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Clinical Trials Management Certificate

Michelle Frascella

The 14-week, self-paced, online Clinical Trials Management Certificate program consists of 20 contact hours of instruction. Participants acquire the following key competencies during this 14-week program: • Defining the steps in the development, implementation and integration processes of clinical research, including the roles and responsibilities of those conducting and administering these processes. • Explaining and comparing human clinical testing models with animal testing models. • Describing the processes involved in conducting safe, thorough and reliable clinical trials: monitoring visits, obtaining valid and reliable data, emerging markets, and reporting of safety concerns. • Recognizing the steps necessary for the completion and evaluation of clinical trials processes • Effectively reporting the outcome of clinical trials, including unbiased reporting to potential consumers regarding the results, limitations and availability of the new product. • Reviewing case studies for ethical and safety violations in clinical trials and their effect on new product development. To earn the Clinical Trials Management Certificate, each participant must: • Complete and pass two module quizzes and a comprehensive final exam. These assignments cover the development, integration and implementation processes of clinical trials. • Complete each program module with a passing grade and earn a “C” or above as the course grade.

Skills / Knowledge

  • Clinical Research
  • Clinical Trials
  • Association of Clinical Research Professionals (ACRP)
  • Product Development
  • Regulatory Compliance
  • Investigative Site
  • NDA (New Drug Application)
  • Clinical Compliance
  • Data Reporting & Management
  • Site Management
  • Clinical Site Monitoring
  • Clinical Marketing

Issued on

December 11, 2024

Expires on

Does not expire
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  • Bristol Myers Squibb
  • Merck
  • Albany Medical Center
  • Thermo Fisher Scientific
  • IQVIA