Certified Clinical Research Coordinator (CCRC)

Credit Recommendation

  • COM 326 - Organizational Communications: 3 credits, upper division level

  • HIM 410 - Health Care Database Design and Development: 3 credits, upper division level

  • Clinical Trial Operations: 6 credits, upper division level

  • Ethical and Participant Safety Procedures for Clinical Research Coordinators: 4 credits, upper division level

  • Leadership and Professionalism: 3 credits, upper division level

  • Product Development and Regulations in Clinical Research: 3 credits, upper division level

  • Scientific Concepts and Research Design: 3 credits, lower division level

  • Study and Site Management for Clinical Research: 4 credits, upper division level

Effective Dates 

January 2014 through December 2023

Issuing Agency

Association of Clinical Research Professionals (ACRP)

About the Credential

A Clinical Research Coordinator (CRC) works at a clinical research site, with study subjects, under the immediate direction of a principal investigator, whose research activities are conducted under good clinical practice guidelines. 

How to Apply for the Credit

Credit Recommendation Details / Competencies

COM 326 - Organizational Communications: 3 credits, upper division level

HIM 410 - Health Care Database Design and Development: 3 credits, upper division level

At least 80% of the content covered in the two (2) Charter Oak courses is verified by the CCRC credentialing process.  Charter Oak does not award duplicate credit for the same learning and the credit recommendations can only be applied once per student. 

Clinical Trial Operations: 6 credits, upper division level

  • Element of an effective corrective and preventive action processes and plans.

  • Elements of and rationale for monitory plans.

  • Indemnification / insurance requirements.

  • Monitoring activities such as frequency of visits, data review, and follow up.

  • 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 and initiation activities.

  • Site selection criteria.

  • Staff qualifications, training, and oversight.

  • Study close-out activities.

 

Ethical and Participant Safety Procedures for Clinical Research Coordinators: 4 credits, upper division level

  • Adverse events classification, documentation and reporting.

  • Blinding procedures.

  • Components of subject and eligibility requirements.

  • Confidentiality and privacy requirements.

  • Informed consent policies and procedures including forms and electronic consent (eConsent).

  • Elements of the investigators’ brochure.

  • Protection of human subjects.

  • Protocol deviation / violation identification, documentation, and reporting processes.

  • Subject safety monitoring and issues.

  • Subject recruitment plans / strategies as well as retention strategies.

  • Vulnerable subject populations.

  • Subject discontinuation criteria / procedures.

 

Leadership and Professionalism: 3 credits, upper division level

Encompasses the principles and practice of leadership and professionalism in clinical research, with the ability to:

  • Describe the principles and practices of leadership, management, and mentorship, and apply them within the working environment of clinical research.

  • Identify and implement procedures for the prevention or management of the ethical and professional conflicts that are associated with the conduct of clinical research.

  • Identify and apply the professional guidelines and codes of ethics that apply to the conduct of clinical research.

  • Describe the effect of cultural diversity and the need for cultural competency.

 

Product Development and Regulations in Clinical Research: 3 credits, upper division level

  • Audit and inspection processes as well as the clinical developmental process.

  • Clinical trial registries and requirements.

  • Elements of fraud and misconduct.

  • IRB / IEC reporting requirements and TRB / IEC role, composition, and purpose.

  • Protocol and protocol amendment submission and approval processes.

  • Regulatory and safety reporting requirements.

  • Significant milestones in the evaluation of efficacy and safety.

 

Scientific Concepts and Research Design: 3 credits, lower division level

  • Elements of scientific study protocols.

  • Elements of an investigational device.

  • Elements of and rationale for subject requirements.

  • Rationale for complying with a protocol.

  • Statistical principles.

  • Study design and characteristics of studies such as double-blind, crossover, and randomized.

  • Study objectives and outcomes.

  • Use of supplemental / rescue /comparator product in study design.

  • Treatment assessments.

 

Study and Site Management for Clinical Research: 4 credits, upper division level

  • Communication documentation requirements.

  • Contract budget negotiations and approval process.

  • Elements of a study budget.

  • Equipment and supplies used as well as equipment maintenance.

  • Investigational product characteristics, labeling, packaging, accountability, documentation, and shipment.

  • Non-compliance management.

  • Project timeline.

  • Purpose of and processes for protocol compliance.

  • Sample collection, shipment, and storage requirements.

  • Subject responsibilities for study participation, subject visit activities, and subject compliance assessment.

  • Vendor management.