In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce.1 To say that Jim has been obsessed about helping the industry understand the impact that variance in personnel performance has on the quality conduct of clinical research and ultimately, the patient experience, would be an understatement. In my capacity as ACRP’s workforce innovation officer, when discussing the topic, I often see lots of heads nodding in agreement about why we need competency standards. But the question that is most often raised is how. More specifically, I often hear:

  • I only hire staff with an X type of degree, a minimum of Y years of experience, who have taken Z number of courses to ensure that they are competent – what more do I need to do?

The question isn’t surprising really, when you consider that the fundamental expectations set forth in federal regulations and ICH GCP guidelines are that “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).”2 Our approach to the hiring and assessment of staff involved in conducting or overseeing clinical trials has traditionally been based solely on these strongly rooted tenets of education, training, and experience. But the reality is that this simply isn’t enough.

For example, while we have more academic programs offering certificates and undergraduate and graduate degrees than ever before, these individuals often struggle to secure entry-level jobs due to lack of practical, hands-on experience. So, education alone isn’t convincing enough for employers to bring folks on board and provide the necessary apprenticeships that could build upon their strong educational foundations.

Further, we know that tenure and experience don’t translate to competency and proficiency. How many stories have we heard, or how many failed hires have you had, where individuals with years of experience were engaged only to find they couldn’t perform at baseline levels of expectation?

Finally, many training programs don’t address the core competencies necessary to conduct clinical trials. Case in point, a recent article3 profiled a number of industry surveys that revealed many clinical research coordinators (CRCs) found their onboarding and training to be lacking in many of the competency domains outlined by the Joint Task Force for Clinical Trial Competency.4

Back to the how question … How do I assess and enhance the quality and competency of my workforce if education, training, and experience aren’t enough? Particularly when there are:

  • no mandatory regulations, standards, or licensure requirements for specific job roles within clinical research,
  • no accreditation requirements for academic programs, and
  • no standards for internal or external training programs?

First, it’s worth defining a few basic concepts: competency, credentialing, certificates, certification, and licensure.


Competency is generally defined as the ability to do something successfully or efficiently. In the workforce, definitions of competence include the ability to perform tasks and roles to the expected standard as well as having the skills and abilities needed to practice safely and effectively without the need for direct supervision. Competence focuses on performance: what someone does rather than just their knowledge and how they perform according to expected standards. Before one can evaluate against competency standards, those standards need to be defined. For the past five years or so, the Joint Task Force for Clinical Trial Competency4 has worked to define eight domains and nearly 50 competency statements resulting in the Harmonized Core Competency Framework, a universally applicable, globally relevant framework that identifies the competency domains and the associated cognitive skills necessary to conduct a high-quality, ethical, and safe clinical trial.


Credentialing is the umbrella term used for the many types of programs that exist, including licensure, certification, accreditation, recognition designation, and certificates. Some organizations use the term credentialing in place of, or as a synonym for, certification. The term “credentialing” is also used by hospitals and other healthcare organizations to describe the process through which a healthcare professional is determined to be qualified to have certain medical privileges at the institution. To say that someone is credentialed, then, is dependent on the context and how the organization using that term defines it. This is a source of perpetual confusion for many in our industry, so other terms are used to help differentiate types of qualifications, such as certificates, certification, and licensure.


Students attending certain training programs often earn certificates of attendance or participation. Attending a course does not necessarily translate into whether the student has demonstrated mastery of the intended learning outcomes. To ensure this is achieved, students must demonstrate that they have mastered certain skills, knowledge, or competencies. To be meaningful, the certificate should be awarded by an accredited organization, meaning that a school or course has met standards set by external regulators.


Certification is a voluntary process by which a nongovernmental entity grants a time-limited recognition to an individual after verifying that he or she has met predetermined and standardized criteria. This is voluntarily pursued by the individual and provided through an outside organization, after completing more training and testing requirements and completing other tasks specific to the governing rules of the certifying body. The maintenance of certification status is mandated by the specific organization offering the credential.

Are your oversight procedures in place?

Recent updates to ICH GCP E6 recognize the increase in remote clinical trials and outlines expectations for Investigator Oversight. Check out Sandra “SAM” Sather’s webinar, “Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum


Whereas certification is a voluntary process provided by a nongovernmental entity, licensure is mandatory process by which a governmental agency grants time-limited permission to an individual to engage in a given occupation after verifying that he or she has met predetermined and standardized criteria. Unlike requirements for nurses and physicians, currently no licensure requirements exist for clinical research professionals. And, as Jim aptly pointed out in his article, “We should be the ones to establish and enforce standards. If we aren’t careful, however, it leaves a tempting gap for the government to intervene and legislate something without significant industry input. That’s not a good scenario for anyone.”1

So where does this leave us? In an ideal world, perhaps:

  • Every entry-level clinical research professional would have a certificate or degree from an accredited school.
  • Every organization would have competency-based job descriptions defining the performance standards for all levels of the roles involved (entry-level, intermediate, and advanced).
  • All employers would provide competency-based mentoring programs and performance assessments to ensure staff progress in a standardized and structured manner to achieve higher levels of performance.
  • All clinical research professionals with a minimum of two years of experience would voluntarily pursue certification to demonstrate their commitment to professionalism, advanced knowledge, and competency.

From a practical standpoint, I encourage you all to take Jim’s challenge and start doing something, whether it’s starting up an apprenticeship program, revamping your job descriptions to be more competency-based, or promoting certification among your staff. If you haven’t checked us out in a while, ACRP has a growing number of competency-based tools to help you in your journey. From the Study Monitoring Competency Guidelines published last year to the soon-to-be published CRC Competency Guidelines and Pathways to Certification job aids, we are on a mission to offer a wider range of individual and employer workforce solutions. If that’s not enough, come hear Doug Schantz of Astra Zeneca and Jennifer Byrne, co-founder of Greater Gift Initiative and former CEO of PMG-Research, discuss how their organizations have used and are adopting competency-based approaches in the session Advances in Competence and Career Path Standardization Initiatives at the ACRP Meeting and Expo in April. We hope to see you there and look forward to hearing how you’ve taken the challenge!


About The Author:

Beth Harper is the president of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management. She is also serving as the workforce innovation officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Harper is an adjunct assistant professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment, and sponsor-site relationship management. She is currently serving on the CISCRP Advisory Board as well as the Clinical Leader Editorial Advisory Board, among other industry volunteer activities.

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