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.
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.
- Describe and discuss the investigational product
development process, including FDA regulations, ICH guidelines, and Good
Clinical Practice (GCP)
- 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
- Explain the Key Pre-Study Concepts:
Role of the Principal Investigator, Site Selection, Clinical Trial
Agreement and Budget Negotiation
- Discuss the role of the Institutional
Review Board in clinical trials, define informed consent requirements, and
discuss the informed consent process
- Discuss the study site initiation,
interim monitoring activities, and data management
- Define safety definitions and
reporting requirements for both drugs and devices
- Examine accountability for the
investigational product and study closeout visits
- Discuss regulatory compliance and
quality assurance as it relates to audits and inspections
- 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
- 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
- Nurses
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!”
The course will be led by one of the following
instructors:
Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.
Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
Elizabeth Ronk Nelson, M.P.H.
Susan Torchio, R.N., B.S.N.
Click here for complete trainer
biographies
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.
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#:
0778-0000-20-019-L01-P. Released: 2/20.
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 competed: 30 Approval Number: 7914-6/19-21
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.