Course Description

The online 10-Week CRA & CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC) for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or career change into clinical research, but haven’t decided which job track to pursue. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA and CRC.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Describe and discuss the investigational product development process, including FDA regulations, ICH guidelines, and Good Clinical Practice (GCP)
• Explain the roles and responsibilities of a CRA and CRC
• Describe the four types of monitoring visits, including the responsibilities of the CRA and CRC in preparation, activities, and follow-up
• Explain the Key Pre-Study Concepts: Role of the Principal Investigator, Site Selection, Clinical Trial Agreement and Budget Negotiation
• Discuss the role of the Institutional Review Board in clinical trials, define informed consent requirements, and discuss the informed consent process
• Discuss the study site initiation, interim monitoring activities, and data management
• Define safety definitions and reporting requirements for both drugs and devices
• Examine accountability for the investigational product and study closeout visits
• Discuss regulatory compliance and quality assurance as it relates to audits and inspections

Course Outline

• Module 1: Investigational Product Development, the FDA, and Good Clinical Practice Guidelines
• Module 2: Clinical Research Team: Roles and Responsibilities
• Module 3: The Principal Investigator, Site Selection, and Budget Negotiation
• Module 4: Clinical Study Protocol Elements
• Module 5: Institutional Review Boards, the Consent of Human Volunteers, and HIPAA
• Module 6: Study Monitoring, Data Management, and Study Initiation Visit
• Module 7: Safety Reporting: Definitions and Reporting Requirements
• Module 8: Accountability for the Test Article and Trial Termination Visits
• Module 9: Regulatory Compliance and Quality Assurance: Audits and Inspections
• Module 10: Managing Your Time and Preparing for the Interview

Who Should Attend

• Aspiring Clinical Research Associates and Clinical Research Coordinators (This course is also appropriate for Clinical Research Associates and Clinical Research Coordinators with less than six months of experience)
• College Students and New Graduates in a Scientific Field
• Nurses

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

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.

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

Susan Torchio, R.N., B.S.N.

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

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-002-L99-P. Released: 1/23.

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