Clinical Trials Management and Advanced Operations
Learn advanced clinical trial management, from protocol events to systematic reviews. Master regulatory compliance and evidence synthesis.
Learn advanced clinical trial management, from protocol events to systematic reviews. Master regulatory compliance and evidence synthesis.
This course cannot be purchased separately - to access the complete learning experience, graded assignments, and earn certificates, you'll need to enroll in the full Clinical Trials Operations Specialization program. You can audit this specific course for free to explore the content, which includes access to course materials and lectures. This allows you to learn at your own pace without any financial commitment.
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What you'll learn
Detect and respond to protocol events effectively
Recognize and address trial misconduct
Ensure participant safety and trial integrity
Develop and maintain proper study documentation
Conduct systematic reviews and meta-analyses
Skills you'll gain
This course includes:
4.2 Hours PreRecorded video
5 quizzes
Access on Mobile, Tablet, Desktop
FullTime access
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There are 5 modules in this course
This comprehensive course covers advanced aspects of clinical trials management, focusing on protocol events, regulatory compliance, and evidence synthesis. Students learn to detect and respond to protocol events, ensure participant safety, and maintain study integrity. The curriculum includes systematic review methods, meta-analysis techniques, and standardized documentation practices. Practical instruction on regulatory affairs, trial misconduct prevention, and research reproducibility prepares learners for professional roles in clinical research.
Protocol Events
Module 1 · 42 Hours to complete
Regulatory Affairs and Trial Misconduct
Module 2 · 51 Hours to complete
Standardization, Transparency, and Research Reproducibility
Module 3 · 46 Hours to complete
Evidence Synthesis: Introduction to Systematic Reviews and Meta-Analysis
Module 4 · 1 Hours to complete
Study Documents
Module 5 · 1 Hours to complete
Fee Structure
Instructors
Clinical Trials Expert and Associate Scientist at Johns Hopkins University
Dr. Ann-Margret Ervin is an Associate Scientist at Johns Hopkins University, with a focus on the design and conduct of randomized clinical trials, particularly in the field of ocular disease and visual impairment. Her research encompasses a wide range of topics, including age-related macular degeneration, cataracts, and diabetic retinopathy. Dr. Ervin serves as Co-Principal Investigator for several significant projects, including a multicenter observational study of Stargardt Disease and a clinical trial investigating the effects of lutein and zeaxanthin on ocular health. Additionally, she is engaged in research examining the ethical implications of federal regulations on institutional review boards (IRBs) and their impact on multicenter clinical trials.In her role at Johns Hopkins, Dr. Ervin also teaches courses on clinical trials management and quality assurance, contributing to the education of future public health professionals. Her extensive experience in clinical trial methodology and her commitment to improving research ethics make her a valuable asset to the field of epidemiology and public health.
Senior Research Program Manager and Clinical Trials Expert at Johns Hopkins University
Anne Shanklin Casper, MA, is a Senior Research Program Manager at Johns Hopkins University, specializing in clinical trials management and operations. With extensive experience in overseeing clinical research projects, she plays a crucial role in ensuring the successful execution of trials while adhering to regulatory standards and best practices. Her expertise encompasses various aspects of clinical trial management, including protocol development, participant recruitment, and data integrity. She is also an instructor for the course "Clinical Trials Management and Advanced Operations" on Coursera, where she shares her knowledge and skills with aspiring professionals in the field.In her role at Johns Hopkins, Casper collaborates with multidisciplinary teams to enhance the efficiency of clinical research processes. Her commitment to advancing clinical trial methodologies and her focus on training the next generation of researchers make her a valuable asset to the institution and the broader public health community.
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4.7 course rating
66 ratings
Frequently asked questions
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