Clinical Researcher—October 2024 (Volume 38, Issue 5)
ON THE JOB
John R. Nocero, PhD; Andrea L. Bordonaro, MAT
Research managers know how important research education is, but it’s easy to lose focus on workforce development goals at a study site when enrollment is down, protocol deviations are up, queries are unresolved, and monitors are breathing down your neck. It’s funny—conducting clinical research in today’s environment is like learning to drive, except that you don’t learn by maneuvering your dad’s Oldsmobile Cutlass through pre-arranged orange cones with a calm and supportive instructor belted in next to you. You gain your experience alone at night, careening through the snow on an icy bridge.
Managers today want new employees to come in and hit the ground running, but you need to spend time up front with these individuals—whether they are research-naïve newbies or seasoned veterans—to get a return on your investment in them. That means defining a full research training and development program tailored to your site to ensure all employees are appropriately trained on applicable regulations, guidelines, policies, standard operating procedures (SOPs), and study-specific tasks.
What’s more, the necessary effort doesn’t stop at onboarding. There needs to be a continuing education component, too—one building upon an employee’s skills to keep them learning and growing.
A complete and robust research education and training program includes onboarding, a plan for an employee’s first 90 days, and resources for continuing education as they progress at your company. Here’s how to build one.
Onboarding
Your company should require all employees to go through a new hire orientation process, which should be facilitated in some combination by Human Resources, the Quality Department, and Training and Education. There are some basic components that this process should cover, from both employee conduct and organizational administrative perspectives.
Research conduct should cover a high-level overview of clinical research at the site, including workflow from study-start-up to closeout; a review of Good Documentation Practice (GDP), including an overview of the ALCOA+ principles for data integrity; and the International Council for Harmonization’s tenets for Good Clinical Practice (GCP) (soon to be updated). An overview of the Collaborative Institutional Training Initiative (CITI Program) training on research, ethics, compliance, and safety and a high-level review of the site’s quality management systems and other administrative materials should also be covered.
This is a difference from many onboarding programs currently in place focusing on a review of the company history and signing off on the employee handbook. Yes, those are important, but if managers have the expectation that employees are ready once they get to the site, onboarding training needs to be set up to align with role-specific training.
Role-Specific Training
A training matrix should be used to determine the training materials new hires must complete. These may come in the form of SOPs, work instructions, or user guides. The focus here goes from “Did they read our SOPs?” to “Do they understand our SOPs and can they carry them out as directed?”
There is the standard fare here that we are sure a lot of you already do do—review of the regulatory logs and protocols, for example, or obtaining life support certifications that you put in the study binder. However, these are not the items that cause sites to get an FDA Form 483 from the U.S. Food and Drug Administration; what does is not protecting participant safety or data integrity.
Reinforce the workflow of the clinical research process among your staff, stressing attention to GCP, GDP, and the ALCOA+ principles to reconnect new hires back to the priorities for participant safety and data integrity. It’s why we are here. So that’s where your focus should be, but you have to reinforce the lessons learned in onboarding.
Ensure the new employee has a preceptor to help them during protocol reviews and who can sit in with them while they conduct their first informed consent interview, enter data into the data capture system, or build the regulatory binder. A preceptor is an individual with demonstrated competence in a specific area who guides, assesses, and validates the knowledge, skills, and attitudes needed to transition to a new role, specialty, or environment in the healthcare setting. Preceptors are integral to the orientation and onboarding of new staff and staff transitioning to a new role or department, as well as for students’ clinical experiences.
It doesn’t matter how many years of experience their resume says they have. Going back to the driving analogy—all employees will perform to the basic level of their training. And if this basic level of training comes from another company, they don’t know how to do things YOUR way; they are performing the way another company taught them.
Develop the competencies that cover the areas in which you need your employees to demonstrate knowledge. Write it all out and document it. But you are still not done. You need to have a plan for ongoing education.
Ongoing Education
Managers—how often have you tried to get rid of an underperforming employee only for Human Resources to ask you for documentation on their declining performance that you don’t have? How often have you later regretted giving someone a “Meets Expectations” on their last evaluation, knowing they didn’t really deserve it? Flip this script. Have weekly ongoing discussions with your employees. Find out where their educational gaps are and then give them resources—either internally within your Quality Department or externally from sources such as the Association of Clinical Research Professionals and Save Our Sites. Development of your employees is your responsibility. Invest in them for your organization’s future.
At a minimum, all research staff should complete biannual training on GCP and GDP, with clinical staff completing Advanced Cardiovascular Life Support or Basic Life Support training as needed to maintain their certification.
Conclusion
We are not telling you anything you don’t already know. But we are reinforcing that a focus on the basics is needed and can work. Rather than be triggered by the latest hack, weave the basics above into your work and nurture them throughout your employee’s professional careers.
John R. Nocero, PhD, and Andrea L. Bordonaro, MAT, blog on LinkedIn as “The Q-Kids,” discussing everything related to clinical research education, inspiration, and professional connection.
