The online 10-Week Clinical Research Associate (CRA) “on-boarding” training course is appropriate for individuals who have less than two years experience as a Clinical Research Associate. The course 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 both drug/biologic and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both US and global audiences. Core Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.
This course is built on Barnett’s deep in-person CRA training experience and 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 the peace of mind knowing that you are training your new hires to the highest industry standards.
The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.
Before the class starts, you will receive your class books and reference guides. During the live Interactive Web Seminar, you will be able to ask questions and provide feedback. You will be required to pass both a mid-term and a final in order to receive accreditation CEUs. Upon completion, training certificates will be provided to all participants and accreditation CEUs will be requested.
- Module 1: Drug Development Process, Good Clinical Practice (GCP) and Clinical Research Team Roles and Responsibilities
- Module 2: IRB, Clinical Study Protocol Elements and Amendments
- Module 3: Informed Consent
- Module 4: Investigational Product Accountability
- Module 5: Safety Definitions and Reporting Requirements
- Module 6: Source Document Verification
- Module 7: Monitoring the Study
- Module 8 and Module 9: Monitoring Visit Reports and Contact Reports
- Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections
- Clinical Research Associates with less than two years experience – In-house or Field-based
- Those currently working in the industry in a different role and 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.
This course will be taught by one of the following instructors:
Karen L. Gilbert, B.S., C.C.R.A.
Lily Romero, P.A., C.C.R.C.
Jackie Stader, C.O.T, C.C.R.C.
Click here for complete trainer biographies
10 weeks for 3 hours each week. Friday mornings, 8:30 – 11:30 a.m. Eastern
$1,695 by Early Bird Deadline noted in Upcoming Courses section above
$1,895 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.
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 pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-033-L01-P. Released: 3/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.