Clinical research coordinators help Principal Investigators initiate and manage their research protocols. Programs with clinical research courses are available at the certificate, associate's and bachelor's level. Some certificate programs require that students have a bachelor's degree before applying.
Here are some common topics covered in clinical research coordinator courses:
- Good Clinical Practice
- Research Ethics
- Internal Review Boards
- Statistical Analysis
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List of Common Courses
Medical Terminology for Clinical Research Coordinators Course
Students in this introductory course learn the vocabulary needed for clinical research, practicing the use of medical word roots and their prefixes and suffixes to create terms and analyze word meanings. Emphasis is placed on terminology related to the human body and its functions, anatomy and diseases. This is typically found in certificate and associate's degree programs.
Survey of Clinical Research Course
This introductory class thoroughly examines the process of clinical research, from history and development to how research trials are conducted today. Biomedical, health and biotechnical venues are considered, with a strong focus on the ethics and regulations regarding patient safety. Students learn the basics of project design and implementation. The administrative aspects of research, such as funding acquisition and product approvals, are also discussed.
Ethics in Clinical Research Course
Informed consent, integrity, moral reasoning, compassion and self-determination are among the fundamental considerations in ethical research; they are covered in length in this course. Students look at how history has inspired today's bioethical standards for adult, child and animal clinical trials, in addition to confronting concerns about false research data, plagiarism and disclosure of research errors.
Clinical Research Laws and Regulations Course
An abundance of regulatory agencies exists to monitor clinical research in the U.S. and internationally. This class provides a survey of these agencies, including their organizational structures and functions. Topics also delve into the development of guidelines and laws covering biological substances, drugs and other products.
Data Management for Clinical Research Coordinators Course
Meaningful data is at the heart of clinical research, and this course provides thorough instruction in how to gather, record, store and interpret research findings. Students learn to design a data structure, create study charts and use relational databases. Additional projects focus on data collection, adverse event reporting, audit preparation and publication of results. Since patient confidentiality is paramount, data security is also an important topic.