Program Overview

Overview of the Online Master of Science in Clinical Research Management – Regulatory Science

The online Master of Science in Clinical Research Management with a concentration in Regulatory Science offered by Arizona State University covers a broad oversight of clinical research, drug and device development, the approval processes, and the regulations that govern the pharmaceutical industry. This program focuses on the regulatory aspects of clinical research management, ensuring the safety and efficacy of medical products.

Program Details

• Total classes: 11
• Weeks per class: 7.5
• Total credit hours: 33
• Next start date: 01/12/2026

Program Description

This program concentrates on the regulatory aspects of clinical research management to ensure the safety and efficacy of medical products. Students will learn advanced techniques for researching and managing trials, with an emphasis on the regulatory aspects of research. The program prepares students to apply regulations, standards, and guidelines applicable to medical products throughout the product life cycle, including clinical testing, conducting clinical trials, postmarketing surveillance, preclinical testing, and submitting to the FDA for marketing approval.

Ideal Candidate

The ideal candidate should have a bachelor's degree in a science-based program. Although not required, it would be beneficial to have previous medical experience or familiarity with medical products and regulatory affairs. This program is suitable for those looking to expand their abilities in regulatory writing techniques, quality assurance, and medical device management.

Courses

Required Courses

• Clinical Research Monitoring: Explores the monitoring function within the clinical research environment.
• Clinical Research Operations: Covers the operational skills necessary to develop, implement, and manage a clinical trial.
• Fundamentals of Regulatory Affairs: Provides an overview of regulatory authorities in new product development as they relate to medical product safety, efficacy, applications, and approvals.
• Responsible Conduct of Clinical Research: Covers ethical policies for the responsible conduct of research, institutional review boards, and dissemination of findings.
• Scientific and Research Review Boards: Analyzes the functions of the scientific review boards, including the basis for the review board’s authority and the regulations that govern their activities.

Concentration Courses

• Clinical Research Data Management and Technology Implementation: Covers database design and management, technology assessment methods, and data auditing procedures for continuous quality improvement (CQI) in clinical research.
• Medical Device Development and Regulation: Explores the regulatory framework for the design, development, approval/clearance, and marketing of medical devices in the U.S. throughout the product life cycle.
• Pharmaceutical Safety and Risk Management: Covers the comprehensive examination of regulatory, legal, and scientific factors in pharmacovigilance, including risk management and risk mitigation.

Career Opportunities

After completing this master’s in Clinical Research Management with a concentration in Regulatory Science, students will be prepared for a wide range of career opportunities, including:

• Clinical research associate
• Compliance officer
• Quality assurance specialist
• Regulatory affairs manager
• Regulatory affairs specialist
• Regulatory submission manager

Faculty and Accreditation

The Edson College of Nursing and Health Innovation is home to world-renowned and award-winning faculty members. The college provides a world-class education to students across various health disciplines, distinguishing itself by delivering excellent programs and challenging courses led by high-quality instructors.

Application Requirements

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

• A bachelor's or master's degree
• 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 in an applicable master's degree program
• Official transcripts
• Resume or curriculum vitae
• Two references
• Proof of English proficiency
• Proof of six months of experience conducting clinical research
• A personal statement describing the purpose for pursuing this degree and what the applicant hopes to accomplish with it

An interview may also be required. If so, the university will contact the applicant shortly after receiving the completed application to schedule.

Additional Information

• Tuition Calculator: Available to estimate full-time or part-time tuition fees for this program prior to any financial aid.
• FAQs: Address questions about regulatory affairs, lab management, and the program, including job placement assistance, publication of the capstone project, and mentorship programs.