National Credential
Credential: Certified Clinical Research Associate (CCRA)  In-Demand resource  GI Bill resource  NCCA resource
Credentialing Agency: Association of Clinical Research Professionals (ACRP)

The Association of Clinical Research Professionals (ACRP), Clinical Research Associate Certification (CRA) is a professional certification offered by ACRP. CRAs supervise, monitor, and support the administration and progress of clinical trials with the goal of researching pharmaceuticals, biologics, or devices. Applicants must have a general knowledge of basic math, laboratory terminology, tests, and procedures in addition to specific job-related knowledge. Applicants must meet a combination of experience and educational requirements and pass a written exam. Applicants must also provide a detailed résumé with job descriptions which accurately reflect related experience.

More information can be found on the certifying agency's website.

Renewal Period: 2 years

Certified Clinical Research Associate (CCRA)

The following Army Occupations provide training and/or experience that contributes to attaining this credential:

Personnel Category Occupation Occupation Type Related As Promotion Points Skill Level Star Proponent Funded Gap Analysis
Enlisted 68W Combat Medic Specialist MOS other          
Enlisted M8 Drug and Alcohol Counseling ASI some          
Enlisted W1 Special Operations Combat Medic (SOCOM) ASI other          

Army Table Legend

Related As

The military occupations shown in this table are related to this credential in one of four ways: Most, Some, or Other.

Most: This credential is directly related to most of the major duties associated with the military occupation (at least 80%). Note that the credential may require additional education, training or experience before you are eligible for it.

Some: This credential is related to some tasks associated with the duties of the military occupation (related 80% to at least one or more critical tasks but less than 80% of all of the entire military occupation). Note that the credential may require additional education, training or experience before you are eligible for it.

Other: This credential is related to this military occupation, but is more advanced or specialized and therefore will likely require additional education, training, or experience.

Promotion Points Promotion Points icon

This credential has been approved for promotion points for this MOS towards promotion to Sergeant and Staff Sergeant. Clicking the Promotion Points icon will open a link to the promotion points fact sheet.

Skill Level Designation

Skill Level I: This skill level consists of all Soldiers in the ranks of Private (pay grade E-1) up to Specialist (pay grade E-4). Time in Service (TIS) is generally between initial entry and four Years of Service (YOS). This skill level is Entry-level positions requiring performance of tasks under direct supervision.

Institutional training:

  • Structured Self-Development (SSD) level I
  • Basic Leader Course (BLC)

Skill Level II: This skill level is obtained when promoted to Sergeant (paygrade E-5). TIS is generally between 4-8 YOS. Positions requiring performance of more difficult tasks under general supervision; and in some instances, involving supervision of Soldiers in SL1.

Institutional training:

  • Structured Self-Development (SSD) level II
  • Advance Leader Course (ALC)

Skill Level III: This skill level is obtained when promoted to Staff Sergeant (paygrade E-6). TIS is generally between 8-12 YOS. Positions requiring performance of still more difficult tasks and involving first line supervision of Soldiers in SL1 & SL2.

Institutional training:

  • Senior Leader Course (SLC)
  • Structured Self-Development (SSD) level III

Skill level IV: This skill level is obtained when promoted to the rank of Sergeant First Class (paygrade E-7). TIS is generally between 12-18 YOS. Positions requiring relatively detailed knowledge of all tasks specified for a given MOS, normally involving first-line supervision of Soldiers in SLs 1, 2, and 3, and involving managerial duties.

Institutional training:

  • Master Leader Course (MLC)
  • Structured Self-Development (SSD) level IV
  • Senior Enlisted Joint Professional Military Education (SEJPME) I Course

Skill level V: This skill level is obtained when promoted to the rank of Master Sergeant (paygrade E-8). TIS is generally between 18-22 YOS. Positions requiring direct and indirect leadership roles with expertise in company and battalion-level operations and competency across a given CMF, serving as members of a staff at every level in the Army, with a full understanding of the allocation of resources and their utilization in order to accomplish Army functions and missions.

Institutional training:

  • United States Army Sergeants Major Academy (USASMA)
  • Structured Self-Development (SSD) level V

Skill level VI: This skill level is obtained when promoted to the rank of Sergeants Major (paygrade E-9). TIS is generally between 22-30 YOS. Positions requiring organizational leadership roles with multi-dimensional expertise in units and teams on division, corps, and Army staffs, integrated with Joint, Interagency, Intergovernmental, and Multinational (JIIM) partners with a full understanding of the Force Generation process, operations at all echelons, and how the Army runs.

Star Credential Star icon

Star credentials are MOS enhancing, as designated by the Proponent. MOS enhancing credentials are directly related to an MOS or ASI, are taught either partially or completely as part of a Program of Instruction (POI), and improve the MOS technical proficiency.

Proponent Funded Funded icon

This icon indicates credentials which Soldiers may have funded through their MOS proponent. Some proponents offer credentialing opportunities in conjunction with military training and/or as part of MOS development beyond the training base.

Gap Analysis Has Analysis icon

A detailed analysis comparing the credential requirements to the military occupation has been completed. Click on the gap analysis icon to view the analysis page.

Certified Clinical Research Associate (CCRA)

Eligibility Requirements ()

Note: This credential may have multiple options for becoming eligible. Listed below are the minimum requirements based on the minimum degree required. To view other options, see the Eligibility tab.

  • Credential Prerequisite
  • Experience: 6000 hours
  • Education: High School Diploma/GED
  • Training
  • Membership
  • Other
  • Fee

Exam Requirements ()

  • Written Exam
  • Oral Exam
  • Practical Exam
  • Performance Assessment

Renewal Period: 2 years

  • Continuing Education
  • Exam
  • Continuing Education OR Exam
  • Fee
  • Other

Association of Clinical Research Professionals (ACRP)
500 Montgomery Street, Suite 800
Alexandria, VA  22314
Phone: 703-254-8100
Fax: 703-254-8101

Certified Clinical Research Associate (CCRA)

Applicant's must document cumulative performance of each of the following essential duties during the dates of employment listed on their application:

  • Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects;
  • Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC;
  • Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)
  • Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools);
  • Ensure accountability of Investigational Product and related supplies are performed, when appropriate;
  • Ensure complete reporting and proper documentation of monitoring activities;
  • Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff;
  • Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.

Option 1: Bachelor's degree or higher with a minimum of 3,000 hours of directly related experience. Applicants must also submit a detailed resume/CV and job description.

Option 2: LPN, LVN, RN or Associate’s Degree with a minimum of 4,500 hours of directly related experience. Applicants must also submit a detailed resume/CV and job description.

Option 3: Medical Assistant, Lab Technician or High School Diploma with a minimum of 6,000 hours of directly related experience. Applicants must also submit a detailed resume/CV and job description.

Certified Clinical Research Associate (CCRA)

  • Scientific Concepts and Research Design (12%)
    • Components of a product development plan
    • Elements of a protocol
    • Elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use)
    • Elements of and rationale for subject eligibility requirements
    • Rationale for complying with a protocol
    • Study design characteristics
    • Study objective(s) and end points/outcomes
    • Use of supplemental/rescue/comparator product in study design
    • Treatment assignments
  • Ethical and Participant Safety Considerations (20%)
    • Adverse events classification, documentation and reporting
    • Blinding procedures
    • Components of subject eligibility requirements
    • Confidentiality and privacy requirements
    • Elements of the IB
    • Elements of the informed consent form
    • Informed consent process requirements
    • Protection of human subjects
    • Protocol deviation/violation identification, documentation, and reporting processes
    • Recruitment plan/strategies
    • Safety monitoring
    • Subject discontinuation criteria/procedures
    • Subject retention strategies
    • Subject safety issues
    • Vulnerable subject populations
    • Conflicts of interest in clinical research
  • Product Development and Regulation (10%)
    • Audit and inspection processes
    • Clinical development process
    • Elements of fraud and misconduct
    • IRB/IEC reporting requirements
    • IRB/IEC role, composition and purpose
    • Product development lifecycle
    • Protocol and protocol amendment submission and approval processes
    • Regulatory reporting requirements
    • Safety reporting requirements
    • Significant milestones in the evaluation of efficacy and safety
  • Clinical Trial Operations (GCPs) (25%)
    • Delegation of responsibilities
    • Elements of an effective corrective and preventive action (CAPA) plan
    • Elements of and rationale for monitoring plan(s)
    • Elements of the investigator's brochure
    • Monitoring activities (source data review, source data verification)
    • Pre-study/site selection visit activities
    • Principal investigator responsibilities
    • Principles of risk based monitoring
    • Project feasibility considerations
    • Roles of various clinical trial entities
    • Site close-out activities
    • Site initiation activities
    • Site selection criteria
    • Staff Oversight
    • Staff qualifications
    • Staff training requirements
    • Study close-out activities
  • Study and Site Management (23%)
    • Communication documentation requirements
    • Corrective and preventive action (CAPA) process(es) and plans
    • Equipment and supplies use and maintenance
    • Investigational product accountability and documentation requirements
    • Investigational product characteristics (e.g., mechanism of action, stability, etc.)
    • Investigational product labeling requirements
    • Investigational product packaging
    • Investigational product reference materials
    • Investigational product shipment
    • Investigational product storage
    • Non-compliance management
    • Project timelines
    • Purpose of and process(es) for protocol compliance
    • Roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority, etc.)
    • Sample collection, shipment, and storage requirements
    • Subject compliance assessment
    • Subject responsibilities for study participation
    • Subject visit activities
  • Data Management and Informatics (10%)
    • Data management activities
    • Data privacy principles
    • Elements and purposes of data collection tools (e.g., eCRF, EDC)
    • Elements of and process for data query
    • Elements of pharmacovigilance (e.g., CIOMS, IDMC/DSMB, safety databases)
    • Essential documents for the conduct of a clinical trial (e.g., trial master file)
    • Record retention and destruction practices and requirements
    • Source data review (SDR) and source data verification (SDV) purpose and process
    • Source documentation requirements
    • Study documentation practices (accurate, complete, timely, legible, dated, and identify the trial)

There are a number of resources available to help you prepare for the Certified Clinical Research Associate (CCRA) examination:

An additional resource is Safari Books Online, a searchable digital library that provides online access to thousands of books, training videos and conference sessions. See the Educational Resources page here on COOL to learn how to get free access.