ASU Online Clinical Research Management & Regulatory Science Programs

• Clinical Research Management (Grad Certificate)
• Clinical Research Management (MS)
• Clinical Research Management - Regulatory Science (MS)
• Regulatory Science (MS)
• Regulatory Science (MS) - Food Safety

By Sara Navratil Reviewed By Jocelyn Blore Reviewed By School

Updated January 9, 2024

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Arizona State University’s College of Nursing and Health Innovation offers an online master of science (MS) in clinical research management, an online MS in clinical research management with a regulatory science concentration, an MS in regulatory science, and an MS in regulatory science – food safety. ASU also offers a graduate certificate in clinical research management.

The clinical research management degrees and certificate are transdisciplinary programs that focus on educating students in commerce, clinical research financial practices, the ethics of research, regulations for research, and managing medical device and pharmaceutical trials. Additionally, the programs integrate the introduction of entrepreneurship and innovation into the area of clinical research.

Clinical research managers and regulatory science professionals need to communicate effectively with colleagues and employees, have excellent technical writing skills, and work independently. Additionally, these industry leaders need skills and knowledge in medical device development and regulation, pharmaceutical safety, proper data management, and clinical research monitoring and regulations.

In addition to the main tenets of the clinical research management MS, the regulatory science concentration incorporates coursework in medical device and pharmaceutical regulation, quality systems, and regulatory writing techniques to prepare clinical research managers to meet the required regulations of clinical trials.

The MS in regulatory science focuses on protecting public health through the regulation of medical devices, pharmaceuticals, and other medical products. Students focus on quality systems, legal issues, clinical research, and global medical product regulation throughout the program. This degree path is also transdisciplinary, allowing graduates to work with medical product companies and the regulating entities involved. 

ASU’s College of Nursing and Health Innovation has a partnership with the Mayo Clinic, pairing Mayo’s extensive clinical research background with ASU’s innovative leadership focus. This partnership has created high-impact programs that make a difference in the healthcare world. 

Taking regulatory science into the food supply chain, the MS in regulatory affairs – food safety degree and the food safety and protection graduate certificate prepare graduates to handle all aspects of food safety regulation including inspection, safe food practices including preparation, storage, and the processing of food, hazard analysis, and how to approach food emergencies. The curriculum for this degree aligns with the material found on the Certified Professional – Food Safety certification exam through the National Environmental Health Association (NEHA). This degree path offers a transdisciplinary approach to working with the food industry and the regulating entities involved. 

According to U.S. News and World Report, ASU’s College of Nursing and Health Innovation ranks in the top 11 percent of the nation for its master’s programs. U.S. News also awarded ASU the title of  “most innovative in the nation” three years in a row.

Clinical research management and regulatory science notably befit doctors, nurses, and others in the healthcare field. The MS in regulatory science – food safety and the food safety and protection graduate certificate are designed for those who wish to serve local, state, and federal entities such as the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and state and county health departments. Food safety regulators may also work for food manufacturers.

Applicants to the online MS in clinical research management and the regulatory science concentration program must have at least six months of experience in a clinical research setting as outlined below in the admissions requirements. Prospective students may have a bachelor’s degree in a field that included courses in anatomy, physiology, and medical terminology, or have documentation that they took these courses in addition to their bachelor’s degree.

Graduates of the MS in clinical research management may go on to positions such as clinical data manager, clinical lab technician, clinical nurse specialist, social science research assistant, and others. Graduates from the MS in clinical research management with a concentration in regulatory science may move into careers in clinical research management, teaching science, agricultural and food science, and regulatory roles in medical device and pharmaceutical companies. Those who earn the Graduate certificate in clinical research management may go on to positions such as clinical research associate, clinical research coordinator, or clinical research supervisor.

Regulatory science MS graduates may become regulatory affairs professionals, regulatory scientists, and regulatory coordinators among other medical product regulatory positions.  Food safety graduates may go on to positions with food companies or government agencies such as food inspector, food-safe chemical supplier, area director, regulatory investigator, quality control manager, environmental health and safety coordinator, and quality assurance manager.

ASU is located in Phoenix, Arizona, with five campuses in the Phoenix metropolitan area. They also have an undergraduate campus in Lake Havasu City. The MS in clinical research management is accredited through the Commission on Accreditation of Allied Health Education Programs (CAAHEP).

Admission Requirements: Candidates must submit a graduate application and application fee, professional recommendations, official transcripts, a current resume, and proof of English language proficiency (if applicable). Applicants to the MS degrees must hold a bachelor’s or master’s degree from a regionally accredited institution with a minimum GPA of 3.0. Applicants to the regulatory science graduate certificate must hold a bachelor’s degree with a minimum GPA of 3.0 in the last 60 credits, or a master’s degree with a minimum GPA of 3.0. The bachelor’s degree must show evidence of additional courses in anatomy, physiology, and medical terminology. An interview is required for all applicants.

Clinical research management applicants should have completed courses in anatomy, physiology, and medical terminology, or proof that applicants completed these prerequisite courses beyond their degree. In addition, all clinical research management applicants must have six months of full-time related clinical research work or internship and submit three letters of recommendation. Clinical research management graduate certificate applicants must also submit a personal statement, two letters of recommendation, and respond to application questions in addition to the requirements above.

Regulatory science applicants must also submit two professional references and a personal statement including short-term and long-term goals and field interests. 

Food safety and protection graduate certificate students must hold a bachelor’s or master’s degree in a science-based or related field and submit three letters of recommendation, a written statement, official transcripts, a professional resume, and proof of English language proficiency if applicable.

Study Plan: Classes run 7.5 weeks each and the MS degrees consist of 11 courses. Most part-time students take one course per 7.5-week session or five courses per year, so degree completion takes about two years. Students can choose to attend full-time and take up to 18 credits in the spring and fall and up to seven credits in the summer. The clinical research management and the food safety and protection graduate certificates comprise five courses and can be completed in one year.

Note that not all courses are offered each session, so full-time attendance may not be possible for these degrees. There is an optional two-day orientation program offered. The clinical research management programs end with a capstone clinical research project course. Start dates are offered in January, March, May, August, and October.

Clinical Research Management Coursework: Both programs consist of 33 credits and have the following core courses: responsible conduct of clinical research, clinical research monitoring, clinical research operations, the fundamentals of regulatory affairs, and scientific and research review boards. Both degree sequences end with a capstone course.

The general MS in clinical research management also includes healthcare project management, institutional review board in human research, research management and contemporary research projects, research design and methods for clinical research and regulatory science, clinical research data management and technology implementation, and either medical device development and regulation or three more credits of the clinical research management capstone.

The 15 credits of concentration courses in regulatory science include instruction in quality assurance and clinical research, medical device development and regulation, pharmaceutical safety and risk management, clinical research data management and technology implementation, and technical writing for the regulatory professional.

The online clinical research management graduate certificate consists of five courses or 15 credits. It includes responsible conduct of clinical research, fundamentals of regulatory affairs, clinical research data management and technology, clinical research operations, and one elective.

Regulatory Science Coursework: The regulatory science and food safety degrees comprise 33 credits over 11 courses. Core courses for both pathways include quality assurance and clinical research; responsible conduct of clinical research; fundamentals of regulatory affairs; drug discovery, development, and regulations; global regulatory affairs, and legal aspects of clinical research. A culminating applied project course is also included.

Regulatory science MS students then choose 12 credits from the following courses: medical device development and regulation; clinical research design and methods; pharmaceutical safety and risk management; technical writing for the regulatory professional; global regulatory affairs leadership; health care project management; management and negotiation of clinical trial budgets and contracts; and translational research in drug discovery and development. 

Regulatory science – food safety MS students take food safety and protection; assessing food safety and developing policy procedures and training; quality assurance and safety in food and dietary supplements; and technical writing for the regulatory professional. 

Online Experience: Generally, most courses are asynchronous, meaning students can observe the recording at any time and complete assignments in their own time frame by the posted due dates. Some courses or parts of courses may have specific login times for certain assignments or activities. Additionally, some assignments and tests may only be available for a limited time window (e.g., 24 to 48 hours). ASU online courses are taught using Blackboard and students are expected to be able to communicate with others online, send and receive information, and complete research. Students are encouraged to use a Mac or PC with a webcam, headset, and microphone to ensure they have access to all multimedia tools and resources.

On-Site Requirements: There are no on-site requirements for the MS in clinical research management, regulatory science, and graduate certificate programs as they are 100 percent online. There is an optional two-day orientation program available. Students are welcome to visit campus and are encouraged to participate in graduation on campus.

ASU Online charges slightly different rates for its various clinical research and regulatory science programs. Tuition numbers are listed in the tables below, and include a technology fee. Note that there may be other fees associated with the programs, and those would be additional. Tuition figures can be confirmed using the ASU Tuition Estimator. Prospective students should contact the admissions department of the programs for exact costs.

ASU Online offers financial aid in the form of scholarships, grants, federal work-study, and loans. Students are also encouraged to seek outside resources for help paying for their MS degree. Company employees can check if their employer offers a tuition reimbursement program for workers seeking a higher education degree.

Sara Navratil

Writer

Sara Navratil is a freelance writer and a Certified Canfield Success Principles Trainer. She's the owner of Sara Liza Life, a company dedicated to helping people rewrite their lives. She enjoys researching and writing about healthcare-related topics, including information on online MHA programs. When not working she likes to read, bake, and spend time with her family.