Johns Hopkins University
Clinical Trials Operations Specialization
Johns Hopkins University

Clinical Trials Operations Specialization

Design and Conduct Successful Clinical Trials. Build skills for conducting successful and impactful clinical trials.

David M. Shade, JD
Elizabeth A. Sugar, PhD
Sheriza Baksh, PhD

Instructors: David M. Shade, JD

Included with Coursera Plus

Get in-depth knowledge of a subject
4.7

(510 reviews)

Beginner level

Recommended experience

16 weeks to complete
at 3 hours a week
Flexible schedule
Learn at your own pace
Get in-depth knowledge of a subject
4.7

(510 reviews)

Beginner level

Recommended experience

16 weeks to complete
at 3 hours a week
Flexible schedule
Learn at your own pace

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

Details to know

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Taught in English
21 practice exercises

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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, Informed Consent, Clinical Research Ethics, Regulatory Compliance, Good Clinical Practices (GCP), Science and Research, Biostatistics, and Healthcare Ethics

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

Data Management, Quality Assurance, Data Cleansing, Data Sharing, Data Security, Data Quality, Data Collection, Clinical Trials, Clinical Trial Management Systems, Statistical Analysis, Clinical Data Management, Continuous Monitoring, Case Report Forms, Data Integrity, Data Entry, and Patient Treatment

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 Trials, Clinical Research Ethics, Good Clinical Practices (GCP), Clinical Documentation, Institutional Review Board (IRB), Regulatory Compliance, Clinical Trial Management Systems, Record Keeping, Clinical Research, and Scientific Methods

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, Statistical Methods, Data Presentation, Advanced Analytics, Data Analysis, Patient Safety, Clinical Trials, Clinical Research, Communication, Statistical Analysis, and Statistical Reporting

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

David M. Shade, JD
Johns Hopkins University
2 Courses20,432 learners

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