Large life science companies have fired untold tens of thousands of employees during every year of the ongoing downturn—a period of both financial chaos and pharmaceutical mega-mergers. Here's one estimate, and another. Yesterday, having digested Schering Plough, Merck announced it would terminate 15,000 people and close eight research locations.

Which doesn't mean the research industry is devoid of job opportunities. Kforce is an example. With a Tampa, Florida, headquarters and 2,000 workers in more than 60 locations in the U.S. and Philippines, the publicly traded Kforce has approximately $1 billion in annual revenues. It serves four main sectors: finance and accounting; government; technology; and life sciences.

The trial-related aspects of the Kforce operation are as sophisticated and mature as anything from smaller companies specializing in clinical research. Not long ago, the company's Jennifer Worrell won the honor of "CRA Of The Year" in a contest judged by industry and coordinated by Pharma Times. And Kforce received this award for excellence in a strategic supplier from Pfizer based on handling 200 trials during 2008. What Kforce is doing can scale.

ClinPage recently checked in with Peg Connelly, Kforce's VP of clinical operations. She's a nurse by training and has spent 17 years in the industry at such firms as Bristol Myers, Serono and Pfizer. "I've done every job that people in my organization are doing now," she says. "I know what it's like sitting over at the pharmaceutical company—small, medium and large."

Comprehensive Staffing

Kforce supplies workers for most of the major elements of a modern clinical trial. To name a few areas, the company places its experts in medical writing, regulatory affairs, quality assurance, clinical operations, pharmacovigilance, good clinical practices (GCP) inspection readiness and trial master files (TMF).

"There is more and more focus on documentation," Connelly says. "TMF teams are definitely something our sponsors have been interested in. And [patient] recruitment specialists. We have many requests around recruitment."

Another significant chunk of work is supplying the clinical research associates (CRA) who monitor investigative sites. Connelly says the firm's well-trained emissaries often fit in so smoothly at their place of work that they almost blend in as full-fledged employees.

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Peg Connelly of Kforce

In a climate of economic uncertainty, she's proud that Kforce's retention rate is actually rising. That's no accident but, rather, a result of a serious effort to show clinical trial professionals that they can have a satisfying career at Kforce. The company seems to understand that sponsors like continuity and that some monitors themselves feel roughly handled by other employers. "We have a multifaceted retention strategy," Connelly says, citing the use of mentors and training. "We're proud of our metrics in this area."

Supportive Environment

The firm's culture also helps. Monitors can expect to be on the road 35 percent of the time. Connelly says Kforce doesn't try to camouflage or sugarcoat the burden of that travel. The firm also pays attention to what therapeutic area the individual prefers to work on. "It's critical the CRA is working in an area they really want to work in," she notes.

In its miniature democracy, the company allows workers to designate a few representatives who can speak directly to senior management. And whenever anyone raises their hand, there is a no-blame policy. The emphasis is on resolving issues, not assigning fault. Says Connelly: "It is better to have an early hand raised than have a problem later on. You listen to people. We're hearing what it feels like out there."

Internally, Kforce tries to make sure that the technology that monitors need, whether laptops or printers, is working flawlessly. That's not always easy in an IT world dominated by generic business software that might not have been designed to be used outside company firewalls or inside airports and hotels.

Kforce is particularly insistent on giving its clinical trial folks manageable but not excessive workloads. Connelly cites that as the most important factor in ensuring good workers stay at any company. Kforce takes care to determine what the optimal work load should be. In that effort, it uses some of the Six Sigma methodology to calibrate assignments across therapeutic areas with varying levels of complexity. Kforce also relies on internal knowledge that in some cases is highly localized to a particular site, investigator or sponsor firm.

Shared Metrics

Relentless process re-evaluation, Connelly says, has helped Kforce shave its cycle times by more than 50 percent. The firm's operational philosophy is metrics-driven, she says. "We've been asked to share our metrics globally with some of our larger clients," she observes. "They've been adapted by other vendors. We're very proud of them." Discussing metrics with clients, she says, helps them understand how Kforce sees their project: "They create a conversation."

Technology is helping redefine what monitors do, morphing their roles by utilizing electronic data capture (EDC) to assess when to visit sites. "EDC provides real-time access to data," says Connelly. "It has, in a way, revolutionized what we're doing. A monitor's job has been continually added to over the years. It's more of an overall site management, project management role."

Connelly declined to quantify the economic benefits of EDC, but doesn't appear to doubt that they exist. "It has made the site management role much more efficient for the sponsors. I think we have affected the overall budgets for monitoring. It's more proactive. It's more calculated. There are financial benefits."

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