Clinical Researcher—October 2022 (Volume 36, Issue 5)

ON THE JOB

Elizabeth Weeks-Rowe, LVN, CCRA

 

Innovation is the strongest voice in the developmental narrative of clinical research. It drives adaptive study design, advanced data collection/reporting, and alternative research methods to ensure business continuity in times of crisis.

Innovative technologies have transformed the landscape of clinical research forever, including through revolutionized data collection practices with the advent of systems for electronic data capture (EDC), electronic patient-reported outcome (ePRO) measurements, and electronic source/regulatory capabilities.

Early EDC systems helped reduce the need for paper case report forms and associated data collection measures that were slower, less efficient, and less accurate. Those early systems, self-contained and archaic by today’s standards (anyone remember lugging the extra EDC laptop to monitoring visits?), still revolutionized data efficiency and accelerated data transmission. EDC systems have since evolved to web-based/cloud-based technology that incorporates automated review to track data discrepancies, issues, and questionable reporting trends at the site/patient level and across trial centers. These systems can be accessed by many users at any place with a secure internet connection.

ePRO technology helped facilitate early patient centricity initiatives by providing patients more accessible and streamlined tools for personal reporting of trial endpoint data (e.g., eDiaries, pain reports, and quality of life questionnaires) and embedding their voices in early trial outcomes.

Innovative regulatory portals accelerated regulatory start up and submission timelines to meet the critical need for effective vaccines during the pandemic. Meanwhile, innovative platforms (e.g., Zoom, Microsoft teams) transformed an antiquated monitoring process into a more accessible, transparent, and accurate methodology (remote/virtual monitoring) that enables real-time data access, review, and site/contract research organization (CRO) communications.

A New Era for Innovation

Innovation has heralded a new era in which talent, work ethic, and transferable skills are the differentiating factors in job consideration. Diversity—both in terms of ideas and background—is truly valued as an element of one’s contributions to an organization, as opposed to being a rote consideration that is often dismissed as being necessary to satisfy a quota.

Innovation is wrought by visionaries—trail blazers with the alacrity/vision to anticipate potential crises and successfully and quickly adapt to forestall them, as opposed to accepting chaos as the forced catalyst for change. Some of these visionaries are gifted women who may have once been underestimated and unrecognized for their talents.

Featured here are insights from women in clinical research who have used creativity and ingenuity to forge a passageway through a once-impenetrable career ceiling by crafting alternative curriculum and training delivery for broader access during the pandemic, or blazing a path over barriers to site ownership, or fueling their ambitions across a career trajectory from clinical research associate to CRO director in less than 10 years. All of them have challenged the status quo and had a remarkable impact on the clinical research enterprise.

Lauren Ballina Chang, MS, CCRP

In her role as vice president of strategic growth with Clinical Research Fastrack’s boot camp–style of training organization for new clinical researchers, Chang has an inspirational career story involving an innovative pathway to leadership. She explained that “as an educator, mentor, innovator, entrepreneur, and clinical research professional, creativity has been the most unexpected asset in my skillset arsenal.”

Chang started and grew her career at the site level running primarily investigator-initiated trials. She had an early introduction to the constant problem-solving/pivoting that made the job engaging, rewarding, and interesting. Though she loved working at the site level and being patient-facing, she truly found her passion helping others start their careers in clinical research.

Now part of the leadership team at Clinical Research Fastrack, she is always evaluating the research field for trends and finding new ways to help aspiring clinical research professionals seeking training. She describes the incredible shift forced by the pandemic to ensure business continuity: “Until COVID hit, all our trainings had been delivered in person in a physical classroom setting. As the world shut down, there was a moment of panic—was this [the end] for our training organization?”

Describing how the company’s team responded with the innovation and creativity required to ensure it could continue to deliver critical content to its students, Chang noted how, “Once again, it came down to creativity as well as an incredible team. We transformed our curriculum in four days to be delivered entirely via video conference. The challenges: make it engaging, make it interactive, give our students the skills they need to have a successful career, and cultivate a feeling of hope.”

The pivot had transformative results; the company has reached a larger audience with the convenience of the video conferencing platform, and those from less privileged backgrounds can participate due to decreased barriers to attend virtually vs. in person. Trainees can also now engage with more instructors from all over the country rather than just those who could come into the classroom.

The company’s rapid adaptation to a major challenge became its new paradigm for more accessible learning. Chang is proud of how that collaborative effort, resulting from creative problem-solving, extended the reach of Clinical Research Fastrack and amplified its ability to transform the research industry.

Roberta Perrella, BS Pharm

Perrella is a pharmacist by education and currently an associate director of clinical operations with a major science company. For her, the pathway to leadership was a process of fully understanding the passions that would drive her career choices. She ultimately decided to attend pharmacy school, and with her dedication to science and advancing drug development, a career in clinical research was the logical next step. By now, she has worked for almost 20 years in the clinical research field, starting as a clinical research associate (CRA) in Brazil, and then working her way up to CRA manager roles, managing teams and having oversight responsibilities over site start-up deliverables in several Latin American countries.

Attributing a portion of her success to “out of the box” career choices, she notes how, “Before joining my current company, I took a quick break from research and accepted a job with a big pharma company. They hired me to lead one of their marketing projects on growth hormone disorders in children. I was interested because not only [did it have] a science component, but it was also an opportunity to expand my knowledge on the pharma sales business.”

Perrella says she received the best career advise ever from her manager at the time. “She advised me that in order to be successful and sustain that level overtime, I should not rush things out. Rather, I should take one steady step at a time, build a solid foundation, and it will do wonders.” She applied this advice to her career and attributes her developmental trajectory to doing so. This is also the philosophy she conveys to whatever team she is managing.

Her ability to embrace new opportunities led her to relocate to the U.S. to work as a CRA manager in study start-up, and it’s a decision for which she says she has no regrets, noting that she has enjoyed assimilating a new culture—both personally and professionally. The foundation for a successful clinical research career journey, according to Perrella, is “getting involved with and embracing organization changes and opportunities to collaborate cross-functionally across the globe.” She describes being inspired by the leaders, direct reports, and colleagues who crossed her path; those experiences motivate her to continue to do her best every day.

Susan, the Site Owner

Susan was a site owner with whom I worked on a diabetes trial. She was the director of three research sites with a fourth one opening in the next quarter. We first met at a site evaluation visit, where I soon learned her remarkable clinical research success story. She had worked in clinical research for 15 years, starting as a study coordinator at a dedicated research site.

After several years in her first job, Susan became frustrated with her inability to affect change and correct deficiencies in the trial and personnel management process. She had an epiphany; the only way she could fully implement and control a successful trial enterprise was to open a clinical research site. She partnered with several former investigators, acquired the necessary funding, erected a solid site infrastructure with policy and process based on her and the investigators expensive experience, and opened a dedicated clinical research site focused on diabetes study conduct.

Another successful site opening followed, and eventually she was part owner and director of research for three dedicated clinical research sites. She proudly informed me that her daughter had entered the clinical research field after college graduation and was preparing to manage the organization’s fourth clinical research site, set to open in several months. She decided early on that she would blaze her own path, and knock down any barriers blocking her progress, whether financial or situational in nature, or due to ridiculous bias.

Conclusion

Female innovators are the driving force for positive change to the clinical trials landscape, and we continually benefit from their creative vision for staff empowerment, research integrity, and passion that drives clinical trial improvement.

Elizabeth Weeks-Rowe, LVN, CCRA, (elizabethwrowe@gmail.com) is a former clinical research coordinator who now works in site selection and education in the contract research organization industry. She last wrote for Clinical Researcher in August 2022 (“Site Origins and the Joy of Self-Promotion”).