Course Description

The Clinical Research Coordinator (CRC) has a vital role in the conduct of a clinical trial and is a key liaison between the investigator, subject, IRB, and sponsor. The online 10-Week Clinical Research Coordinator (CRC) On-Boarding Program will provide a comprehensive introduction to clinical research and the job functions of the CRC for both drug/biologic and device trials. This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials.

Case studies and industry best practices will be presented to underscore how the learning objectives apply directly to the responsibilities of the 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

• Understand the roles and responsibilities of the Clinical Research Coordinator
• Prepare for what a pharmaceutical or device sponsor is looking for in a research site during a pre-study evaluation or site selection visit
• Understand the requirements for source documentation, case report forms, study tool development, and standard operating procedures (SOPs)
• Define informed consent requirements and learn the process of conducting informed consent
• Define safety reporting: Definitions and reporting requirements
• Discuss regulatory compliance and quality assurance as it relates to audits and inspections

Course Outline

• Module 1: Introduction to Clinical Research, Investigational Product Development: Drug and Device, Regulatory Oversight, and Good Clinical Practice Guidelines
• Module 2: The Clinical Research Team: Roles and Responsibilities
• Module 3: The Principal Investigator and Site Selection
• Module 4: Clinical Study Protocol Breakdown and Feasibility Evaluation
• Module 5: Source Documentation, Case-Report Forms, Study Tool Development, and Standard Operating Procedures
• Module 6: Informed Consent Requirements and Process
• Module 7: Study Initiation, Start-up, and Ongoing Management Activities and Sponsor Expectations
• Module 8: Safety Reporting: Definitions and Reporting Requirements
• Module 9: Accountability for the Test Article and the Trial Termination Visit
• Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspection

Who Should Attend

• Aspiring CRCs (This course is also appropriate for CRCs with less than six months of experience)
• College Students and New Graduates in a Scientific Field
• Nurses interested in developing skills in clinical research

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

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

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#: 0778-0000-23-004-L99-P. Released: 3/23.   

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