Short Term Program in Clinical
Research Nursing

Overview (50 HOURS)

Clinical Research Nurse is an exclusive program designed for students and those working professionals in the nursing field who seek to enhance their career. The Certificate in Clinical Research Nurse provides hands-on-access to Oracle tools, Data Management and Advanced Trial Management functions.

Syllabus

  • Steps for Drug Development Process
  • Phases and Functions of Clinical Trials
  • Ethical Evolution, Belmont Report
  • Evolution of FDA and ICH guidelines
  • Good Clinical Practice, FDA regulations
  • Additional Rules for protection of vulnerable population and HIPAA
  • Roles and responsibilities of Sponsor, investigator and IRB
  • Understand Investigator’s Brochure
  • Protocol Types and Designs
  • Informed Consent Document
  • Site Selection Process
  • Site Initiation Process
  • Screening, Recruitment and Retention
  • Protocol Compliance and Deviation
  • Case Report Forms
  • AE/SAE Forms and Reporting
  • IMP-Drug Inventory Management
  • Site Regulatory Document Management
  • Site Monitoring, Audit functions
  • Scientific integrity, Fraud and Misconduct
  • Site Closeout, Drug Return, Records Function
  • Final Reports, FDA Inspections
  • e-Clinical Trials, Data management
  • Data Query Resolution
  • Data integrity and ICH guidelines
  • Leadership Functions at Trial Site
  • Evaluating Evidence Based Interaction
  • Compliance for Risk Based Monitoring
  • Introduction to Clinical Data Management and Oracle Clinical
  • Oracle Clinical Data Entry
  • Electronic Data Capture (EDC) is the method of data collection that allows the data to be entered by the Investigator directly into the Oracle Clinical database.
  • The Oracle RDC Onsite software is an EDC tool used in conjunction with Oracle Clinical.
  • In this module, you will understand the process of entry of data using the Oracle RDC onsite software and manage discrepancies within it.

Course Date

Starting soon

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50 Days Program

8 weeks
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Campus Visit

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