please share what kinds of concerns first popped up when you and your colleagues started in earnest discussing how to deal with it?
MB: Initially, there were so many questions about safety. On my study at the time, we were fortunate to be able to work with the sponsor to develop a plan for remote monitoring in order to keep the work moving forward.
We also conducted a site assessment survey prior to activating locations for the study, in which we asked about COVID-19 risk mitigation procedures and continued to monitor for changes to plans and procedures. For example, some sites immediately prohibited on-site monitoring. Some of those restrictions have loosened, but there are still a number of locations that will not allow monitors on site.
OSP: Please share how you and your colleagues brainstormed and came up with solutions to keep trials going. What specific problems did you tackle, what worked, what didn’t, etc.?
MB: Monitoring has typically been conducted on site, involved travel and contact with many people – exactly what you try to minimize during the COVID era. Our team pivoted to a model that allowed for remote monitoring and had to address necessary tools to conduct the work safely and efficiently.
We also had to elicit cooperation from site teams to redact, certify, scan, and upload source documents into Rho’s proprietary portal. I learned that it’s extremely challenging to transition from an existing monitoring model and reinvent your operations during the course of a study. Again, it’s all about flexibility.
OSP: Fast forward to now, in 2021. What is different about your job (day to day and long term) from pre-COVID days, and what (if anything) has stayed the same?
MB: These days, I monitor both remotely (and get to have my dog as coworker – bonus!) and onsite, although with many precautions (e.g. PPE, working in a restricted space with limited staff contact, testing prior to arriving onsite, etc.). I’m careful with travel and try to select less crowded flights whenever possible. I’ve also been a fan of double-masking long before the CDC recommended it!
OSP: Can you think of any important lessons the pandemic has taught you?
MB: I try to take nothing for granted. I make frequent gratitude lists, and I find this practice to be a useful tool in helping to recalibrate my attitude. My appreciation of being outside also grew – walking, running, and hiking in nature have been critical to my health and well-being during the pandemic.
OSP: Imagine one of the readers looking over your words right now is a college student or recent grad thinking of getting into clinical research, as a CRA or a similar position. Can you please share some advice to this person as they’re embarking on this new career?
MB: I would encourage them to safely work at a site to gain experience and appreciation for study conduct prior to entering the CRO world. Also, one of the best ways to determine if this is the right industry for you is to talk to as many people within the industry as you can about their work. People typically love to talk about their jobs.
I also recommend finding a mentor, even if informally. It is a great way to understand the various paths to growing professionally within the industry.