Wanted: Coordinator with good attitude, will train
Keep metrics to evaluate performance
Like other rural areas in the United States, the Rocky Mountain Diabetes and Osteoporosis Center in Idaho Falls, ID, sometimes has trouble finding study coordinators.
"Finding someone who is experienced in research almost never happens," says Delos Jones, RN, MSN, CCRC, research manager for Rocky Mountain Diabetes and Osteoporosis Center.
So it's crucial that the research site have an effective way to train and evaluate clinical trial staff.
Here are some tips on better managing CT staff:
1. Hire people with potential and good attitudes.
"When we have a candidate we're seriously considering hiring, we have several people in on the interviews, including myself and the operations manager," Jones says.
The site sometimes asks job candidates to spend time speaking with study coordinators and staff in the regulatory department.
"This helps them see how personalities fit and how this person fits in," Jones says.
Another good strategy is to hire interns who've already worked at a site for several months.
"Everyone in the office gets to work with interns, and they see them on a good day and on a bad day," Jones explains. "And people get to see how they work with everyone."
2. Provide adequate training.
"We send all our coordinators to Northwestern University in Chicago, IL, for three days of training, so they all get basic training," Jones says. "Then we bring them back and have them work with coordinators and monitors."
Also, CT sites can send at least some staff to conferences, and this also could serve as a motivator.
"One thing we do on an annual basis is we choose a number of coordinators to attend an ACRP convention," Jones says. "It's based on their performance, length of time they're with the company, whether or not they're certified, and when they had last attended a conference."
3. Evaluate staff in all available ways.
Staff evaluations are an effective tool for identifying areas where employees need more training and determining which coordinator is good at specific tasks and which needs mentoring.
"We do general office evaluations, looking at employees' organizational skills, how they treat patients and monitors, and we look at their overall behavior in the office setting," Jones says.
Each year there is a formal evaluation interview, but when problems occur in the interim, a manager will meet with the coordinator and work it out.
The ways clinical trial sites can identify criteria for evaluating staff is through published research, the use of evaluation tools, and talking to monitors to see what makes a good coordinator in their eyes, Jones says.
"We've developed a tool that looks at clinical trial coordinators' professional development and also at their skills as a coordinator," Jones says.
These skills include drug accountability, query resolution, case report form entry time, and retention of patients.
"The biggest thing we've learned is you really have to catch problems in their early stages," Jones says. "If you wait until the annual review to deal with issues it's generally too late, and they're too far behind or too entrenched in what they're doing — so the evaluation has to be an ongoing daily activity."
4. Work with monitors to collect evaluation data.
Study monitors collect query resolution data, and they can share it with a site.
"They can tell you the number of queries the coordinators have and how long it takes to resolve a query," Jones says. "So they can give you a lot of good information about how well the coordinator is doing."
Monitors also can provide information on drug accountability. They look at drug logs and binders and make sure coordinators have logged drug shipments into the drug binder as an expense immediately after they arrive, Jones says.
Clinical trial sites have their own patient retention data, and it is simple to see how many patients who entered a trial did not finish for each study coordinator.
"We want to know what their reasons are for not finishing, whether they had an adverse event or whether they didn't feel they were being taken care of," Jones says. "Maybe the person lost interest in the study, and this is something the coordinator could do something about."
Coordinators who have a poor track record in patient retention generally will have a meeting with their supervisor to address the problem, Jones adds.
Monitors keep data on case report form entry time, and it's relatively easy for them to retrieve the information since it's mostly in an electronic format.
"Sponsors generally have a metric they want met, such as having the case report form entered within five days of the visit," Jones explains. "We talk with monitors and coordinators to make sure that metric is being met."
If a coordinator is not meeting the documentation goals, then site managers will work with the coordinator at better managing his or her time.
Sometimes a site will need to invest in a data entry employee who will enter case report forms for a coordinator who is busy handling high-enrolling studies.
5. Prevent morale problems.
While it's very important to evaluate study coordinators' work and skills, it's also important to motivate coordinators as part of a strategy to help them maintain their morale.
The research site also holds in-house drawings for movie tickets, dinner certificates, car washes, and other prizes. These drawings are held monthly and serve as rewards for coordinators who are the most productive, Jones adds.
It's also necessary to keep coordinators' workloads manageable.
"One of their biggest complaints is that their workload continues to increase, but their time for work doesn't," Jones explains. "So if you give a coordinator one big study, then you might give them another small study, or one coordinator might have four or five small studies."
Also, CT managers can give a highly-skilled coordinator an assistant who will do the time-consuming tasks, such as blood draws, obtaining vital signs, and case report form data entry.
"These are the time-consuming things that pull them away from the patient," Jones says. "The coordinator then will focus on finding patients and working with patients to make sure they understand the protocol."
6. Provide professional growth opportunities.
It's also important for study coordinators to have some professional mobility.
For instance, Rocky Mountain Diabetes Center has a position called the lead coordinator that the most experienced study coordinator can become.
"Also, we do quite a bit of intern work with physician assistants and pre-med students and medical assistance students, and we put experienced coordinators with them as their mentors," Jones says.
After coordinators have been working for the site for a couple of years then they can take a certification exam, and the site will give them a pay increase if they become certified.
"We'll assist them with their certification renewal, whether it's through assisting them with funding of continuing education or attending conferences," Jones says.
Like other rural areas in the United States, the Rocky Mountain Diabetes and Osteoporosis Center in Idaho Falls, ID, sometimes has trouble finding study coordinators.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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