The Association of Clinical Research Professionals

CCRC Exam Committee

The Global CCRC® Exam Committee uses psychometrically sound practices to develop Certified Clinical Research Coordinator (CCRC®) examinations that meet the current test specifications as determined by the most recent Job Task Analysis (JTA). Committee members will provide content expertise to the ongoing development of the CCRC® certification examinations. For further information on the Global CCRC® Exam Committee’s goals, objectives, key responsibilities, and meeting schedule, please refer to the Committee Charge below.

2024 CCRC® Global Exam Committee Members

Alisha Daniels, MD, MHA, CCRC, CCRP
(Chair)
DIAN Study Executive Director
Washington University in St. Louis
St. Louis, MO
Term 2 / Year 3

Patricia Burks, RN, MA, CCRC
(Vice-Chair)

Director of Clinical Trial Affairs
Cystic Fibrosis Foundation
Bethesda, MD
Term 2 / Year 3

Mary Checovich, MS, CCRC
Senior Research Specialist
University of Wisconsin
Madison, WI
Term 2 / Year 3

Susan D. Donahue, CCRC, ACRP-PM
Senior Director, Operational Quality
Javara Inc.
Lexington, NC
Term 2 / Year 3

Hubert Lesur, CCRC
QA-GCP Au
HL Health Support
Paris, France
Term 2 / Year 2

Stephanie Mullin, RN, BSN, PHN, CCRC
Research Coordinator Supervisor
University of Southern California
Division of Cardiothoracic Surgery
Los Angeles, CA
Term 3 / Year 1

Ashley Smith, RN, CCRC
Clinical Research Coordinator
Holston Medical Group
Bristol, TN
Term 2 / Year 2

ACRP Staff Liaison:
Steven Gonzalez, ICE-CCP
steven.gonzalez@acrpnet.org
703-258-3505

Committee Charge

The mission of the Global CCRC Exam Committee is to use psychometrically sound practices to develop Certified Clinical Research Coordinator (CCRC) examinations that meet the current test specifications as determined by the most recent Job Task Analysis (JTA).

Global Goals and Objectives

Committee members will provide content expertise to the ongoing development of the Certified Clinical Research Coordinator certification examinations. The committee will:

  • Maintain the confidentiality and integrity of the examination.
  • Assure an adequate pool of exam items for potential inclusion on the written examination.
  • Review and approve items, ensuring each item: tests appropriate skill level; topic found on the Detailed Content Outline (DCO); has a viable reference; is keyed correctly; is appropriate for all segments of the candidate population in terms of context, setting, language, descriptions and terminology; is free of bias or stereotyping .
  • Identify, through review of the item bank by content area, topics in the DCO that are underrepresented in the item bank for future assignment to item writers.
  • Review and approve exam forms for administration to the candidate population.
  • Review, approve and retire items for the Exam Practice Exercise tool.
  • Review, revise and evaluate draft items submitted by Item Writers/Subject Matter Experts for potential inclusion as pre-test items.
  • Write items, as necessary, for the examination; provide item references or rationales; submit in a timely manner.
  • Serve as a global ambassador to promote the profession and ACRP certification of CCRCs, CCRAs, and CPIs.
  • Serve as global ambassador of ACRP as the premier membership organization of clinical research and promote membership in ACRP.

Authority

The scope of the Global CCRC Exam Committee is to develop and deliver psychometrically sound exams that will yield fair and balanced certification examinations for all stakeholders.

Function

It is critical that committee members devote sufficient time to participate in and contribute to committee activities.

Committee Members:

  • Consist of at least six but not more than eight members.
  • Must hold current CCRC certification.
  • The demographic makeup of committee members will be based on the relative demographics of exam candidates and shall include proportionate representation from Academic institutions, private physician practice, hospital settings, and investigational drugs/biologics and devices; and geography. Multiple representations may be satisfied from one or more committee members.
  • All members are chosen for their recognized expertise and are selected to fulfill the expertise needs as identified in the committee’s annual survey.
  • Leadership will entail a committee chair and a vice chair.

Skills and Expertise:

  • Committee members must keep current with changes and trends in clinical research.
  • Committee members must be currently involved in the actual conduct of a clinical trial.
  • The Committee will define on an annual basis any additional skills and expertise areas required for service on the committee. Minimum expertise requirements will include:
    • Hold current CCRC certification
    • Completion of item writing
    • Familiarity with ICH GCPs and other applicable regulatory documents
    • Effective working in a team environment and independently
    • Ability to meet, face-to-face three times a year
    • Ability to take the certification examination two times per year
    • Ability to solve problems and prioritize tasks
    • Demonstrate good oral and written communication skills.

Role of Chair

The Committee Chair is responsible for leadership and facilitating the work of the committee and working with the Staff liaison to develop the meeting agenda.

Role of Vice Chair

In the absence of the Chair, the Global CCRC Exam Committee Vice Chair is responsible for leadership and facilitating the work of the committee.

Roll of Staff Liaison

The Staff Liaison provides all necessary support to the Chair, Vice Chair, and all the committee members to facilitate the work of the committee, including setting up meetings and helping to prepare the materials.

Staff Liaison: Certification Manager

Term Length:

  • Committee members will serve one, three-year term with an option to serve one additional sequential term of three years.
  • Members may return to serving the committee, per the needs of the committee, after a two year break in service.
  • If an individual has served two, three-year terms, he/she may be appointed for an additional one-year term at the discretion of the Academy Board Chair if it serves the best interest of the entire exam committee.

Meeting Schedule

The Global CCRC Exam Committee will meet face-to-face three times per year; dates and locations for the coming year will be determined at the September meeting each year.  Teleconference calls may be conducted as necessary.  All meetings will be supported financially by the Academy.

Accountability

  • Informal reporting about the committee’s activities will occur quarterly to the Academy Board.
  • An annual report will be submitted to the Academy Board.
  • The committee’s work will be aligned with the ACRP Strategic Plan.

Annual Goals

  • Focus on recruiting committee members the first of quarter
  • Ensure an adequate number of items in the usable item bank by holding at least one (1) item writing training session at the Meeting & Expo and one (1) sponsored by a Chapter
  • Add 100 pretest questions to the item bank
  • Makes recommendation to the Academy Board for additional approved reference sources
  • Approve two new forms of the exam for the Spring Exam Cycle
  • Approve two new forms of the exam of the Fall Exam Cycle