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Standard Data
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Course Title:
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The
Clinical Research Professional
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Subject Code:
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BSC
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Course Number:
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270
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Course Type:
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Newly
Developed (2009)
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Offered Online:
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Y
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Course Description:
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A
course to assist students to harmonize academic and practical aspects of
clinical research. Activities include a capstone project to assess student
understanding of the role of the clinical research professional in human
trials.
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Class Hours:
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3
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Demo Lab Hours:
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0
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Pract. Lab/O.B.I.Hours:
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0
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Credit Hours:
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3
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Prerequisites
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Corequisites
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Course Guide
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Competency
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After Completion the student will:
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Class
Hours
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Demo Lab
Hours
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P.Lab/
O.B.I
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Duties and responsibilities
of a clinical research professional in a typical research study
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10
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0
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0
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Scope
of responsibility
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List the primary functions
that CRPs perform in the course of a typical study, from start-up
until termination.
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Nature
of duties
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Define the purposes of a
CRP in a trial, including to the principal investigator,
Institutional Review Board, FDA, sponsor, and the subjects.
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Ethical
responsibilities
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Describe the ethical and
moral obligations of the CRP to the subject and to the study, based
on the Historical Documents and BSC 243.
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Daily
routine
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List the potential tasks
executed during the typical day of a CRP in an active trial.
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Range of career potentials
available in clinical research
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10
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0
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0
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Clinical
Research Coordinator
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Describe the scope of
practice and the routine duties of a Clinical Research Coordinator.
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Clinical
Research Associate
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Describe the scope of
practice and the routine duties of a Clinical Research Associate.
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Clinical
Research Data Manager
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Describe the scope of
practice and the routine duties of a Clinical Research Data Manager.
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Regulatory
Specialist
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Describe the scope of
practice and the routine duties of a Clinical Research Regulatory
Specialist.
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Clinical
Research Management
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Describe the opportunities
to progress to managerial and leadership roles in clinical research.
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Industrial
Opportunities
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Describe the scope of
opportunities for placement into pharmaceutical companies,
governmental regulatory agencies, and Contract Research
Organizations.
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Potential changes in the
future of clinical research trials
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10
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0
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0
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Changes
in regulatory oversight
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Projected changes in DHHS,
FDA, and PHS that will impact the performance of clinical trials.
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Changes
in fiscal factors
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Changes in funding through
government, sponsor, institutions, or insurance that may impact trial
performance.
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Changes
in medication and device design
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Availability of new
classes of medications or devices, or new types of medical
technologies that may substantively change how trials are performed.
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The
role of the Clinical Research Professional
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How the changes indicated
above are likely to alter the duties and responsibilities of the
Clinical Researcher, and steps she/he may take to remain competitive
in the field.
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