Clinical Researcher—September 2021 (Volume 35, Issue 7)

PEER REVIEWED

Sucheta Sachdeva; Tyler D. Green; Terry L. Oroszi

 

The COVID-19 pandemic has affected the health and productivity of employees in nearly every industry in the world. If companies were able to stay afloat and survive financial hardship, their leaders often had to make challenging and innovative decisions. Some companies required essential workers to report to work, while others had to furlough or lay off employees. Many companies turned to options for having some or all of their traditionally in-office employees transition to working remotely to remain functional.{1}

Although not uncommon before the pandemic, remote work gained tremendous popularity as a workaround option for many companies that could no longer safely allow employees to work in an office per local regulations. Remote working became a “new normal” practice almost overnight.{1,2}

Despite the recent increased prevalence of remote work, the clinical research industry is no stranger to the concept.{3} Larger companies tend to provide the option of remote work to a number of their employees. There are many positions associated with clinical research that can be completed in a remote fashion.  Examples of these positions include, but are not limited to, project managers, data managers, safety managers, line managers, clinical research associates (CRAs), clinical trial assistants, and other similar positions.

Although this review could be applied to a variety of clinical research positions, the primary purpose of this paper is to focus on the health and productivity effects of remote work on CRAs, also known as monitors. A CRA “supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor.”{4}

Although many CRAs typically travel frequently in fulfillment of their job duties, there are also remote-working CRAs that are known by a variety of titles depending on the employer, including in-house CRAs (IHCRAs), site management associates (SMAs), site managers, etc.

The 2020 pandemic placed significant traveling restrictions on many CRAs.{5} To maintain oversight for studies, clinical research sponsors decided to push for remote source document verification methods to be implemented where possible.{6} As sites adjusted to new monitoring plans, CRAs found themselves working from home for extended periods and experiencing the benefits and shortcomings of such a lifestyle.

Numerous terms are used to describe remote work, such as work from home (WFH), virtual work, telework, telecommuting, and e-work.{7} Unfortunately, finding an agreed-on definition for each term is still a challenge.{8} For this paper, remote work is defined as work completed with technology outside the office setting, most commonly in the employee’s residence.

General Positive Attributes of Remote Work for Employers

There are several potential cost and productivity advantages to allowing CRAs to work remotely. It can be argued that remote work can save companies on their bottom line,{9} in part because they would not need to lease office space and maintain it for employees.{10} The idea of cost-savings can be further applied to employers of CRAs. Although the employer may cover the cost of internet and home office equipment (e.g., desk, chair, printer, supplies), for remote CRAs, employees are typically expected to cover most, if not, all utilities.

Travel savings are yet another benefit to remote work that would be especially applicable to the CRA position. In the case of traveling CRAs who transition to a fully remote position, the company would save costs on flights, food, per diems, hotel stays, car rentals, transportation, travel time, and any other travel-related expenses.

Another benefit of remote work would be a decrease in employee absenteeism. Employees are less likely to call off work or be late if they work remotely.{11} There would be no need to commute to work and potentially be caught in traffic. Employees would likely work remotely despite minor illnesses or childcare trouble, as they could potentially adjust their environment and workday to accommodate such challenges.{7} IHCRAs/SMAs could take advantage of this flexibility to work later in the day to make up for any time lost during typical business hours. In the end, less company time would be lost, and more work could potentially be completed for the employer.

Increasing productivity by completing a greater amount of work, in general, is another positive attribute of remote work. Remote employees tend to work with fewer distractions than would be found in the office. Productivity findings could also be applied to clinical research. Typical CRA positions require travel during most weekdays. These former traveling CRAs would replace trip time with more frequent general communication with sites and possibly more frequent official remote monitoring visits, thus transitioning more into the IHCRA/SMA role.

More communication with sites could result in issues being resolved quickly, fewer study issues arising in general, protocol deviations being minimized, safety concerns being reported in a timely fashion, and/or growth of confidence between site staff and CRAs in their work on studies.

In 2013, the U.S. Food and Drug Administration (FDA) released guidance on the subject of centralized (remote) monitoring that encouraged it to be used more frequently than onsite monitoring. Centralized monitoring was especially suggested to reduce costs of clinical trials, improve data quality, identify data trends, and increase efficiency.{12}

The confidence in remote work for CRAs has gained momentum as a forefront option to continue clinical trials during the COVID-19 pandemic. The FDA released further guidance during this pandemic, recommending that sponsors “evaluate alternative methods” to in-person monitoring and giving phone contacts and virtual visits through remote monitoring as examples.{13}

 

Overview of Benefits and Shortcomings of WFH for CRAs
Pros	Cons
Cost savings for employers and CRAs	Prone to overworking (dependent on individual and employer expectations)
Decrease in employee absenteeism	Health risks from extended sedentary work
Increased productivity	Overwork can lead to burnout
Fewer distractions	Burnout can lead to turnover
Less time spent travelling
More time spent identifying/resolving site issues
Increased efficiency

 

General Negative Attributes of Remote Work for Employers

Some research disputes the findings on the potential benefits of remote work, citing conflicting information and difficulty measuring the amount of work being completed for specific remote versus in-person roles as obstacles to accurate assessment.{14} Employee accountability is a concern for employers, as it can be challenging to verify that a remote employee is at a workstation and working during business hours. However, the concerns for accountability may be a moot point for CRAs; the traveling CRA position already requires a degree of autonomy to complete most assignments remotely, due to travel to sites for monitoring responsibilities.

Similarly, IHCRAs/SMAs are required to complete remote contacts and visits with their sites. Accountability can easily be verified by contacting the site staff with whom the CRAs complete their visits. Additionally, nearly all CRAs must write reports regarding their visits and provide updates about their sites. Being accountable for their work is engrained into CRAs, as many other team members and the sponsor rely on their updates. Thus, the negative stance of remote work held by some employers may not apply to this position.

Still, depending on the CRA’s personality and work/life balance skills, working from home could turn from being a more relaxed option to one where the work appears never to end. If the CRA has difficulty drawing a clear line between work and personal life, he or she may experience more intense stress due to never being “off” work. These individual coping styles were discussed and helped to postulate a person-centered boundary management theory.{15}

CRAs may feel pressured to work beyond typical business hours to feel “justified” for not traveling. They may think that it is important to be available to site staff and clients at all times, since they appear to be more accessible due to being off the road.

The full responsibility for overwork cannot fall squarely on the employee. Recent meta-analyses for physician and other healthcare employee burnout suggests that organizational interventions would have more effect on the well-being of said employees than ones directed by the employees individually.{16} A prudent clinical research employer would state they support their employees’ health and well-being and provide the necessary tools, incentives, and opportunities for remote employees to live healthier lives.

The risks of prolonged sitting can especially be applied to remote CRAs who need to complete source document verification (SDV) with sites during remote monitoring visits that can last many hours. If employers implement changes to decrease sedentary work time for CRAs, it would demonstrate the idea that clinical research employers complete clinical trials and embrace research results to ensure that not just patients of clinical trials, but also their employees, are living healthier lives.

Productivity and Efficiency Tools

Several communication and exercise tools can help remote employees stay healthy and still productively complete their jobs. Many full-time remote employees receive their home office furniture and supplies from the employer. Employers can incentivize a healthy lifestyle for employees by to providing convertible sitting-standing or, preferably, treadmill desks, so employees are encouraged to stand and/or walk while working. Studies have shown potential benefits from combining standing desks with taking active breaks involving movement as the best option for a healthier and less sedentary work lifestyle.{17,18}

For those who make numerous calls, such as IHCRAs, employers can provide high-quality wireless headsets that allow the employee to stand and walk hands-free during meetings and calls. Mild exercise, such as walking, could improve the IHCRA’s mood and allow for a refreshing change of pace from sitting through calls. Employers could also proactively provide employees with options for ergonomic computer hardware (mouse, keyboard, etc.) to allow for a more comfortable experience while sitting and typing for long hours. A comfortable and supportive chair could also prevent body aches and sores for employees when forced to sit for many hours due to heavy workload assignments.

These are just a few examples to potentially demonstrate to employees that their employer cares about their well-being and is well aware of the benefits of using such tools to better their health.

Fatigue, Burnout, and Employee Turnover

A study by Helfrich, et al. conducted with primary care providers, nurse care managers, licensed practical nurses, and administrative clerks found that understaffing, turnover, and patient panel overcapacity all largely contributed to burnout within the team, regardless of a specific occupation. The study observed burnout as 30.1% lower for fully staffed teams with no turnover and within the capacity panel of patients.{19} Since these results were the same regardless of profession, they could be applied to the CRA.

Remote employees may feel unheard and exhausted if overworked, which can lead to higher turnover. Burnout can be significantly amplified if the employer does not actively encourage work/life balance, adding to the employee’s stress of always being “on the clock.” Many organizations impede their employees’ time by expecting them to remain in touch with work using remote-based technology, like smartphones, outside business hours.{7}

Moreover, finding replacement employees can take much time, which leads to overburdening of current employees. Overwork due to turnover may especially be evident in the contract research organization setting, where revenue usually depends on new study awards, billable hours worked, and the number of completed monitoring visits.

If CRAs are already working remotely, employers often encourage them to work longer hours and take on more work, especially if their coworkers leave the company. Since the process of finding and replacing employees is costly and time-consuming, delays may lead to never replacing empty positions on certain studies, eventually making it the norm for the covering CRA to become overworked. The vicious cycle may continue to take its toll, leading to CRAs exhibiting symptoms of burnout and further increasing the chances for turnover. One option to break the cycle is to have the employer change tactics for hiring qualified replacements quickly.

Employee Retention

Although the bottom line is important, there is a shared responsibility for companies and employees to implement working limits in consideration of the well-being of employees. The employer should try to be respectful of the employee’s time by assigning appropriate workload and ceasing the push for work to be completed outside business hours.

Along with the employer, employees can be trained to manage their time and tasks better so that working past business hours is rarely necessary. Remote employees would also need to work on individual traits to learn to separate work time from off time at home.

One suggestion for remote CRAs is to not forward their work e-mails to their personal phones and to turn off their computers at the end of the business day, effectively “cutting the leash” to the habit of checking work e-mails or walking back to the home office computer to address issues that could wait until the next business day. Having this discipline would be dependent on the individual’s dedication to maintaining a pleasant work/life balance.

Conclusion

Although accountability and oversight may initially be a concern, by hiring remote CRAs, employers would enjoy cost savings, fewer employee absentee days, and increases in productivity, among other benefits listed in the table earlier in this article. The CRA, meanwhile, may have several advantages in working remotely, including feeling less distracted, having less stress due to no travelling, increased job satisfaction, and a more manageable work/life balance. Conversely, if overworked, the remote CRA position would adversely affect mental health, especially if the CRA cannot draw clear boundaries between work and home life.

Overall, both the employer and remote employee are responsible for the success of the business and the health of the remote employee. Although this paper attempts to apply known research regarding remote work to the CRA position, more research needs to be collected and documented, focusing on feedback and data collection regarding remote work from traveling CRAs and remote CRAs directly.

The clinical research industry has had remote working positions for years. Still, it will be interesting to see if employers will have the prescience to amplify the benefits and tackle the challenges involved with the remote CRA position and simultaneously retain employees for the long term.

References

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Sucheta Sachdeva (ssachde@rockets.utoledo.edu) is a Pharmacology and Toxicology graduate student in the Boonshoft School of Medicine at Wright State University in Dayton, Ohio, and a remote Clinical Research Associate/Site Management Associate with more than 10 years of experience in the clinical research field.

Tyler D. Green, DNP, APRN, PMHNP-BC, is a Clinical Instructor in the College of Nursing & Health teaching at Wright State University and a mental health nurse practitioner for a private practice in Dayton, Ohio.

Terry L. Oroszi, MS, EdD, is a specialist in healthcare and homeland security and an Associate Professor and Vice Chair of Pharmacology and Toxicology in the Boonshoft School of Medicine at Wright State University.