This specialization is designed for individuals and teams that will be running or interacting with clinical trials. In four courses, learners will develop insights and build the skills they need to design, manage, and monitor clinical trials as well as analyze, document, and communicate the results. Learners will also learn best practices regarding ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills of the specialization will lay the foundation for a successful career in the field.
Clinical Trials Operations Specialization
Clinical Trials Operations Specialization
Design and Conduct Successful Clinical Trials. Build skills for conducting successful and impactful clinical trials.
Instructors: David M. Shade, JD
Included with 
Get in-depth knowledge of a subject
(513 reviews)
Beginner level
Recommended experience
4 months at 3 hours a week
Flexible schedule
Earn a career credential
Share your expertise with employers
Get in-depth knowledge of a subject
(513 reviews)
Beginner level
Recommended experience
4 months at 3 hours a week
Flexible schedule
Earn a career credential
Share your expertise with employers
What you'll learn
Design and implement clinical trials
Collect, manage, and analyze data
Conduct trial monitoring and quality assurance
Recruit and retain clinical trial particpants
Overview
Skills you'll gain
- Informed Consent
- Clinical Research
- Sample Size Determination
- Data Integrity
- Quality Assurance
- Data Management
- Case Report Forms
- Data Entry
- Institutional Review Board (IRB)
- Clinical Documentation
- Clinical Data Management
- Good Clinical Practices (GCP)
- Clinical Research Ethics
- Data Quality
- Clinical Trials
- Data Cleansing
- Data Collection
- Regulatory Compliance
- Statistical Reporting
Tools you'll learn
What’s included
Shareable certificate
Add to your LinkedIn profile
Taught in English
21 practice exercises
Advance your subject-matter expertise
- Learn in-demand skills from university and industry experts
- Master a subject or tool with hands-on projects
- Develop a deep understanding of key concepts
- Earn a career certificate from Johns Hopkins University
Specialization - 4 course series
What you'll learn
Evaluate and select clinical trial designs
Implement bias control measures
Randomize participants into groups
Define clinical trial outcomes
Skills you'll gain
Clinical Trials, Clinical Research Ethics, Clinical Research, Informed Consent, Good Clinical Practices (GCP), Healthcare Ethics, Regulatory Compliance, Biostatistics, and Science and Research
What you'll learn
Collect and manage clinical trials data
Assemble and share clinical trials data
Conduct statistical performance monitoring
Perform quality assurance for clinical trials
Skills you'll gain
Quality Assurance, Data Management, Data Quality, Data Sharing, Data Security, Data Cleansing, Data Entry, Data Collection, Continuous Monitoring, Statistical Analysis, Clinical Data Management, Case Report Forms, Clinical Trial Management Systems, Clinical Trials, Patient Treatment, and Data Integrity
What you'll learn
Detect and respond to protocol events
Recognize and respond to misconduct
Safeguard participant safety and trial integrity
Develop and maintain study documents
Skills you'll gain
Clinical Research Ethics, Good Clinical Practices (GCP), Institutional Review Board (IRB), Clinical Documentation, Clinical Trials, Scientific Methods, Clinical Research, Clinical Trial Management Systems, Record Keeping, and Regulatory Compliance
What you'll learn
Calculate clinical trial sample size
Monitor clinical trial performance
Analyze results from clinical trials
Communicate results from clinical trials
Skills you'll gain
Bayesian Statistics, Sample Size Determination, Data Presentation, Statistical Methods, Advanced Analytics, Statistical Reporting, Data Analysis, Clinical Research, Communication, Statistical Analysis, Clinical Trials, and Patient Safety
Earn a career certificate
Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.
Instructors
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Frequently asked questions
It typically takes about four months to complete this specialization, but learners are free to work at their own pace.
We recommend that learners have some familiarity with basic scientific, statistical, and management concepts.
The sequence provided is optimal, but not required.
More questions
Financial aid available,