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 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 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
- 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
- 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!”
The course will be led by one of the following
instructors:
Janet Ellen Holwell,
C.C.R.C., C.C.R.A.
Angie Maurer, R.N., B.S.N., M.B.A.
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#:
0778-0000-17-014-L01-P. Released: 3/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
