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Official Course
Description: MCCCD Approval: 12-11-07 |
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CRC290
2008 Spring – 2010 Summer
II |
LEC 3.0 Credit(s) 3.0 Period(s) 3.0 Load Occ |
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Introduction
to Clinical Research Associate |
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Introduction
to the Clinical Research Associate (CRA) profession as an advanced career
path for clinical research coordinators. Topics include CRA role, career
development, study development process, monitoring, training and oversight,
and regulations. Effective analysis, synthesis, and evaluation of topics
through written discourse. Prerequisites: (Completion of the
certificate of completion in Clinical Research Coordinating) or (two [2]
years of clinical research work experience) or (certification as a clinical
research coordinator) or (Bachelor [or higher] degree in life or health
sciences) or permission of department or division. |
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Go to Competencies Go to Outline
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MCCCD
Official Course Competencies: |
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CRC290 2008
Spring – 2010 Summer II |
Introduction to Clinical Research Associate |
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1.
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Compare and contrast the role and responsibilities of the
Clinical Research Associate (CRA) to those of the Clinical Research
Coordinator (CRC) and as liaison between the site and the sponsor. (I) |
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2.
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Prepare career plan for obtaining initial CRA position and
career advancement. (I, VI) |
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3.
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Describe the typical sponsor/contract research
organization (CRO)/site management organization (SMO) hierarchy. (II) |
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4.
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Design a study project timeline. (II) |
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5.
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Outline and detail the study development process. (II) |
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6.
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Compare and contrast drug/biologic and device research.
(II, V) |
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7.
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Apply Good Clinical Practice (GCP) guidelines and
regulatory processes to the CRA role. (III, V) |
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8.
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Discuss the rationale for site setup and maintenance of a
research site. (III) |
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9.
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Explain the conduct of an audit. (III) |
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10.
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Present a standard site training module. (IV) |
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11.
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Write a Standard Operating Procedure. (IV) |
Go to Description Go to top of
Competencies
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MCCCD
Official Course Outline: |
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CRC290 2008
Spring – 2010 Summer II |
Introduction to Clinical Research Associate |
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I. CRA Role A. Job Descriptions B. Environment - Sponsor
vs. CRO C. Technology D. Responsibilities E. CRA Role vs. CRC Role F. Phase I versus other
Phase trial responsibilities II. Study Development
Process A. Drug Development Process
overview B. Sponsor/site/CRO
interaction C. Contract Research
Organizations vs. Site Management Organizations D. Organizational Charts E. Standard Study Designs
and Statistical Analyses III. Monitoring A. Overview of process B. Typical visits and
purpose C. Case Report Forms D. Internal vs. External
Audits E. Regulatory Compliance
Checks F. Drug Accountability,
special security substances (SSS) requirements IV. Training and Site
Oversight A. Regulations B. Technology C. Role of Principal
Investigator - Regulatory Personnel, study coordinator (SC) D. Standard Operating
Procedures - Site and Sponsor Level E. Therapeutic Differences V. Regulations A. Sponsor Responsibilities
B. Investigational New Drug
(IND) vs. Investigational Device Exemption (IDE) C. Investigators VI. Career Development A. Introduction to the CRA
Job world B. Networking C. CRA I, II and III.
Senior and Lead level positions D. Internal CRAs vs.
Regional CRAs E. Trends |
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