The Association of Clinical Research Professionals

Core Competency Guidelines for Clinical Research Coordinators (CRCs)

ACRP is pleased to provide the clinical research enterprise with the industry’s first competency guidelines for Clinical Research Coordinators (CRCs).

 

Download Guidelines

Why We Need Competency Guidelines

Variance is the enemy of quality. The ad hoc manner in which we hire and train CRCs is failing to improve quality in clinical research conduct, as clearly evidenced by the persistence of negative FDA and global regulatory agency findings. We are also failing those at the front lines of clinical research by leaving them without consensus guidance on what we expect from them in terms of knowledge, skills, and attributes necessary to perform their jobs effectively, and how they can grow in their careers. We hope these guidelines will provide CRCs with the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research enterprise.

How They Were Developed

Developed by a task force of diverse industry representatives, the guidelines directly map to Version 2.0 of the Harmonized Core Competency Framework developed by the Joint Task Force (JTF) for Clinical Trial Competency (More Info).

Through extensive vetting—along with review and comments from ACRP’s Workforce Innovation Steering Committee—the guidelines were developed to provide the most far ranging set of competencies required by the broadest set of CRCs working across different types of clinical studies (investigational products, therapeutic areas and indications). In essence, we have attempted to create a robust library of competency guidelines from which individual organizations can select and choose those that are most relevant for the job roles and levels within their companies.

In all cases, efforts were made to translate the exact JTF competency statements into meaningful, practical, and measurable statements (including a combination of knowledge assessments and other behavioral descriptors). It should be noted that:

  • Many tasks that CRCs are required to perform can be more easily mapped to the competency statements, whereas in other cases interpretation was required to apply the intent of the competencies and relate these to the typical roles of the CRC.
  • In one case, the actual competency statement was modified to add additional wording to highlight the importance of study administration in addition to study design: Competency Statement 1:3 was re-worded to state: Identify the elements and explain the principles and processes of designing, implementing, and conducting a clinical study.

Several assumptions and caveats were also applied:

  • The terms patients, subjects, study participants are used interchangeably throughout.
  • The term study team members relate to all of the site personnel who contribute to the conduct of a clinical research study.
  • The JTF preferred term of clinical “study or studies” vs. trial, trials or protocols was used throughout.  We recognize however, that these terms can be used interchangeably depending on the context for the type of clinical research being conducted.  As such, the primary emphasis of the competencies reflects CRCs working in investigational clinical studies and that adaptations will necessarily be needed for behavioral health interventions, investigator-initiated trials, and other government-funded studies.
  • While it is recognized that as CRCs gain more experience, they will likely become involved in trials that are more complex.  However, as there are no industry-accepted definitions or standard ways to measure protocol complexity, the competency levels are not linked to levels of protocol complexity.
  • No attempt was made to address the nursing or clinical care-related aspects performed by some CRCs, as other organizations are focusing on developing competency guidelines for clinical research nurses or CRNs.
  • The competencies were written with the understanding that advancing level of the job role (from entry-level CRC to immediate-level CRC to senior CRC) recognizes that all of the prior competencies have been achieved.

 

It is ACRP’s hope that this initial set of guidelines serves as a strong foundation from which diverse organizations across the globe can adapt to their specific institutional guidelines.

 

Inevitably, modifications will be required to accommodate different types of sites (e.g., academic health centers, dedicated research facilities, site networks and other models), across different regions, countries, and local ethical and regulatory requirements. We recognize that this will be a work in progress and the guidelines will undergo many iterations once they are in more widespread use.

Forthcoming editions will provide links to ACRP training programs that can be accessed to close any competency gaps, recommendations for creating competency-based job descriptions, performance assessment tools, and more.

How You Can Get Involved

We are eager to hear how you have applied and adapted these guidelines, and welcome all comments and suggestions that can be incorporated into future versions.

Please email Beth Harper, ACRP Workforce Innovation Officer, at beth.harper@acrpnet.org, to share your feedback.

A Special ‘Thank You’ to Our Collaborators

We are grateful for the contributions of Workforce Innovation Steering Committee Members from…

  • Amgen
  • BioClinica
  • Children’s Mercy – Kansas City
  • Duke University School of Medicine
  • Genentech
  • Greater Gift Initiative
  • Lurie Children’s Hospital of Chicago
  • Medix
  • Medtronic
  • Pfizer
  • PMG-Research
  • PPD
  • The Department of Veterans Affairs

… And Task Force Representatives from:

  • Amita Health
  • Apex Medical Research
  • Ascension Wisconsin
  • Aurora BayCare Medical Center
  • Boston Scientific
  • Coalition of Cancer Cooperative Groups
  • Cystic Fibrosis Foundation
  • Elligo Health
  • Fred Hutchison Cancer Research Center
  • Greater Gift Initiative
  • In-Quest Medical Research
  • IQVIA (Quintiles IMS Qcare)
  • LMC | Manna Research
  • Minnesota Gastroenterology
  • Monash University
  • Northwell Health
  • Novant Health
  • Ohio Health Research & Innovation Institute
  • PPD Laboratories
  • Rutgers University
  • Spaulding Clinical
  • St. Lukes Health System
  • The Juvenile Diabetes Research Foundation
  • The University of Louisville
  • The University of Michigan
  • The University of California – Irvine
  • The University of Colorado
  • The University of Rochester Medical Center
  • Unified Women’s Clinical Research