Improving compliance consistency via training

Specialized CR positions, budget templates

Clinical research (CR) organizations should focus on two key areas when targeting compliance: First7, they should centralize their clinical trial operations or make the decentralized system more consistent; secondly, they should put more resources into CR education and training, experts say.

Here are some ways research sites can improve their consistency, compliance, and staff training:

• Put adequate resources into staff education.

"Because of the economy, people don't have funding, so research employees sometimes are put into these jobs without enough training," says Kelly Willenberg, BSN, MBA, president of Synergism, LLC of Chesnee, SC. Synergism provides research compliance, including billing and program compliance services for clinical research sites.

"Study coordinator jobs are extremely demanding, and there are a lot of regulations and things you need to know to do it well and to be accountable," she adds. "Training and education are key, and so many sites do not offer enough training, and I think research is going to suffer for it in the long run."

Online CR courses are fine, but these shouldn't be a one-time educational effort.

CT coordinators need continuing education and mentoring. Their education should focus on all aspects of clinical trials and not focus solely on human subjects research protection, Willenberg says.

"The better the education and training, the better the culture of compliance an institution has," she adds. "When everyone is well-trained the process will flow better, and there's no denying that."

Research sites could hold monthly training and continuing education sessions for coordinators, says Tammy Anderson, CCRC, CCRA, CRCP, director of the clinical trials office at the office of the vice president for health sciences, Virginia Commonwealth University in Richmond, VA.

"We have coordinator training on the last Friday of each month," she says. "We provide a monthly topic discussion about the conduct of clinical trials."

Virginia Commonwealth University also provides an Association of Clinical Research Professionals (ACRP) training course with detailed and complex training for advanced coordinators. This course assists them with taking their certification exam, Anderson says.

"We also provide individual training, as needed in the different departments," she adds. "We have a checklist of competencies and training we require of all staff when they're hired, including human subjects protection, good clinical practice guidelines, and HIPAA training."

• Create a career ladder that encourages experienced staff to stay.

One problem research sites encounter involves high staff turnover. Better education and training can help reduce turnover, but so can dividing professional roles in a way that reduces employee frustration and increases opportunities for career advancement.

Virginia Commonwealth University's new centralized CR office has created a model for this type of study coordinator career ladder by dividing jobs into specialty positions of recruitment specialist, regulatory specialist, study coordinator, and others.

For instance, the regulatory specialist position is a good beginning job for new study coordinators. They can start with this job, gain experience and learn more about how clinical trials work.

"We train our regulatory specialists to be back-up to the coordinators and assist with visits," Anderson says. "They can move up the career ladder to assistant coordinator and then, after two years of experience they can sit for a certification exam and become certified."

Regulatory specialists make certain all paperwork is available during coordinators' visits. They process lab work, enter data into electronic databases, copy source documentation, and set up patient binders.

A next level up are the entry level coordinators who can perform patient screening and patient visits, but are generally assigned to less complicated protocols under the supervision of an advanced coordinator, Anderson explains.

Advanced certified coordinators work directly with the departments involved in a study to coordinate multiple departmental issues and needs, including scheduling and developing more complex study protocols or inpatient studies. All of these roles can be held by non-RN research staff, depending on their level of experience, training, and education.

A parallel career track includes an entry level RN coordinator and an advanced certified RN coordinator.

Recruitment coordinators are certified coordinators because this role requires a professional who fully understands study exclusion and inclusion criteria and how to conduct clinical trials, she notes.

"The recruitment coordinator position is equivalent to an advanced coordinator," she adds.

Research assistants are at the very bottom of the career ladder in the centralized office, and this role typically is held by volunteers or students, Anderson notes.

"These are the ones who take paperwork around to get signatures; they make copies, run the mail, and perform basic office duties," Anderson says. "We take advantage of federal work study programs at the university so that financial aid programs pay most of their salaries."