Kenneth A. Getz
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Based on recent interactions with pharmaceutical, biotechnology, and CRO companies, it appears that the role of the clinical
research associate (CRA) is undergoing intense examination and revision, driven largely by the adoption of e-clinical technologies
and new study conduct practices. Several companies have noted the transition of their CRAs into data managers with an increasing
amount of their administrative activities handled by electronic technology solutions. But mounting study conduct performance
pressures during the past five to seven years are also pushing CRAs to redefine their roles all together: from monitor and
taskmaster to trainer, helpdesk, and active site collaborator and motivator. Communication, e-technology savvy, and interpersonal
skills have never been more critical to CRA effectiveness.
Changing job demands
Companies' expectations of CRAs have changed in several tangible ways. Standard operating procedures (SOPs) today, for example,
tend to give CRAs less time to visit and to follow up with investigative sites. SOPs also require more detailed documentation
of monitoring activities, including more elaborate enumeration of items contained in study binders.
The New ABCs for CRAs
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"CRAs across the board have been working longer hours than they did before 9/11, largely as a result of increased airport
security," added Lorry Witte, RN, BA, CCRA, CCRC, a Twin Cities, MN-based study monitor. "Yet the pressure to beat deadlines
is as tight as it has ever been, requiring CRAs to spend more time working on laptops in airplanes and in hotels and airports."
Heavy travel burdens, rising airline-related costs, and delays have prompted many companies to decentralize CRA functions,
including creating regional CRA positions and limiting travel within specific territories. "Regional CRAs, on average, spend
60% to 80% of their time traveling. But many now stay in the same time zone, so there are less connection issues and it's
quicker and easier to get where they need to go," explained Sandra O'Donnell, MA, MT (ASCP), CCRA, senior regional CRA for
ZARS Pharma.
New regional positions can significantly reduce overhead costs. According to CRA managers in several major pharmaceutical
companies, a large percentage of regional CRAs operate out of home offices. Doing so means, however, that CRAs need to be
even more computer-savvy than their office-based counterparts because the bulk of communications and training happens electronically.
It also means telephone and e-mail messages have to be more skillfully composed and delivered to prevent miscommunication.
On the regulatory front, CRAs need to be prepared for more comprehensive tracking of protocol deviations and adverse events
observed in new source documentation formats. "Clinical trial teams must decide upfront and agree with health authorities
on what constitutes source documentation on studies involving remote data transfer, machines with memory, and patient reported
outcomes," said Giovanni Della Cioppa, head of methodology and innovation in development at Novartis. "It's not always clear.
But if it is not obvious and if the clinical teams don't spell it out, CRAs will each have their own view or they may not
be prepared to track and report properly," he said.
eCT gurus
Without a doubt, CRAs today need to be a lot savvier about information technology than most veteran study monitors ever anticipated.
They also need to embrace more regular and formal means of communicating with study coordinators and investigators rather
than through sticky notes and memos. "It has been a tough—and dramatic—transition for many paper loving CRAs," said Laurie
A. Halloran, BSN, MS, CCRA, a Boston-based clinical trial consultant. "I have seen monitors who could only monitor if they
printed out the entire electronic case report form [eCRF] on paper. But those days are pretty much gone at this point."
"Most CRAs, once they've done one trial using electronic data capture (EDC) never want to go back to paper. But study coordinators
can be fiercely resistant, especially clinic nurses who aren't dedicated to research," said Minnesota-based CRA Witte. "To
overcome the inertia, CRAs need to be contagiously enthusiastic about EDC. They also need to be proficient at using a variety
of technology solutions if they are to champion speed-enhancing technology and troubleshoot with study coordinators," she
said.
