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. Upon completion, Barnett will provide resume assistance so that you can position yourself for entry into this market.
The resources required to take this online course are 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 comprehensive course materials. 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.
- Describe and discuss the investigational product development process, including FDA regulations, ICH guidelines, and Good Clinical Practices (GCPs)
- 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
- Discuss the role of the Institutional Review Board in clinical trials, define informed consent requirements, and discuss the informed consent process
- Define safety definitions and reporting requirements for both drugs and devices
- Discuss regulatory compliance and quality assurance as it relates to audits and inspection
- 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 and Statistical Considerations
- 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
- 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
NOTE: This course is for individual registrants only and does not allow for group training.
What previous students have said ...
“Many times over the last 10 weeks, I’ve been able to apply the information directly to something I was working on at my job. I appreciated being able to see the importance of the quality of the work I do. We work with many different CROs and sponsors. It was extremely helpful seeing the clinical trial industry from their perspective.”
“I thought it was fantastic and it did help me land my job – a CRA I. My satisfaction with the class was high because there was interaction AND online – a tough combo to find.”
“I am a CRC and am running four studies now. The class was such a great class to start with and I am using what I learned daily. I am very happy to be in research.”
“I'm a technical trainer for a large clinical trials division and my goal in taking this course was to better understand the role played by a CRA. This course has definitely done that for me and I can see myself applying what I have learned to my trainings. The presenter has a lot of real world knowledge and experience which she constantly applied to the course. I couldn't ask for a better speaker/trainer. Very easy to navigate and great use of technology. On a scale of 1 to 10......12!”
This course will be taught by one of the following instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Janet Ellen Holwell, C.C.R.C., C.C.R.A.
Susan Torchio, R.N., B.S.N.
Click here for complete trainer biographies
10 weeks for 3 hours each week.
Wednesday nights, 6:00 – 9:00 p.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 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#: 0778-0000-14-053-L01-P. Released: 10/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.