The role of a Clinical Research Associate (CRA) changed dramatically during the pandemic. 76% of CRAs did most of their monitoring visits remotely in 2020, up from just 18% in 2019. And technology advances haven’t slowed down since. In 2021, 97% of sponsors were using software to review source data remotely.
Clinical Research Associates remain vitally important. But the days when they spent most of their time flying between research sites so they could sit in rooms and flip through binders are over. With the rise of remote monitoring, CRAs need to focus on learning about technology, analyzing large amounts of data, and communicating with sites, not on managing paperwork or planning in-person visits.
After speaking to Beth Harper, ACRP Workforce Innovation Officer, and former CRAs on our team, we’ve gathered a list of talents Clinical Research Associates should develop to prepare for the future.
With technology, critical thinking, communication, and digital research skills, CRAs and future CRAs can avoid being left behind by a constantly changing industry.
CRAs need to increase their comfort with technology.
Although 97% of sponsors and CROs use monitoring technology, not all Clinical Research Associates are comfortable working with the software.
As Beth Harper put it on The Next Phase podcast, “We can have all this great technology, we can have refined our processes and streamlined things—but at the end of the day, if we don’t have a skilled, empowered, and competent workforce to use all this technology efficiently, we’re just going to be stuck with these chronic delays.”
Technology fails to increase productivity when software is difficult to use, CRAs haven’t received proper training, or organizations have too many different systems.
In an ACRP survey, one-third of Clinical Research Associates said the technology they use isn’t intuitive and two-thirds said that technology didn’t reduce duplicate data entry. Only one-third felt they had enough training to efficiently do their jobs. But these problems can be solved with the right software and the right training process.
1. Sponsors and CROs must choose integrated, intuitive technology.
With dozens of clinical trial solutions on the market, sponsors and CROs shouldn’t settle for software that’s difficult to use or that doesn’t integrate well with other systems. When Clinical Research Associates waste hours logging into different systems and entering data multiple times, clinical trials experience unnecessary delays.
To ensure they’re choosing the right software, decision-makers should consult with their CRAs and with their research sites during the buying process to make sure all clinical research professionals can use the software easily.
CROs and sponsors should also choose software that has an open API and that can integrate with other systems. It’s not realistic to expect one vendor to create best-in-class ePRO, eCOA, EMR, eISF, eTMF, eConsent, CTMS, and eSource software.
But it’s also not realistic to expect a Clinical Research Associate to learn a dozen unintegrated systems just to do their job. If sponsors choose software programs with an open API, CRAs can use that program as a central hub that stores data from different systems in one location.
In fact, using a central hub to gather data from multiple systems let one Florence customer decrease their study start-up time by 49.2%.
2. CRAs should embrace independent technology training as well as company training.
Historically, lack of professional development has been one of the major causes of CRA turnover. This is worrying, because the clinical research industry has a 24-29% turnover rate, compared to an average turnover rate of 15% across the U.S.
If CRAs don’t know how to grow their careers or are intimidated by new technology, they may leave the profession to seek other opportunities. While 80% of CRAs said they’d received training relevant to their jobs, less than 50% thought their organization offered training that set them up for success.
For Clinical Research Associates to feel like they’re growing in their career, they need professional development that goes beyond the basic requirements of their job. Rajneesh Patil of IQVIA suggests that CRAs need to become comfortable with “emerging technologies, mobility applications, novel monitoring platforms, and analytics tools.”
This technology training can come from industry events, like those hosted by ACRP and SOCRA, or from online digital research courses. General training can give clinical research professionals an in-depth understanding of topics that apply to every kind of clinical trial software.
With a strong understanding of change management, data privacy, and SOPs, CRAs can confidently embrace any technology their sponsor or CRO throws at them.
CRAs will focus on critical thinking and data analysis instead of paperwork.
20% of clinical research professionals struggle with burnout because of their workload. Clinical Research Associates in particular struggle with long days, with several former CRAs at Florence describing work days that lasted from 4 or 5 a.m. until 8 p.m.
Clinical Research Associates can’t sacrifice any tasks that ensure participant safety or data quality. But they could cut out much of the time they spend traveling or conducting basic document and data reviews.
One worrying statistic: Clinical Research Associates used to spend 18% of their workweek, or nearly an entire day, sitting in cars or on planes. With the growth of remote technology, onsite visits can now occur only for essential processes like site initiation or quality audits.
Technology can also help CRAs conduct document reviews more efficiently. In the past, Clinical Research Associates only saw documents and data when they visited the site in person. They might catch data errors weeks after they’d occurred, leading to all of the informed consent or case report forms having the same error. The site would be stuck with a lengthy correction process, or, worse, their data would become unusable.
If CRAs use remote monitoring software to check on sites’ documents and data regularly, they can catch minor errors and notify sites of them as soon as they occur. This prevents further errors and turns data review into a quick, daily process instead of a lengthy one that occurs every few weeks.
1. CRAs can grow their analysis skills with the time they get back from traveling and document review.
IQVIA’s Rajneesh Patil foresees a world where Clinical Research Associates focus on ensuring site quality and performing data analysis rather than simply conducting data and document review.
For example, rather than checking whether consent forms are signed on the correct line (a process that can be automated with eConsent), CRAs can examine how long it took different sites to enroll participants and receive their consent. This lets CRAs use their critical thinking skills to make trials more efficient, rather than spending their time on repetitive tasks.
With eSource, eCOA, and ePRO systems, sponsors will also receive more data than ever before. Clinical Research Associates can focus on analyzing this data to make better decisions about the trials’ efficacy, rather than on making sure the data was recorded correctly.
CRAs will focus on building relationships with site staff.
Technology is great at replacing mundane tasks like fact-checking and data entry. But it can’t replace human interactions.
With technology to help with document creation or data input, Clinical Research Associates can instead focus on “soft skills,” like training site coordinators and staff, helping all team members understand protocols and compliance, and communicating with sponsors.
CRAs can bring emotional intelligence and a human perspective to the clinical research process, ensuring that research sites and participants don’t feel detached from the sponsors and CROs they’re working with.
When they aren’t worried about reviewing hundreds of documents in a single visit, Clinical Research Associates will have more time for these important human interactions—without sacrificing the efficiency or safety of their trials.
The CRA role will continue to evolve.
Clinical Research Associates will always play a vital role in connecting research sites to sponsors and CROs, ensuring trial data is high-quality, and protecting participants. But how they perform those functions is changing.
Rather than spending a full day at the site reviewing old documents and data, the Clinical Research Associate of the future will use technology to monitor sites on an ongoing basis. This will open up more time for CRAs to conduct critical data analysis and form positive relationships with sites and participants.
CRAs who want to prepare for this future can start developing their technology, analysis, and communication skills with our free Digital Research Certification course. Sign up today to learn about compliance regulations, different forms of clinical trial technology, the change management process, and much more.
Adams, B., & Harper, B. (2021, March 4). The Evolving Role of the CRA/CTA. https://open.spotify.com/episode/4UMOFAeFwYsMEvgcNkelMt.
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Roland, T. (2019, May 22). Modern CRA perspective: Use of technology in clinical trials
. SOCRA. Retrieved November 17, 2021, from https://www.socra.org/blog/modern-cra-perspective-on-the-use-of-technology-in-clinical-trials/.
Studna, A. (2021, April 15). Turnover for clinical monitoring remains high
. Applied Clinical Trials Online. Retrieved November 17, 2021, from https://www.appliedclinicaltrialsonline.com/view/turnover-for-clinical-monitoring-remains-high.
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By Florence Healthcare, a leader in clinical trial operations
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