Due to the vast influx of technology and the advent of Risk-Based Monitoring, the clinical research landscape is now evolving fast, and along with it, so are jobs in the field.
Denise Snyder, associate dean for clinical research at the Duke Office of Clinical Research (DOCR), says highly specialized skills sets among coordinators is the wave of the future in employment in clinical trials.
“The old model was one coordinator working for one investigator, and the coordinator handled all tasks across many projects. The new model is high-performance teams of coordinators helping, contributing and bringing exactly what they are good at to the table,” said Snyder. “That’s the direction we’re moving in.”
Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP) explained that as risk-based monitoring has taken hold and more monitors are analyzing data from a central location rather than traveling to the sites, sponsors and CROs are looking for clinical research coordinators with more of a strong math background. And as the sponsors’ and CROs’ relationships with sites becomes ever more important, sponsors and CROs are looking for clinical research associates who excel at fostering friendly, supportive connections with sites.
“I think we’re going to see a morphing of these role into subspecialties — a data analyst and site-relationship manager type of CRA, along with the traditional role that the CRA has always had,” said Kremidas. “With CRCs, I think we’ll begin to see a quality assurance focus, someone who oversees the input of the data into the eCRFs. I think we’ll see a technology type of specialist for patients to call in order to get help logging on.”
Beth Harper, workforce innovation officer for ACRP, said technology is behind the lion’s share of these changes across the industry.
“We now have tools and technology that can aggregate the data, and allow us to look for and spot trends across massive amounts of data,” Harper said. “We never had that before, and it has changed everything.”
As a result of this evolution of the CRC and CRA roles, ACRP has created a “certified professional” certification onto which subspecialty designations can be layered as needed. Last month, ACRP launched the subspecialty of project management. The group is also exploring subspecialties in data analysis, statistical analysis, and relationship management.
“As roles continue to evolve, we will create new certification programs,” promised Kremidas.
Sean Walsh, site veteran and now director of site development for ClinEdge, said he thinks that as virtual trials become more popular, the industry will need more home health nurses to visit patients where they are.
One thing the field won’t be needing more of is people that focus on regulatory. That’s because eRegulatory is coming on strong in the field now, and work that used to require a team of people working for weeks on a thick binder of papers now can be handled with a few computer clicks, said Walsh. It’s just a matter of adoption.
“That job is phasing out,” Walsh said. “A few years from now, that’s just going to be a 10-minute job for a coordinator.”
Academic medical centers are beginning to restructure themselves around the coming changes in the workforce around clinical trials.
Explained Bree Burks, senior director of Vanderbilt Coordinating Center in the Vanderbilt Institute for Clinical and Translational Research, 18 months ago, the university established the coordinating center to better organize their talent working in the clinical trials space. Now investigators at Vanderbilt can tap into the center for assistance with various parts of their clinical trial — or all of it.
Said Burks, with this new model, PIs can pull only what they need from the pool of coordinators, and the coordinators have a chance to stick with the areas where they excel — as opposed to the old model where a PI had one or two coordinators who wore all hats, from study start up duties, to recruitment, to budgeting, to regulatory to patient visits.
Within an environment like this, said Burks, coordinators can put their careers on hyperdrive, which was not possible using the old model. And new jobs have been created within this environment, such as the clinical trials navigator, a person who handles high-level logistics around trials.
Vanderbilt has also added auditing and IT tracks, and is soon to add an informatics track.
The Duke Office of Clinical Research is working on a similar concept among its clinical research workforce, which includes “swat team coordinators” who can be sent in during an emergency, said Snyder.
“The landscape is changing,” she said. “Certainly we need a different type of coordinator today than we needed 20 years ago. We are seeing more defined roles.”
