Course Description

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC.

Learning Objectives

• Describe the investigational product development process
• Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practices (GCPs)
• Describe the roles and responsibilities of the Clinical Research Associate and the Clinical Research Coordinator before, during, and after a clinical trial
• Identify the requirements of the Investigator in supervising clinical research
• Discuss the role of an Institutional Review Board, its composition, and responsibilities in the clinical trial process
• Define the informed consent process, the elements of the informed consent document
• Describe an overview of the different types of Monitoring Visits, including preparation, activities, and monitoring visit follow-up
• Define source documents and Case Report Forms (CRFs) in relation to CRF completion and source document verification
• Describe definitions related to safety management, identification of adverse events, and reporting requirements
• Describe the difference between a sponsor audit and an FDA inspection and preparation

Who Should Attend

• Aspiring Clinical Research Coordinators and Nurses
• Aspiring Clinical Research Associates – In-house or Field-based
• College Students and New Graduates in a Scientific Field
• NOTE: This course is also appropriate for CRAs or CRCs with less than six months experience

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Sonja Cooper, Ph.D., M.B.A.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• Introduction to Clinical Research
• Clinical Research Team: Roles & Responsibilities
• Investigational Product (IP) Development  
• Good Clinical Practice: FDA Regulations, FDA Guidance, and ICH GCP E6 Guideline

Day Two

• The Clinical Study Protocol and Study Feasibility
• The Principal Investigator, Site Selection, and Study Initiation  
• Institutional Review Board, the Consent of Human Volunteers, and HIPAA  
• Safety Reporting: Definitions & Reporting Requirements

Day Three

• IP Accountability, Essential Documents, and Routine Monitoring Visits
• Source Document Verification, Data Management, and the Trial Close-out Visit  
• Interactive Exercises I and II: CRF completion and monitoring simulation exercises
• Regulatory Compliance & Quality Assurance: Audits & Inspections

Interactive Activities

• Case Study Reviews – Adverse Events, Protocol Modifications, Study Feasibility, Informed Consent and Monitoring Visit Scenarios
• Site Selection, IP Accountability, Source Document Verification and Case Report Form Exercises

Registration Fees

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 22.5 hours (2.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-004-L04-P. Released: 3/22. 

                Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.