Clinical Trials Management Certificate
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
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