10-Week Clinical Research Associate (CRA) On-Boarding Program

Course Description

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. 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 drug, biologic, and device trials. 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.

The 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 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.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. 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 drug development process, the importance of Good Clinical Practice (GCP), and the roles and responsibilities of the research team
• Define the regulatory requirements, explain the differences between ICH GCP E6 and FDA requirements, and describe the elements of a protocol
• Outline required elements of the informed consent
• Identify the investigational product accountability requirements and impact of the reconciliation process on the study
• Define the safety definitions and comprehend the safety reporting requirements
• Prepare for and perform source document verification
• Perform the steps involved in monitoring the investigational site: Pre-visit, during the visit, and post-visit
• Create cohesive, well-written protocol deviations and action items, and accurately complete the monitoring visit report and site follow-up letter
• Define the impact of quality assurance and audits in clinical research

Course Outline

• Module 1: Investigational Product Development Process: Drug and Medical Device, 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, Follow-Up Letters, and Contact Reports
• Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections

Who Should Attend

• Clinical Research Associates with less than two years of experience – in-house or field-based
• 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.

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

The New Jersey State Nurses Association is accredited by the ANCC Commission on Accreditation of the American Nurses Association as an approver of continuing education for nursing. As an accredited body, NJSNA has approved this program for: Contact hours completed: 30  Approval Number: 7973-8/21-23.

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