Develop comprehensive hiring and training plan for new staff at a clinical research site

Expert offers outline for competent hiring and training

Clinical research is more complex these days, and so is the hiring process. Clinical trials sites and others in the industry now have a variety of options when hiring new personnel, including the latest option of hiring staff that are fresh out of a clinical research degree program.

As such, it's a good idea to review the hiring and training objectives and update and revise these where necessary, an expert advises.

"Over the last two years, we've implemented a position-specific training program," says Kathleen S. Badeaux, MS, CCRA, clinical research associate for MedTrials Inc. of Dallas. MedTrials is a clinical research organization, and Badeaux spoke about creating a training needs analysis and resultant training matrix at the Drug Information Association's 42nd annual meeting, held June 18-22, 2006, in Philadelphia.

"Our training program is created at the organizational level, but it can be individualized for each employee based on the person's previous experience and/or education," Badeaux adds.

One way to do this is to create a training needs analysis that encompasses both initial employment and continuing education and training, Badeaux says.

Badeaux explains how to create such an analysis, as follows:

1. Write a detailed job description.

"We saw a need for ongoing training in our organization, and so we thought the best way to address that issue would be to address it according to the job description," Badeaux says.

An institution's or company's job descriptions should be made at the organizational level in which the company decides what basic knowledge, skills, and abilities they want in each job, Badeaux suggests.

"Our job descriptions are pretty extensive," Badeaux notes. "To have a thorough job description, it has to be done at the highest managerial levels."

The key is to identify first the skills required to help the company meet its own goals, she says.

"Then hopefully, your position's job description will follow from that," Badeaux adds.

The MedTrials' job descriptions typically are two pages long and include job functions and qualifications, which increase in length as the job level increases.

For instance, a job function description for a clinical research associate (CRA) level 1 position will be shorter than the job function description for a CRA level 3 because the level 3 description includes the same function descriptions noted in levels 1 and 2, plus additional items, she explains.

"Our qualifications are very specific initially, and then they become more general," Badeaux says.

Also, there is some flexibility in hiring objectives.

For example, for a CRA level 1, the typical job function requirement is for the employee to have two years previous clinical research experience, Badeaux says.

"But a lot of times we'll hire someone and let them be an in-house CRA where they can learn the nuts and bolts of the job, work with filing and document management until they have a firm understanding of the regulations, and then they can start looking at monitoring reports from other CRAs," Badeaux says. "They are responsible for filing those and tracking them, and they're exposed to a lot of the facets of the CRA level 1 position, and then they can go out and co-monitor with a CRA before becoming a CRA themselves."

For higher CRA levels, the years of experience requirements are less flexible, she adds.

"We also require degrees and want at least a bachelor's degree, although many of our employees have higher degrees," Badeaux says. "We usually require CRA certification for levels 2 and, especially, 3."

The skills required are built from there, including managerial skills, drug and device experience, communication skills, and organizational skills, she says.

2. Divide potential employees according to experience.

"We take the core competencies required in the job description and we correlate those with the experience and education each individual brings to the job," Badeaux says.

"We do a functional analysis and look for employees' demonstrable skills and individual differences in past training, any pre-conceived ideas they bring with them, and their level of motivation," she explains.

Using a CRA level 1 as an example, MedTrials would expect the new employee's knowledge to include competency in good clinical practices (GCPs), all research regulations, guidelines, industry standards, and company or project/sponsor-specific standard operating procedures (SOPs), Badeaux says.

"So that's the general knowledge that we want for a CRA level 1," she adds.

A new hire's past experience usually falls into one of four categories:

  • Position experience — This requires shorter training time, less training expense, quicker productivity, possible bias, and higher salary;
  • Industry experience — This employee would need medium training time, moderate training expense, quick productivity, possible bias, and moderate salary;
  • Inexperienced/CR education — This employee will need medium to extensive training time, moderate training expense, reasonable productivity, minimal bias, low to moderate salary;
  • Inexperienced/no CR education — For this employee, the training time and expense are extensive, and there is delayed productivity, but no bias, and a low salary.

3. Know your own organization's goals.

A company must know what needs to be accomplished, what's driving the company's goals, and the job description should flow from those goals, Badeaux says.

"The goals and job description represent what we want in our employees as representatives of our company," Badeaux says. "We have always prided ourselves on providing a quality product, so we stress quality, and that's why we implemented this type of training program to make sure when we hire people their work helps us provide the best possible product we can provide."

So for MedTrials, the job descriptions flow from the company's chief goal of producing a quality product for clients, she adds.

4. Make assumptions based on employee type.

Based on the four different types of employees, some basic assumptions can be made, Badeaux says.

"Each individual is different, so we want to give them a little bit of time to show us what they can do," she adds. "But we had to make basic assumptions when we designed specific educational modules, or we wouldn't know where to begin."

For example, for employees who already are CRAs, managers assume the new employees have knowledge about GCPs and industry practices, Badeaux says.

"Someone who has clinical research experience, but not as a monitor, probably has been exposed to GCPs, as has the graduate of a clinical research education program," she says. "But the completely inexperienced individual, who has no real monitoring experience, would probably not be conversant in GCPs, industry practices, or SOPs."

Another assumption would be that an experienced CRA would have some monitoring mechanics, would be computer proficient, and would have good communication skills, Badeaux says.

So when a company creates education and training requirements for new employees, it's important to chart according to an employee's assumed knowledge, skills, and abilities for each of the four types of education/experience scenarios, Badeaux says.

5. Document specific training dynamics based on perceived deficiencies.

Once basic assumptions are on paper about each position and level of experience, then it's time to chart training requirements for each scenario.

"So we started with CRA level 1 and developed a CRA level 1 book of knowledge," Badeaux explains.

This requires answering the question, 'What are the critical elements we want them to know to do their job?'

"What we came up with is we definitely wanted staff to be knowledgeable in GCP; we wanted them to know our company and project-specific SOPs," Badeaux says. "We also want them to possess specific monitoring skills, good communication techniques and soft skills, such as critical thinking skills."

The company also has specific ongoing job requirements and considerations for them as well, she adds. (See chart of position-specific training needs analysis.)

For example, these are some ongoing training considerations:

  • For inexperienced staff: Allow sufficient in-house time to develop familiarity with all aspects of clinical research and company policies, and provide training modules both before field monitoring has started and shortly thereafter;
  • For experienced staff, repeat initial and more advanced training modules at least once per year;
  • For all staff, provide resources and references for refresher courses and questions in field or in practice.

6. Provide staff education modules and position-specific training.

MedTrials' training sessions involve instructors who hold workshops lasting from one-half a day to two days in duration, Badeaux says.

Each workshop consists of modules, lasting from one hour to 1.5 hours.

"We have an outline of all of our modules, and we've identified how long they will run," she says.

All new monitors will take the interim monitoring workshop, and then they'll continue to take it as part of their continuing education, so they will always remain proficient in monitoring, Badeaux says.

"We allow two full days for the interim monitoring workshop, and we have seven sessions within that workshop," she says. "All four levels of staff take this workshop, and we tailor it to our way of doing monitoring."

MedTrials also provides inservices to help employees hone their hard and soft skills, including their communication skills and IT skills, Badeaux says.

"We also have weekly inservices where we provide continuing education to all employees," she notes. "Every Friday we have lunches provided to staff, and sometimes the inservices are based on federal regulations, therapeutic areas, or ethical issues."

"That's a real benefit to our organization and employees, and that's in addition to the formal modules we have," Badeaux adds.

Depending on an employee's education/training level and position, there will be a variety of other modules required. These additional modules include the topics of regulatory review and source document verification, Badeaux says.

Each required module is based on what the company expects the employee to be able to do on the job, she explains.

"The training program is about what we need to provide them so they can perform that job well," Badeaux says. "We want to make sure they will be able to perform their job to our standards and how we want it to be done."