Course Description

This newly updated online 10-Week program provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course is built on Barnett’s deep in-person CRA training experience and is designed to engage participants actively, making the learning experience truly dynamic. Here’s what participants can expect from this revamped, highly interactive training program:

• Enhanced Skills Development: Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, in class breakout sessions, interactive web-based knowledge applications, information and support.
• Experts in the Field: Instructor-led weekly classes by an experienced subject matter expert who is passionate about creating interactive learning environments, ensuring participants get the most out of every session.
• Technology Integration: Delivered through Barnett’s Learning Management System (LMS) this course leverages cutting-edge technology to facilitate an interactive learning experience, making complex concepts easier to grasp.
• Application-based Homework Assignments and Final Project: Designed to help gauge progress and allow participants to apply their knowledge in a practical context, fostering a deeper understanding of the material.

The course is designed for “on-boarding” of individual new hires or entire teams. If you are a CRA manager or human resources professional responsible for the orientation and training of one new CRA or 100, this course provides a convenient, cost-effective, comprehensive, and interactive training method. You’ll have peace of mind knowing that you are training your new hires to the highest industry standards.

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 the application and intention of GCPs
• Differentiate the roles of the Sponsor and Investigator
• Review the drug and device development process
• Discuss the roles and responsibilities of a CRA within clinical research drug and device trials in relation to other roles within an organization
• Discuss protocol design and areas of protocol focus for CRAs
• Discuss the role of Institutional Review Boards (IRBs)/Ethics Committees (ECs)
• Evaluate the Informed Consent Document, process, and monitoring expectations
• Review key essential documents and the CRAs responsibilities in reviewing the Site Master File (SMF) and document collection
• Apply skills in monitoring essential documents and Investigational Product Accountability
• Define Adverse Event monitoring expectations and reporting
• Identify and apply requirements for types of monitoring visits (qualification, initiation, routine monitoring, remote monitoring, closeout visits)
• Discuss key CRA responsibilities during monitoring visits (on-site and remote) including source document verification and source document review
• Apply monitoring skills
• Discuss writing monitoring reports, queries, and visit follow up expectations
• Discuss elements of a study audit, preparation, and common findings

Course Outline

• Module 1: Applications of GCPs in Drug and Device Development Process and Sponsor and Investigator Responsibilities
• Module 2: Drug and Device Development, Roles and Responsibilities of CRAs, and Navigating Protocols
• Module 3: Role of IRBs/ECs and Informed Consents
• Module 4: Essential Documents and Investigational Product Accountability
• Module 5:Safety Definitions and Reporting Requirements
• Module 6: Monitoring Visit Types and Monitoring Expectations
• Module 7: Source Document Verification
• Module 8: Monitoring Visit Reports, Follow-Up Letters, and Contact Reports
• Module 9: Regulatory Compliance and Quality Assurance: Audits and Inspections
• Module 10: Final Project and Course Review

Who Should Attend

• CRAs with less than two years of experience – in-house or remote
• Those currently working in the industry in a different role seeking to change roles
• The course is also ideal for “on-boarding” of individual new hires or entire teams (individual registrations required)

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

What previous students have said ...

“The CRA course increased my awareness of the importance of developing strategies and risk-based approaches to monitoring. The breadth of knowledge and experience of the trainers was impressive. The overview of quality systems and regulatory expectations will surely have a place in my daily monitoring activities.”

“This program opened the door for me to really understand what a CRA does and how to document everything. It gave me a true guideline as I manage expectations of all parties and what to look out for during visits, as well as how to document findings in a responsible, accurate way. Thank you so much.”

“I have been given a solid framework on how to approach future studies from site selection, protocol development, and inclusion/exclusion importance to regulatory considerations (when to report what to whom). I plan to make use of all the monitoring tools provided to achieve success and utilize EDC for ease of CRF collection. When in doubt, I will always refer back to modules for guidance. Great course, thanks!”

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.

Elizabeth Ronk Nelson, M.P.H.

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#: 0778-0000-23-003-L99-P. Released: 3/23.

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