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.