Eligibility for the CCRA Program

The CCRA® eligibility criteria define the minimum experience required before a CRA can apply for the program. It is important to compare the CRA eligibility criteria with your career and educational experiences to self-determine your eligibility before submitting an application and payment. All applications must undergo a formal review process to determine an applicant’s eligibility to sit for the exam.

Definition of a CRA
A clinical research associate (CRA), regardless of job title, supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract research organizations (CROs), or as independent consultants or contractors.

CRA Certification Eligibility Requirements
In order to be deemed eligible to take the CCRA® exam, applicants for the CCRA® credential must be able to provide evidence through a job description, detailed CV, or other documentation that they:

  • Work independently of the investigative staff conducting the research at the site or institution.  This means they do not report to the PI or site manager and that they do not have the ability to change or manipulate data,  and;
  • Work on behalf of the sponsor.  This means that they are contracted by the “sponsor” to perform an independent monitoring function.  The “sponsor” can be a pharmaceutical or device company, a granting agency, a university department, a physician, etc., and;
  • Perform all of the CCRA® essential duties as detailed below for a required minimum number of hours. Hours performing the CRA essential duties can include hours documented up to the date of the exam and/or through previous employment. The required number of hours is dependent upon one’s educational background.

The CRA Certification Handbook has complete information on eligibility requirements.

CRA Essential Duties
As defined by the Academy, and determined through ACRP’s 2010 Job Analysis Survey, clinical research associates who are eligible for CRA Certification must document cumulative performance of each of the following essential duties during the dates of employment listed on the application:

  • Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements;
  • Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
  • Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);
  • Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);
  • Verify Investigational Product accountability;
  • Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);
  • Conduct routine monitoring visits on behalf of the clinical trial sponsor.

The above essential duties must have been performed for a cumulative 3,000 – 6,000 hours, depending on the applicant’s education background, as shown in the following chart:


CCRA® Eligibility Requirements
At least one of the eligibility requirement options below should be met before applying for the CCRA® program.

 

 

Education

 

Minimum Hours Performing Essential Duties

 

Required Documentation
of Performed
Essential Duties

 

Option 1

 

  • Bachelor’s degree (or higher) or
  • Registered Nurse (RN)

 

3,000 hours*

 

Detailed CV/resume
and
Job Description

 

Option 2

 

  • Associate’s degree

 

4,500 hours*

 

Detailed CV/Resume
and
Job Description

 

Option 3

 

  • Other, such as LPN, LVN, Medical Assistant, Lab Technician  

                or

  • High School diploma

 

 

6,000 hours*

 

Detailed CV/Resume
and
Job Description

Clinical Research Education Programs
The Academy considers applicants who have completed a clinical research education program that meets the following standards to have achieved a valid substitute for 1,500 hours of professional experience performing the CRA essential duties.
Acceptable programs must:

  • Be at least 216 hours in length and;
  • Cover content that substantially maps to the topics found on the current CRA Detailed Content Outline (DCO) and;
  • Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation (CHEA). A list of recognized accrediting agencies can be found from the CHEA website: www.chea.org/search.

If an applicant submits an application using an educational program as a substitute for 1,500 hours of CRA work experience, then the following information must be included on the applicant’s CV and a certificate of completion must also be submitted:

  • Name of school
  • City and country in which the school is located
  • Program title
  • Name of organization that accredits the institution providing the program
  • Dates attended (e.g., From-To)

If you have determined that you meet the eligibility criteria, the next step is to submit an application with payment:

The Eligibility Review process includes determining completeness of the application and determining whether or not the applicant meets the eligibility criteria for the exam. This process begins within one week of receiving the application and may take up to two weeks to review before any update is emailed.

It is not unusual for an applicant to receive a request for additional and/or clarifying information from an Eligibility Reviewer. These requests will come via e-mail. Applicants will have seven (7) calendar days to respond to the request. Applicants who do not respond to the request for additional or clarifying information will automatically have their applications determined incomplete and therefore are ineligible to take the exam. Ineligible applicants will be refunded the exam fee only.

Confirmation of Eligibility and Testing Information
If an applicant is determined to be eligible after the application has been reviewed, the candidate will be e-mailed an Eligibility Notice, with further instructions as to how to schedule his/her exam appointment.

Note: check your SPAM or Junk mail folder if you do not receive any notice within 14 days of applying.

If an applicant is determined to be ineligible during initial review, the application is automatically reviewed by a second reviewer. If the second reviewer also determines the applicant to be ineligible, the application is automatically sent to the Director of Certification for a third review. Applicants are notified via e-mail at each step of the review with an explanation of the deficiency identified.

If, after the three (3) levels of review, the applicant is still determined to be ineligible, the applicant can choose to appeal to the Academy Board of Trustees. However, after the third level of review by the Director of Certification, applicants can no longer submit new documents to overturn an eligibility decision.

Applicants found to be ineligible who do not initiate the Appeals process within the stipulated timeframe will automatically be refunded the exam fee.

See the Certification Handbook for complete details of the Eligibility Review Process.

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