Clinical Research Management (Regulatory Science), MS
| Program start date | Application deadline |
| 2024-07-19 | - |
| 2024-09-15 | - |
| 2024-12-10 | - |
| 2024-02-15 | - |
| 2024-04-15 | - |
Program Overview
The Clinical Research Management (Regulatory Science) MS program prepares students for careers in clinical research management, focusing on regulatory science. Through online courses and a culminating experience, students gain expertise in regulatory writing, quality assurance, and ethical standards. The program is accredited by CAAHEP and offers internship opportunities, preparing graduates for careers as clinical research associates, project managers, and regulatory affairs specialists.
Program Outline
Clinical Research Management (Regulatory Science), MS
Degree Overview
This program prepares students for careers in clinical research management focusing on regulatory science. Regulatory affairs ensure new products meet regulatory requirements and standards, while regulatory science addresses the safety, efficacy, quality, and regulation of new medical products, diagnostics, and treatments. This program helps graduates advance medical care and treatment while ensuring new discoveries adhere to rules and regulations that keep patients safe.
Outline
- Degree awarded: MS in Clinical Research Management (Regulatory Science)
- Credits: 33 credit hours, including a culminating experience
- Concentration: Regulatory science
- Structure: Online courses, offered five times per year
- Part-time option: Available, allowing continued employment
Module Descriptions
- Regulatory Writing Techniques: Develop expertise in writing clear, concise, and legally compliant documents for clinical research studies.
- Quality Assurance: Learn effective quality assurance practices in the context of clinical research.
- Medical Devices and Drugs: Gain thorough knowledge of medical devices and drugs, regulatory requirements, and approvals.
- Pharmaceutical Safety and Risk Management: Understand and manage pharmaceutical safety risks for improved patient outcomes.
- Clinical Trial Management: Acquire the skills to effectively manage clinical trials, ensuring compliance and ethical conduct.
- Responsible Conduct of Clinical Research: Understand and apply responsible practices throughout the research process.
- Clinical Research Data Management and Technology Implementation: Develop expertise in managing and utilizing data effectively with technology.
- Fundamentals of Regulatory Affairs: Gain essential knowledge of regulatory affairs principles within the pharmaceutical industry.
- Clinical Research Operations: Learn the operational aspects of clinical research, including budget management and resource allocation.
- Scientific and Research Review Boards: Understand functions and regulatory implications of research ethics committees.
- Global Regulatory Affairs Leadership: Explore international regulatory frameworks and lead global regulatory strategies.
- Research Management and Contemporary Research Topics: Gain proficiency in research management and navigate evolving topics.
- Legal Aspects of Clinical Research: Understand legal regulations and ethical considerations pertinent to clinical research.
- Translational Research in Drug Discovery and Development: Explore the bridge between scientific discoveries and clinical applications.
- Clinical Research Management Capstone: Apply acquired knowledge and skills through a real-world research project.
Assessment
Assessment methods involve continuous course-specific projects, assignments, and discussions throughout the program. Each course requires specific projects and assignments for evaluation. The culminating experience involves a real-world research project with faculty guidance and submission of a paper.
Teaching
- Courses offer collaborative learning through interaction with faculty and peers.
- Faculty is composed of experienced professionals in diverse areas of clinical research and regulatory science.
- Flexible online format caters to working professionals seeking career advancement.
Careers
- Clinical research associate
- Project manager
- Quality control specialist
- Regulatory affairs manager
- Regulatory affairs specialist
Other
- The program is the first clinical research graduate program accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP).
- The program offers internship opportunities for experiential learning.
Arizona State University: A Comprehensive Overview
Overview:
Arizona State University (ASU) is a top-ranked research university located in the greater Phoenix metropolitan area. It is known for its innovative approach to education, offering a wide range of undergraduate and graduate programs across various disciplines. ASU is recognized for its commitment to inclusivity, serving learners at all stages of life and fostering a diverse and welcoming community.
Services Offered:
ASU provides a comprehensive range of services to support student success, including:
Academic Support:
Tutoring, advising, and academic success resources.Financial Aid:
Scholarships, financial aid programs, and tuition assistance.Student Life:
Housing and dining, clubs and activities, health and wellness services, and transportation.Career Services:
Job and career resources, internship opportunities, and career counseling.Student Life and Campus Experience:
ASU offers a vibrant and engaging campus experience with a strong sense of community. Students can participate in a wide array of clubs, organizations, and events, fostering personal growth and development. The university's diverse student body creates a rich cultural environment, promoting global perspectives and intercultural understanding.
Key Reasons to Study There:
Top-Ranked Programs:
ASU boasts numerous top-ranked programs, including 82 programs ranked in the top 25 nationally, with 37 in the top 10.Innovative Learning Environment:
ASU embraces a flexible and personalized approach to learning, allowing students to customize their academic journey.World-Class Faculty:
Students benefit from instruction led by renowned professors and researchers, many of whom are leaders in their fields.Global Impact:
ASU is consistently ranked among the top universities for global impact, demonstrating its commitment to addressing global challenges.Diverse and Inclusive Community:
ASU fosters a welcoming and inclusive environment, embracing students from all backgrounds and promoting a sense of belonging.Academic Programs:
ASU offers over 800 degree programs across a wide range of disciplines, including:
Undergraduate:
More than 400 undergraduate degrees in fields such as engineering, journalism, business, sustainability, nursing, education, and more.Graduate:
Over 450 graduate degrees, including master's and doctoral programs.Other:
ASU is known for its commitment to research and innovation, with a strong focus on addressing real-world challenges. The university is also a leader in sustainability, promoting environmental responsibility and social justice.
Entry Requirements:
For All Applicants:
- A bachelor's or master's degree from an accredited institution.
- A minimum cumulative GPA of 3.00 (on a 4.0 scale) in the last 60 credit hours of the first bachelor's degree or in a relevant master's degree program.
- Completion of an online application and payment of the application fee.
- Official transcripts from all previously attended colleges and universities.
- A resume or curriculum vitae.
- Three online references from colleagues, supervisors, or other professional contacts who can attest to your academic and professional experiences.
Additional Requirements for International Applicants:
- Proof of English proficiency, regardless of current residency, as demonstrated through one of the following:
- TOEFL score of at least 80
- IELTS score of at least 6.5
- PTE Academic score of at least 53
- Six months of full-time clinical research work or internship experience, as detailed in your resume or curriculum vitae. Applicants without this experience are required to complete the foundation courses offered by the program before enrolling in other courses.
Additional Notes:
- Courses or background knowledge in anatomy, physiology, and medical terminology are recommended for all applicants.
Language Proficiency Requirements:
- A TOEFL score of at least 80
- An IELTS score of at least 6.5
- A PTE Academic score of at least 53 These scores must be achieved on a test taken within the past two years. Applicants who have earned a bachelor's or master's degree from a university where English is the primary language of instruction may be exempt from these requirements.
Summary:
To be eligible for the Clinical Research Management (Regulatory Science), MS program at Arizona State University, applicants must hold a bachelor's or master's degree with a minimum GPA of 3.00, submit a completed online application and fee, official transcripts, a resume, and three references. International students require English proficiency scores and may need to complete foundational coursework.
