This
beginner course provides an excellent introduction to clinical research and the
job responsibilities of Clinical Research Associates (CRAs) and Clinical
Research Coordinators (CRCs). It explores topics relevant to those considering
a career as an entry-level CRA or CRC.
- Describe the investigational product development
process
- Review FDA regulations and the ICH
GCP E6 Guideline for Good Clinical Practices (GCPs)
- Describe the roles and responsibilities
of the Clinical Research Associate and the Clinical Research Coordinator
before, during, and after a clinical trial
- Identify the requirements of the
Investigator in supervising clinical research
- Discuss the role of an Institutional
Review Board, its composition, and responsibilities in the clinical trial
process
- Define the informed consent process,
the elements of the informed consent document
- Describe an overview of the
different types of Monitoring Visits, including preparation, activities, and
monitoring visit follow-up
- Define source documents and Case
Report Forms (CRFs) in relation to CRF completion and source document
verification
- Describe definitions related to
safety management, identification of adverse events, and reporting
requirements
- Describe the difference between a
sponsor audit and an FDA inspection and preparation
- Aspiring Clinical Research Coordinators and
Nurses
- Aspiring Clinical Research
Associates – In-house or Field-based
- College Students and New Graduates
in a Scientific Field
- NOTE: This course is also
appropriate for CRAs or CRCs with less than six months experience
The course will be led by one of the following
instructors:
Nikki
Christison, B.S., C.C.R.A., T.I.A.C.R.
Gary B. Freeman, M.S.
Marla Hoelle, R.N., B.S.N.,
C.C.R.A., P.M.P.
Lily Romero, P.A., C.C.R.C.
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biographies
Day One: 8:30 a.m. – 5:00 p.m.
- Introduction to Clinical Research
- Clinical Research Team: Roles & Responsibilities
- Investigational Product (IP) Development
- Good Clinical Practice: FDA Regulations, FDA Guidance, and ICH GCP E6 Guideline
Day
Two: 8:30 a.m. – 5:00 p.m.
- The Clinical Study Protocol and Study Feasibility
- The Principal Investigator, Site Selection, and Study Initiation
- Institutional Review Board, the Consent of Human Volunteers, and
HIPAA
- Safety Reporting: Definitions & Reporting Requirements
Day
Three: 8:30 a.m. – 5:00 p.m.
- IP Accountability, Essential Documents, and Routine Monitoring
Visits
- Source Document Verification, Data Management, and the Trial
Close-out Visit
- Interactive Exercises I and II: CRF completion and monitoring simulation exercises
- Regulatory Compliance & Quality Assurance: Audits & Inspections
- Case Study Reviews – Adverse Events, Protocol
Modifications, Study Feasibility, Informed Consent and Monitoring Visit
Scenarios
- Site Selection, IP Accountability,
Source Document Verification and Case Report Form Exercises
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information
Registration
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
cancellation policy
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 22.5 hours (2.25 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-002-L01-P.
Released: 2/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
