Clinical Research Operations

The course provided the knowledge and operational skills necessary to develop, implement, and manage a clinical trial including budget and contract negotiations, clinical trial site evaluation and selection, marketing and advertising for recruitment, and project management, audits and reporting.

  • Evaluate the impact of study phase and design as it impacts clinical trial operations and compliance with Good Clinical Practice Guidelines.
  • Appraise the methods for selecting and evaluating potential clinical trial sites
    Compare and contrast the roles and responsibilities of the clinical research site and sponsor/monitor.
  • Analyze standard research industry contracts including form, function, and issue. 
  • Generate a plan for clinical trial enrollment, recruitment, and retention of study.
  • Compose an operational implementation timeline including procedures for FDA audits and reporting, cash flow analysis, and study closure procedures.
  • Communicate the plans to bring an investigative site/PI into compliance with FDA.
  • Synthesize the key components from a clinical trial for post-study reporting and dissemination of clinical trial results.

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