The Association of Clinical Research Professionals

CCRA Exam Committee

The Global CCRA® Exam Committee uses psychometrically sound practices to develop Certified Clinical Research Administrator (CCRA) 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 CCRA certification examinations. For further information on the Global CCRA Certification Exam Committee’s goals, objectives, key responsibilities, and meeting, please refer to the Committee Charge below.

Current CCRA Global Exam Committee Members

Pam Dellea-Giltner, CCRA
(Chair)

President
PDG Clinical Consulting, LLC
Minden, NV
Term 2/Year 3

Sofia Keim, CCRA
(Vice Chair)
Global Trial Manager
Janssen Pharmaceutical Companies of Johnson & Johnson
Barcarena, Portugal
Term 2/ Year 3

Linda Hunt, MSc, CCRA
Regional CRA Manager for Quebec and Western Canada
Boehringer Ingelheim Canada Ltd
Stittsville, Ontario
Term 1/ Year 2

Lisa Ince, BS, CCRC, CCRA
Sr. CRA
Syneos Health
Phoenix, AZ
Term 1/ Year 2

Chie Narita, RN, BSN, CCRA
Research Specialist
National Center for Global Health and Medicine
Tokyo, Japan
Term 1/ Year 1

Nicki Tieken, MSHS, CCRA, ACRP-CP
Independent Sr Clinical Trials Consultant
Ferraro Consulting, Inc
Grapevine, TX
Term 1/ Year 1

ACRP Staff Liaison:
Giovanna Lancaster, Certification Director
glancaster@acrpnet.org
703-254-8103

Committee Charge

The mission of the Global CCRA Exam Committee is to use psychometrically sound practices to develop Certified Clinical Research Associate (CCRA) 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 Associate (CCRA) 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 (oral) 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 CCRA 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 CCRA certification.
  • The demographic makeup of committee members will be based on the relative demographics of
    exam candidates and shall include proportionate representation from CRO’s and pharmaceutical
    companies; 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:

    • Completion of item writer training
    • Familiarity with ICH GCPs and other applicable regulatory documents
    • Have current CCRA certification
    • 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 CCRA Exam Committee Vice Chair is responsible for leadership and facilitating the work of the committee.

Role 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 as Chair by the
    Academy Board for an additional one-year term.

Meeting Schedule

The Global CCRA Exam Committee will meet face-to-face three times per year; dates and locations for the coming year will be determined at the October 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 for 2018

  • Focus on recruitment for committee members the first quarter of 2018
  • Ensure an adequate number of items in the usable item bank by holding at least one (1) holding
    an item writing training session at the Global Conference and one (1) sponsored by a Chapter
  • Add 100 pretest questions to the item bank
  • Make recommendation to the Academy Board for additional approved reference sources
  • Approve two new forms of the exam for Spring 2018 Exam Cycle
  • Approve two new forms of the exam for the Fall 2018 Exam Cycle