At a Glance
- Open Enrollment
- 8 weeks
Gain an overview of the principles and practice of clinical research from a global perspective.
The University of Chicago’s eight-week Global Clinical Research course will provide you with a complete overview of the clinical trial process, from study start-up to trial close-out. Upon completing the course, students will be able to apply their new knowledge and skills to thrive in a highly controlled and regulated work environment.
This course is designed for healthcare, medical, and research professionals interested in starting or advancing their clinical research careers. A background in life science is preferred.
The trial area of the clinical research field is growing rapidly. Clinical trials are an essential part of making advances in diagnosing, treating, and preventing diseases and medical conditions. Demand for professionals equipped with the right clinical trial-related skills is soaring. Learn the processes and global regulatory procedures necessary to bring a drug to market.
After completing the course, you will be able to:
- Understand key terms and concepts of clinical research
- Describe core ethical principles that ensure that the rights and safety of human subjects are protected
- Understand the core principles and practices of clinical trials from a global perspective
- Define the ethical principles that guide the informed consent document and process
- Determine key factors that trigger a protocol amendment
- Apply new knowledge and skills to thrive in a highly controlled and regulated work environment
Clinical Research curriculum
You will learn to:
- Understand the clinical trial process from study start-up to trial close-out
- Explain the critical historical events that led to the globalized standardization of research conducted worldwide
- Describe core ethical principles of clinical research to ensure that the rights and safety of human subjects are protected
- Define the purpose of a clinical trial and develop standards for data collection and data quality to ensure data integrity in a clinical trial
- Understand the key terms, concepts, and acronyms associated with clinical research so that you can effectively communicate with key stakeholders in the industry
- Eight weeks in length
- Weekly, self-paced interactive learning modules and assignments are time-sensitive and should be completed by the set deadlines
- Synchronous sessions and live question and answer sessions
- Mentors will provide continuous support and encourage a dynamic and positive learning environment
Weekly course schedule
Explore clinical research and the current landscape of the industry, the ethical framework that guides the conduct of clinical research, the historical events and importance of Good Clinical Practice (GCP) in clinical research conducted around the world, how we protect the rights and safety of human subjects, and the need for globalized standards in clinical research.
Learn about the overall goals and types of clinical trials, the different phases of a clinical trial (Phase I, II, III, and IV trials), and ethical considerations in the design and execution of international clinical trials.
Learn to assess characteristics of a good research question, examine the essential elements and significance of a clinical trial protocol, and determine key factors that trigger a protocol amendment.
Explore the ethical principles that guide the informed consent document and process, essential elements that should be included in both the informed consent discussion and written informed consent, and challenges in the informed consent process.
Learn about the roles and responsibilities of clinical trial investigators, clinical trial sponsors, and Contract Research Organizations (CROs); key steps in planning and activating a clinical trial; and the role of monitoring to ensure that a trial complies with international regulations, standards, and guidelines.
Examine the roles and responsibilities of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) concerning human subject research; the role of Data Safety Monitoring Boards (DSMBs) and the regulations that guide them, as well as a real-world example of the role the DSMB plays in clinical trial oversight.
Learn about the importance of data collection and setting data quality standards for clinical research, developing strategies to ensure high-quality data, and analyzing critical data points and risk indicators.
Visualize the overall clinical trial timeline from start to finish and examine the importance of study close-out and results reporting.
Meet your instructor
Our course instructor has extensive experience in clinical research operations and oversight, which she is ready to share with you.
The global clinical trials market—currently valued at over 44 billion dollars—is expected to grow at a CAGR of 5.1% over the next seven years. In this thriving field, key drivers like the globalization of clinical trials and new, personalized treatments continue to impact market growth, while demand for skilled professionals widens the job market. The need for clinical trials professionals will continue to outpace that for similar roles.
Potential job titles for Global Clinical Research professionals
- Clinical Operations Director
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Manager
- Clinical Trial Assistant
- Clinical Trial Associate
- Data Manager
- Drug Safety Associate
- Research Nurse