Spurred by the shift to decentralization, the clinical trials workforce needs new roles and skill sets to master a rapidly changing environment.

Trial staff must learn to deal with changes in trial technologies and methods, the increased volume and speed at which data must be managed, and the growing complexity of multisite trials and multi-partner platforms.

Some of the responsibilities involved in handling these innovations are so broad that new positions — such as site technology support, remote site coordinators and decentralized investigators — will be needed to make the workload manageable.

New skill sets around how physicians and site staff interact with trial participants will be required to accommodate the technologies of decentralized trials, Kimberly Ray, an industry consultant who led the Association of Clinical Research Professionals (ACRP) Task Force on Decentralized Clinical Trials and Technology Competencies, told CenterWatch Weekly.

Rather than loading additional responsibilities onto the research coordinator, principal investigator or other existing staff, the ACRP task force’s recent report says, responsibilities may need to be spread among a variety of research staff in both current and newly developed roles.

Given the number of different technologies used, such as telemedicine and wearables, and the massive amounts of data that must be managed, IT-related positions will definitely grow in importance, Ray said. Sites will need IT support personnel to troubleshoot glitches or connectivity issues. CRCs can play that role, Ray said, but “this is an immense amount of work and it’s not realistic to expect the CRC to act as a help desk or to have expertise in every type of technology or platform used.”

And while many sites don’t budget for their own technology applications, some are choosing to purchase platforms that work best for their organizations, rather than continually trying to accommodate the various technologies provided by each sponsor or CRO for different trials. According to ACRP, this could lead to demand for a variety of new positions, such as:

• Application specialists that provide training and support for site-based technology;
• Business intelligence analysts to assess near- and long-term strategic technology needs;
• Study management system managers; and
• Outside technology consultants to evaluate a site’s technology for efficiency and security.

Principal investigators (PI) in decentralized or hybrid studies will need training and support to be proficient in the use of telemedicine to diagnose, evaluate and engage with patients, the report adds. The PI must also be competent in any technology or methodology used to monitor patient progress, including wearables, micro-sampling and patient e-diaries, among others.

Ray also pointed to another new role, that of a virtual patient navigator dedicated to guiding patients through trial procedures and technology. These individuals could also be responsible for supporting resolution of queries to patient-generated data. The CRC may play this role for hybrid or less complex studies, but fully decentralized trials and very complex hybrid studies may require that new dedicated role.

The ACRP report says another evolving role is that of the patient call center or patient recruiter. Tasks associated with recruiting trial participants from broader geographic areas for decentralized and hybrid trials will expand, for instance, and recruiter workflows must be adjusted to accommodate increased screening and recruitment volume. Virtual patient support could also become an added responsibility.

One current job likely to decrease in importance in a decentralized trial ecosystem is the site data entry coordinator, ACRP predicts. For the near term, many trials will still require some transcribed data entry into EDC systems. However, as more data come in as direct source, that need will fall, so staff in this position may elect to develop data management skills, which will remain important in a decentralized or hybrid research environment.

ACRP also notes that there could be roles for physicians local to patients to perform some hands-on procedures under the PI’s direction, possibly while on a telemedicine call. These doctors could supplement the role played by home health nurses; their participation would depend, case by case, on their clinical research training and compensation needs.

“If ever an industry was in need of change, it’s ours,” said Paul Evans, president and CEO of Velocity Clinical Research. “We live in a period where there’s a very rapidly changing environment — probably faster than any of us have ever experienced in this industry.”