In the complex field of medical products, there's a need for professionals who understand the regulatory framework and can apply regulations, guidelines and standards to ensure compliant conduct of clinical research. This program concentrates on the regulatory aspects of clinical research management to ensure the safety and efficacy of medical products. You’ll also go beyond the operational aspects of conducting clinical research to understanding the FDA regulations and requirements for bringing medical products to market. With a regulatory science degree concentration, you’ll have the ability to advance medical care and treatment while ensuring new discoveries adhere to regulations that keep patients safe.
Upon graduation, you’ll be prepared to apply the regulations, standards and guidelines that are applicable to medical products through the product life cycle including:
- Clinical testing.
- Conducting clinical trials to prove safety and efficacy.
- Postmarketing surveillance of the medical product.
- Preclinical testing.
- Submitting to the FDA for marketing approval.
Who’s a good candidate for this master’s program?
As an ideal candidate, you should have a bachelor's degree in a science-based program. Although not required, it would also be beneficial to have previous medical experience or familiarity with medical products and regulatory affairs. This program is a good fit if you're looking to expand your abilities in regulatory writing techniques, quality assurance and medical device management. You’ll also develop an understanding of how to meet regulatory oversight requirements related to conducting clinical studies. Additionally, this online master’s also offers the flexibility to study part-time if it’s more conducive to your schedule due to other obligations.
Arizona State University’s online Master of Science in clinical research management with a concentration in regulatory science covers a broad oversight of clinical research, drug and device development, the approval processes and the regulations that govern the pharmaceutical industry. In this program, you’ll also learn advanced techniques on researching and managing trials, with an emphasis on the regulatory aspects of research.
In this program, you’ll cover topics ranging from research monitoring and operations to medical device development and quality assurance. You’ll also complete group projects and a capstone project focused on advancing your abilities to manage aspects of the regulatory process.
The Edson College of Nursing and Health Innovation is the home to world-renowned and award-winning faculty members. Our faculty’s accomplishments include, but aren’t limited to:
- Fulbright Senior Scholar.
- National faculty nursing awards.
- Rosalynn Carter National Leadership Award in Caregiving.
- Ruth B. Freeman Award from the American Public Health Association.
ASU’s Edson College of Nursing and Health Innovation provides a world-class education to students across various health disciplines. We distinguish ourselves by delivering excellent programs and challenging courses led by high-quality instructors.
undergraduate, graduate and certificate programs online.
faculty members.
in research expenditures.
students.
Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.
Applicants are eligible to apply to the program if they have a bachelor's or master's degree. Previous coursework or knowledge of anatomy, physiology and medical terminology is highly recommended.
Applicants must have a minimum of a 3.00 cumulative GPA (scale is 4.00 = "A") in the last 60 semester hours or 90 quarter hours of a student's first bachelor's degree program, or applicants must have a minimum of a 3.00 cumulative GPA (scale is 4.00 = "A") in an applicable master's degree program.
All applicants must submit:
- Graduate admission application and application fee.
- Official transcripts.
- Resume or curriculum vitae.
- Two references.
- Proof of English proficiency.
- Proof of six months of experience conducting clinical research.
You must submit a personal statement that describes your purpose for pursuing this degree and what you hope to accomplish with it. Please limit your response to one page, double-spaced with 12-point font and one-inch margins.
An interview may also be required. If so, we’ll contact you shortly after we receive your completed application to schedule.
An applicant whose native language is not English (regardless of current residency) must provide proof of English proficiency.
The online references should be from professional colleagues, supervisors, professors or other professional contacts and should attest to the applicant's academic and leadership experiences.
The applicant's resume or curriculum vitae must show six months of full-time related clinical research work or internship experience. The applicant may be required to submit a job description or internship transcript.
Students who do not meet the six-month related work or internship requirement may be eligible for a bridge option.
How the bridge option works: Applicants will apply for the degree program as normal. The applicant will be declined admission, but may be provisionally accepted if they agree to take three additional courses on the fundamentals of clinical research management. Once the applicant successfully passes those courses, they are accepted into the program and start the core classes.
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.