Clinical Research Management (Regulatory Science), MS
Medical Device Regulation, Quality Assurance, Regulatory Affairs, Regulatory Science, Regulatory Writing
Are you ready to elevate your career in clinical research and regulatory affairs? This fully online program is the perfect opportunity to advance your expertise. Open doors to exciting new possibilities in the field of clinical research management with a focus in regulatory science.
Clinical research management is a dynamic and growing field encompassing medical, health and research professionals who lead and conduct clinical trials for innovative medical products.
Regulatory affairs ensure that new products meet the requirements and standards set by regulatory authorities; and regulatory science addresses the safety, efficacy, quality and regulation of new medical products, diagnostics and treatments. The Master of Science program aligns regulations and national competencies throughout the life cycle of medical products. With a master's degree in clinical research management and a focus on regulatory science, you can advance medical care and treatment while ensuring that new discoveries adhere to rules and regulations that keep patients safe.
The regulatory science concentration of this program offers you a robust blend of skills in clinical research management and regulatory affairs and sciences. Coursework in this rigorous program includes regulatory writing techniques, quality assurance, medical devices and drugs, and pharmaceutical safety and risk management, ethical standards and regulation, in addition to clinical trial management.
This program meets your needs as a professional adult learner and provides the flexibility of online courses, allowing for enrollment five times per year. You can complete the program on a part-time basis, enabling you to continue to work while earning your degree.
The program has the distinction of being 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.
- College/school:
Edson College of Nursing and Health Innovation
- Location: Online
- STEM-OPT extension eligible: No
33 credit hours including the required capstone course (HCR 566)
Required Core (18 credit hours) Concentration (12 credit hours) Culminating Experience (3 credit hours)
HCR 551 Clinical Research Monitoring (3)
HCR 561 Responsible Conduct of Clinical Research (3)
HCR 562 Clinical Research Data Management and Technology Implementation (3)
HCR 563 Fundamentals of Regulatory Affairs (3)
HCR 565 Clinical Research Operations (3)
HCR 574 Scientific and Research Review Boards (3)
HCR 552 Medical Device Development and Regulation (3)
HCR 553 Quality Assurance and Clinical Research (3)
HCR 555 Pharmaceutical Safety and Risk Management (3)
HCR 557 Clinical Research Design and Methods (3)
HCR 558 Technical Writing for the Regulatory Professional (3)
HCR 564 Global Regulatory Affairs Leadership (3)
HCR 567 Research Management and Contemporary Research Topics (3)
HCR 578 Legal Aspects of Clinical Research (3)
HCR 579 Translational Research in Drug Discovery and Development (3)
HCR 566 Clinical Research Management Capstone (3)
General university admission requirements:
All students are required to meet general
university admission requirements.
U.S.
applicants | International
applicants | English
proficiency
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 earned a bachelor's or master's degree from a regionally accredited institution.
Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in the last 60 credit hours or 90 quarter hours of their first bachelor's degree program or a minimum cumulative GPA of 3.00 in an applicable master's degree program.
All applicants must submit:
- graduate admission application and application fee
- official transcripts
- resume or curriculum vitae
- three online references
- proof of English proficiency
Additional Application Information
An applicant whose native language is not English must provide proof of English proficiency regardless of their current residency.
The applicant must have six months of full-time, related clinical research work or internship experience as described in a resume or curriculum vitae. Applicants without six months of experience are required to complete the research foundation courses provided through the program prior to enrollment in any courses.
The online references should be from colleagues, supervisors or other professional contacts and should attest to the applicant's academic and leadership experiences.
Courses or a background in anatomy, physiology and medical terminology are recommended.
ASU offers this program in an online format with multiple enrollment sessions throughout the year. Applicants may view the program’s ASU Online page for program descriptions and to request more information.
| Session | Modality | Deadline | Type |
|---|---|---|---|
| Session A/C | Online | 07/19 | Final |
| Session B | Online | 09/15 | Final |
| Session | Modality | Deadline | Type |
|---|---|---|---|
| Session A/C | Online | 12/10 | Final |
| Session B | Online | 02/15 | Final |
| Session | Modality | Deadline | Type |
|---|---|---|---|
| Session A/C | Online | 04/15 | Final |
Program learning outcomes identify what a student will learn or be able to do upon completion of their program. This program’s learning outcomes include the following:
- Evaluate regulatory and scientific evidence to develop clear, defensible conclusions in regulatory submissions and communications.
- Synthesize ethical and regulatory requirements to determine appropriate compliance actions for protecting human subjects and ensuring responsible clinical research conduct.
- Integrate regulatory, ethical, and scientific evidence to develop strategic solutions that enhance the quality, safety, and global regulatory compliance of clinical research.
Graduates with an MS in clinical research management with a focus on regulatory science have a variety of career opportunities to explore. Career examples include:
- clinical data analyst
- clinical research associate or coordinator
- clinical trial regulatory coordinator
- medical device consultant
- project manager
- quality control specialist
- regulatory affairs consultant
- regulatory affairs manager
- regulatory writer or technical documentation specialist
ASU programs that may lead to professional licensure or certification are intended to prepare students for potential licensure or certification in Arizona. Completion of an ASU program may not meet educational requirements for licensure or certification in another state. For more information, students should visit the ASU professional licensure webpage.
Edson College of Nursing and Health Innovation
|
HLTHN 301
EdsonCollege.Graduate@asu.edu
602-496-0937
Program term definitions
Accelerated programs allow students the opportunity to expedite the completion of their degree.
Accelerated master's
These programs allow students to accelerate their studies to earn a bachelor's plus a master's degree in as few as five years (for some programs).
Each program has requirements students must meet to be eligible for consideration. Students typically receive approval to pursue the accelerated master's during the junior year of their bachelor's degree program. Interested students can learn about eligibility requirements and how to apply.
Concurrent degrees allow students to pursue their own personal or professional interests, earn two distinct degrees and receive two diplomas. To add a concurrent degree to your existing degree, work with your academic advisor.
Joint programs, or jointly conferred degrees, are offered by more than one college and provide opportunities for students to take advantage of the academic strengths of two academic units. Upon graduation, students are awarded one degree and one diploma conferred by two colleges.
ASU adds new programs to Degree Search frequently. Come back often and look for the "New Programs" option.
ASU Online offers programs in an entirely online format with multiple enrollment sessions throughout the year. See https://asuonline.asu.edu/ for more information.
The Western Regional Graduate Program (WRGP) provides a reduced tuition rate to non-resident graduate students who qualify. Visit the WRGP/WICHE webpage for more information: https://graduate.asu.edu/wiche.
