Guest Column | August 30, 2023

When Workers Are Down, Clinical Leaders Must Rise Up

By Oscar Segurado, MD, Ph.D., chief medical officer, ASC Therapeutics

Throughout the pandemic, many people abandoned the healthcare field, and yet the need for healthcare workers and clinical study staff continues to increase. According to the U.S. Bureau of Labor Statistics Job Openings and Labor Turnover Summary, the number of quits by healthcare and social assistance workers increased by approximately 69,000 from April to May 2023. At the same time, the number of active clinical trials are growing. CROs are struggling to identify qualified professionals to take on site start-up, clinical operations management, and data management roles. And, it has been exceptionally difficult to fill CRA positions with experienced workers. In fact, CRA positions have seen shortages since at least 2015, according to the Association of Clinical Research Professionals. Furthermore, the Society for Clinical Research Sites reported that the largest group of CRAs leaving the workforce in 2022 were those with 10+ years of experience, a rate 55% higher than in 2021.

Solutions For Attracting And Retaining Clinical Study Staff

Investing in people and redesigning aspects of the work environment can help address staffing shortages. Taking on less experienced staff, even interns fresh out of college, may justify the training effort required if your organization has a structured career ladder. Although training and coaching take a significant investment in time and resources, this approach can prove successful for companies with flexibility for roles across clinical programs. Working with relevant college majors and medical schools may be a helpful strategy in finding and attracting these promising professionals.

Attracting quality candidates also involves offering competitive salaries and flexible work options. Salaries should be aligned with fair market value (inclusive of base pay and bonus structure), especially with high-level positions. To do this, you can review industry-specific salary surveys, check government sources, or consult with recruiters and HR professionals. Another retention strategy is to implement flexible work schedules and programs. After the pandemic, ASC Therapeutics continued its adoption of hybrid work, with a balance of work done remotely and in the office. In general, hybrid work has become a high priority for the workforce when considering the pros and cons of staying with an employer or starting a new position.

Tailoring retention strategies to the individual person should also incorporate established premises for diversity, inclusion, and equity. In other words, all workers should be valued and feel integrated in the clinical team, independent of personal, social characteristics, or beliefs. To do this, you might consider consulting professional experts in diversity, inclusion, and accessibility. Take employee requests, suggestions, and complaints seriously. Get to know your employees and their needs. Being aware of and accommodating to various religious holidays and practices will let your leaders and employees know you care about their lives outside of work. A specific accommodation might include creating a small private space for those that need to use a breast pump or for those that need to pray during the day to follow their religion. Of course, other improvements can come about when you inquire about their needs and ask for suggestions on how to improve their workdays.

Professional Development, Automated Solutions To Mitigate Burnout

Poor company culture and inconsistent or inadequate company policies are substantial contributors to burnout, job dissatisfaction, and workplace shortages. When shortages occur, utilizing existing workers to fill the gaps can be detrimental to the workplace culture and eventually lead to an even greater shortage. Clinical study sites have been taking on larger numbers of trials and that decision stretches their true capabilities, leading to slowing enrollment rates and increased risk for errors and harm to study participants. This trend leads to increased pressure and even burnout of clinical team members. Therefore, staff well-being should be addressed through specialized advisors and methodologies focused on physical and mental interventions, potentially leading to workplace model redesigns. Some options include bringing in a consultant to identify methods of mitigating burnout that would be effective for your specific workplace or seminar offerings that teach mindfulness or other mental health exercises. A company might also implement a policy in which it agrees to no contact outside of work hours, as much as possible, and designated break times. More collaboration by team members may be considered where possible, so that workloads can be dispersed more evenly. Or help can be implemented in a give-and-take manner when different roles are facing pressures at differing times throughout the day, month, or year.

Remote work and telehealth are currently the primary solution for healthcare shortages. Reducing the number of in-person visits in clinical trials by switching to virtual visits can not only increase patient enrollment and retention but also reduce the burden on workers. Virtual visits and remote work provide workers with more flexibility to conduct their work in the office or from home.

At ASC Therapeutics, to ensure every team member keeps everyone else involved and motivated, we conduct weekly meetings and generate progress reports that encourage accountability, trust, and transparency. Our head of clinical operations leads these meetings, including both in-person and remote participants, and generates weekly reports. The chief medical officer provides high-level guidance for these efforts and ensures coordination with other functions. Furthermore, we have implemented a hybrid model to ensure that our team members can seamlessly work remotely and in the office.

Other developments are related to automating workflows, making workdays easier and more patient-focused. This may be done by creating quickly fillable spreadsheets and forms, using project management software, and requiring documentation that may involve a bit of extra work on the front-end but will allow more seamless workflow at later stages. Introducing an optimal work-life balance while keeping a close eye on KPIs within the monitoring team will contribute to improved communication and motivation at the clinical site. This approach can drive increased patient outreach and higher-quality clinical programs.

Improving work-life balance may also involve having a specific work communication device and computer. Using personal devices blurs the line between work and home, and it places pressure on people to continue to work at home. Offering a separate phone or laptop that stays at the workplace or is only used for work can help create more separation. Implementing and assessing KPIs can also show both the worker and their supervisor that the necessary work is being completed, that extra work is not necessary, or where work may need to be redistributed to others or handled differently to complete in a timely fashion.

About The Author:

Oscar Segurado, MD, Ph.D., is an executive veteran with extensive global leadership experience in translational science, clinical development, and global regulatory and medical affairs. He is the chief medical officer for ASC Therapeutics, a fast-growing biotechnology company focused on developing curative gene- and cell-based therapies for rare blood disorders. Segurado is the author and co-author of over 100 peer-reviewed publications, including Nature and Lancet, books, and medical articles, as well as a member of several scientific and medical societies, including his role as a Forbes Council Board Member. He also holds a tenured Professorship of Immunology at the University of Leon, Spain. He received his Ph.D. from the University of Wuerzburg, Germany, and MD from the University of Salamanca, Spain.