Professionalize Your Clinical Research Personnel

By Ed Miseta, Chief Editor, Clinical Leader

Clinical research professionals need to be properly educated and trained to ensure regulatory compliance, subject safety, and data integrity. A strong knowledge base facilitates quicker approvals and fewer trial delays.

But how does your staff get the training needed to develop the skills most in demand? And from where is formal education coming? When training opportunities are available, how do you ensure employees learn from them and that you see tangible results? These are questions facing the industry that the Association of Clinical Research Professionals (ACRP) is addressing.

“We are trying to train professionals in a manner that is performance-based,” says James Thomasell, executive director of ACRP. “We want to train them the right way the first time, so we can get people to conduct research in the most ethical, responsible, and effective manner possible.”

People have historically entered clinical research from a host of other professions, due primarily to a lack of educational opportunities available in post-secondary education.

James Thomasell, executive director, ACRP

“If you wanted to be a nurse, you would go to a college or university and obtain a degree in nursing,” says Thomasell. “That degree would let everyone in the industry know you have the requisite education to enter the field. There is a defined career path that you know to take, and there are additional certifications available to further demonstrate your expertise in specialty areas.”

Thomasell would like to see a similar model gain traction in the future to help professionalize clinical research.

By “professionalize,” Thomasell is referring in part to efforts to establish a set of core competencies that can be gained through education; demonstration of the knowledge, skills, and abilities required to perform a specific role in clinical research; as well as ongoing proactive training to ensure continued professional development.

To address development of core competencies through education, ACRP is supporting the Consortium of Academic Programs in Clinical Research in its efforts to develop and maintain academically based, accredited clinical research education programs.

Addressing the Training Dilemma

The training models used in clinical research can vary across organizations, with some focusing on internal programs and others looking externally. An abundance of training options exist and are utilized; yet audit and inspection findings persist, and continue to focus on the same common issues, such as protocol compliance, record keeping, drug accountability, and so on. 

When training clinical personnel, that training can generally occur two ways. Training can be performed proactively, or on the front end. For example, a new employee can be trained on how to perform a certain task in a manner that meets all internal and regulatory quality standards. This ensures all employees are knowledgeable and performing their jobs to established standards. Another option might be to train employees on the basics, and then provide some type of additional training if a bad audit or inspection deems it necessary.   

A lack of proper training can certainly have an impact on CROs, especially if any shortcomings are noted via inspections by regulatory agencies or clients. Training can be a challenge because it is not always easy to locate the proper courses, with knowledgeable instructors, offering the training in a manner that is convenient to both CROs and their employees. A lack of training can also result in a shortage of properly trained individuals, which could potentially contribute to the number of errors occurring.

Training Involves Changing Behaviors

For training to be effective it must attempt to get participants to change their behavior. Thomasell notes the best training has a focus on how to impact the way someone performs their work. The ACRP programs seek to engage the learner throughout the online training experience and even provide tools participants can download and use after the training is complete. These tools assist attendees with recalling and applying what they have learned in the sessions.  

Professionalizing the work of clinical researchers will also be a priority moving forward. While a student entering college today may not be able to choose clinical research as a major, Thomasell notes there are already Master’s and PhD programs available in clinical research.  Although not currently accredited, ACRP would like to see these programs move in that direction.  

After just two years of experience clinicians can be certified by ACRP and maintain that certification throughout their career in research. The three primary areas in which ACRP provides training and certification are Principle Investigator, Clinical Research Coordinator, and Clinical Research Associate/Monitor. For those folks getting increasingly involved in the management of trials and employees performing trials, the organization now offers training in project management as well, encompassing regulatory compliance, regulatory affairs, and executive management.

“ACRP views certification as the capstone in professionalizing clinical research,” says Thomasell, “It provides an objective measure to verify that an individual’s education, training, and experience has translated to the ability to safely and effectively conduct clinical research.”