Online Master of Science in Clinical Research Management – Regulatory Science

The role of clinical research managers is expanding. To prepare for a regulatory affairs job, the Master of Science in clinical research management with a concentration in regulatory science takes a transdisciplinary approach. It provides education that focuses on clinical research and managing trials, with an emphasis on the regulatory aspects of research.

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Quick facts

Next start date:

Next start date: 05/16/2024


Total classes:

Total classes: 11

Weeks per class:

Weeks per class: 7.5

Total credit hours:

Total credit hours: 33

Degree questions, answered.

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What is regulatory science and regulatory affairs?

Regulatory science addresses the safety and efficacy of new medical products, diagnostics and treatments. Regulatory affairs ensure new products meet the regulations and standards set by governing agencies.

This master’s program aligns regulations with science in the lifecycle of medical products. With a regulatory science degree concentration, you’ll have the ability to advance medical care and treatment while ensuring new discoveries adhere to rules and regulations that keep patients safe.

Become a regulatory scientist

 

The regulatory science concentration of this clinical research management master’s program emphasizes regulatory affairs and regulatory sciences. In this rigorous program, coursework will include regulatory writing techniques, quality assurance, medical devices and drugs, and pharmaceutical regulation. You’ll also develop your understanding of how to meet regulatory oversight requirements as they relate to the conduct of clinical studies.

Get started in regulatory science today

 

As an adult learner, you can enjoy the flexibility of online learning in this 33-credit-hour program. You also have the opportunity to take advantage of part-time study if it’s more conducive to your learning style. You can take all your courses online and complete a required six-semester-hour capstone clinical research project.

This clinical research management graduate degree is the first clinical research graduate degree to receive accreditation from the Commission on Accreditation of Allied Health Education Programs. The CAAHEP is the largest programmatic accreditor in the health sciences field and is recognized by the Council for Higher Education Accreditation in the U.S. and internationally.

Will my clinical research management degree say 'online'?

No, Arizona State University’s diplomas don’t specify whether you earn your degree online or in person. All diplomas and transcripts simply say “Arizona State University.” That’s because ASU Online students learn from the same faculty and receive the same course content as in-person students receive.

Your concentration in regulatory science will appear on both your diploma and transcripts.

Laboratory management and regulatory affairs courses

Courses in this program include individual and group projects designed to prepare you to manage aspects of the regulatory process. You’ll learn about topics ranging from research monitoring and operations to medical device development and quality assurance. Courses may include:


Required

Clinical Research Monitoring


Required

Responsible Conduct of Clinical Research


Required

Fundamentals of Regulatory Affairs


Required

Clinical Research Operations


Required

Scientific and Research Review Boards


Concentration

Medical Device Development and Regulation


Concentration

Quality Assurance and Clinical Research


Concentration

Pharmaceutical Safety and Risk Management


What can I do with a degree concentration in regulatory science?

Graduates from the Master of Science in clinical research management with a concentration in regulatory science degree have a range of career opportunities to explore. Career examples include but are not limited to:

Quality control specialist

Regulatory affairs manager

Regulatory affairs specialist

Clinical research associate

Project manager

Regulatory and lab management skills from health professionals

The Edson College of Nursing and Health Innovation is the home to world-renowned faculty members.

  • Countless national faculty nursing awards. 
  • Fulbright Senior Scholar. 
  • Rosalynn Carter National Leadership Award in Caregiving. 
  • Ruth B. Freeman Award from the American Public Health Association.

Regulatory and lab management skills from health professionals

The Edson College of Nursing and Health Innovation is the home to world-renowned faculty members.

  • Countless national faculty nursing awards. 
  • Fulbright Senior Scholar. 
  • Rosalynn Carter National Leadership Award in Caregiving. 
  • Ruth B. Freeman Award from the American Public Health Association.

How to apply

Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.

Application requirements

Additional application information

Join one of the best nursing and health colleges in the nation

ASU’s Edson College of Nursing and Health Innovation provides a first-class education to students across a wide range of health disciplines. The college distinguishes itself through high-quality instructors and challenging courses and programs.

10+


undergraduate, graduate and certificate programs online.

250+


faculty members.

$13.2 million


in research awards.

4,000+


students.

Tuition calculator

Use our calculator to estimate your full-time or part-time tuition fees for this program prior to any financial aid. Keep in mind that most of our students receive financial aid, which can reduce out-of-pocket costs. Learn more.

Tuition calculator

Use our calculator to estimate your full-time or part-time tuition fees for this program prior to any financial aid. Keep in mind that most of our students receive financial aid, which can reduce out-of-pocket costs. Learn more.

FAQs about regulatory affairs and lab management

What is regulatory affairs?

Will the college help me find a job in regulatory science?

Can the capstone project be published?

Is there a mentorship program?

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