• Course Delivery
    Online
  • Total Credits
    120
  • Tuition
    $71,400.00
  • Duration
    2 years

Dual Degree: BSHS in Clinical Research Administration to MSHS in Regulatory Affairs Program Overview

Our multi-level, dual-degree learning option provides you with a seamless way to earn your BSHS in Clinical Research Administration and an MSHS in Regulatory Affairs through an accelerated format, allowing you to earn your BSHS and MSHS in less time by combining the work toward both degrees.

You'll learn to:

  • Apply Good Clinical Practice (GCP) regulations to ensure clinical trials meet sponsor needs, investigator goals, and regulatory standards. 
  • Understand pre- and post-market requirements for medical products as governed by domestic and international law. 
  • Develop and manage ethical clinical trials that address cultural considerations and meet commercial needs. 
  • Employ business principles and lead strategic decision-making in a variety of health care roles. 

Who Is the Ideal Student for This Program?
If you are driven to be a leader in the rapidly growing clinical research field, and interested in how new medical products intersect with legal and ethical frameworks, this degree program could be for you. From the foundations provided in the clinical research administration BSHS, to the finer points of regulatory affairs in the MSHS program, this online program is designed to prepare you for the challenges of today's health care innovation sector. To succeed, you should be self-disciplined, self-directed and ready to collaborate with faculty and classmates online.   

Career Outlook

With the skills you will gain in our dual-degree program in clinical research administration and regulatory affairs, you will be ready to enter a variety of jobs throughout the medical innovation field:

  • Operations Research Analyst, $81,390 median salary
  • Regulatory Affairs Specialist, $64,476 median salary
  • Regulatory Compliance Officer, $61,374 median salary
  • Clinical Trial Manager, $98,021 median salary

Request More Information
To learn more about the online Masters in Clinical Microbiology, contact an Admissions Advisor today at (844) 386-7323.

1. https://www.bls.gov/ooh/math/operations-research-analysts.htm 
2. https://www.payscale.com/research/US/Job=Regulatory_Affairs_Specialist/Salary 
3.https://www.payscale.com/research/US/Job=Regulatory_Compliance_Officer/Salary 
4. https://www.payscale.com/research/US/Job=Clinical_Trial_Manager/Salary 


Admissions Requirements

To be accepted to this program, you must have:

  1. An associate degree

    Verification of high school graduation or completion of GED unless already have an earned associate’s degree or higher.

  2. 3.3 GPA or above on a 4.0 scale
  3. Completed coursework

    Completed credits should include 3 credits English Composition, 4 credit Natural or Physical Science with Lab, 6 credits Social Sciences, 6 credits Humanities, Advanced Standing: 44 credits of advanced standing Non-traditional credit sources may be considered on a case-by-case basis (i.e. military coursework, credit-by-exam, and non-college based health programs).

  4. A written personal statement

    Please include a 250-500 word essay describing your reasons for undertaking study at the George Washington University, and your academic objectives, career goals, and related qualifications, including collegiate, professional, and community activities, relevant to your program of interest. Include any substantial accomplishments not already mentioned on the application form.

  5. Completed Application
  6. Resume/CV
  7. Application Fee: A non-refundable application fee of $80 is required. The application fee is waived for active-duty U.S. military, current GW students, degree-holding GW alumni, current McNair Program Scholars.
  8. One Letter of Recommendation
  9. Official transcripts from every school attended
  10. International Students: Applicants who are not U.S. citizens are also required to submit official test scores for Test of English as a Foreign Language (TOEFL) or Pearson’s Test of English (PTE) Academics or the academic International English Language Test System (IELTS). The following are the minimum scores for admission consideration: TOEFL: 250 computer-based or 100 Internet-based GW's school code for the TOEFL is 5246. PTE: overall score of 86 IELTS: overall band score of 7.0, with no individual band score below 6.0 International applicants may be considered for admission without submitting the above scores if: You are a citizen of a country where English is the official language, You hold a bachelor’s degree from a country where English is the official language and language of instruction, You hold a bachelor’s degree from an institution accredited by a U.S. regional accrediting agency.
NOTE: This program is authorized, exempt, or not subject to state regulatory compliance and may enroll students from all 50 states, U.S. territories and the District of Columbia.

Key Dates

Application Deadline
Start Date
August 7
August 27

Courses

This multi-level online dual degree program offers academically qualified individuals a seamless and accelerated pathway for completing both the Bachelor of Science in Health Sciences (BSHS) in Clinical Research Administration and the Master of Science in Health Sciences (MSHS) in Regulatory Affairs. Undergraduate and graduate degrees will be conferred sequentially, with the BSHS awarded upon completion of 120 credits (nine of which are taken for graduate credit). The MSHS is awarded following completion of an additional 27 credits (9 courses) of graduate coursework including one elective course.

*Course is taken as an undergraduate and applied to both the BSHS and MSHS curriculum. 

**Courses to be completed in the MSHS in Regulatory Affairs program. 

Core
  • CRA 2102Processes of Clinical Research3 Credits

    The student examines the process steps and regulatory requirements governing the development and registration of investigational new products from different stakeholder perspectives as well as the steps and requirements in the conduct of a clinical trial for an investigational new drug or device while ensuring data integrity and human subjects protection.

  • CRA 2104The Business of Clinical Research3 Credits

    The student compares and contrasts the business priorities of sponsors, sites and third party vendors, such as contract research organizations (CROs); the student also examines the business considerations in preparing clinical trial budgets including outsourcing and potential trial delays.

  • HSCI 6264Epidemiology for Clinical and Translational Research**3 Credits

    Provides an introduction to the way epidemiologists explore individual characteristics and their influences on public health, identify risk factors and health disparities of disease and provide information for preventive medicine through the use of descriptive studies, surveillance and analytical studies. The basic concepts and methods of epidemiology and their application in measuring, studying and improving the health of populations are discussed.

  • CRA 2101Basics of Clinical Research3 Credits

    The student explores the different phases of drug and device development and introduces basic concepts such as benefit-risk assessment, the different stakeholders, protocol, informed consent, clinical oversight, institutional review board, Good Clinical Practice (GCP), investigational clinical supplies, data management activities, safety reporting, and monitoring.

  • CRA 2103Good Clinical Practices3 Credits

    The student analyzes the rationale and goals of Good Clinical Practice (GCP), and applies key principles within the context of case studies.

  • CRA 2105Capstone in Clinical Research Administration3 Credits

    In this capstone course, students analyze business, ethical, cultural and practical aspects of clinical trial conduct; explore trends and technologies driving efficiencies in clinical trial performance and demonstrate how ethical and regulatory principles and trial management practices align to ensure quality and compliant clinical research conduct.

  • CRA 2107Introduction to Monitoring Clinical Trials3 Credits

    The student analyzes and evaluates the basic principles and processes involved in the monitoring of clinical trials, as well as the required documentation such as monitoring visit reports; the student also examines the role of key participants with emphasis on the clinical research associate.

  • HSCI 2102 Pathophysiology3 Credits

    Biomedical and scientific framework for the understanding of human disease mechanisms and biologic processes. Overview of infectious, immunologic, cardiovascular, genetic, respiratory, gastrointestinal, neoplastic, reproductive, renal, hematologic, neurologic, and musculoskeletal diseases.

  • HSCI 2103Health Policy and the Health Care System3 Credits

    Incorporates economic theory and policy analysis methodology to analyze the impact of changes in the health care system on the practice of health sciences professionals and the quality and process of health care. Development of critical thinking skills through review of current medical literature.

  • HSCI 2105Current Issues in Bioethics3 Credits

    Basic issues, approaches, and requirements of ethically acceptable decision making with patients, including patient confidentiality, conflicts of interest, allocation of scarce resources, occupational risks in health care, and professional responsibility for overall quality of care.

  • HSCI 2107Health Care in Literature3 Credits

    Literature, as well as TV and film, has shaped the public’s attitude toward health care for as long as storytelling and health care have coexisted. In the last hundred years, health care related discoveries have proliferated, benefiting from innovative research, while society remains plagued by many of the same problems such as the treatment of family violence, the extreme stigma of certain illnesses, or disparities in access and quality of health care. By studying literature, medical journals, as well as some visual media that have engaged with these and other health care issues, students will acquire a better understanding of how cultural attitudes toward health care are created, altered and reinforced. Through assignments students will explore how literature forms or expresses society’s opinions on controversial health care issues, and what these opinions mean for practitioners and patients.

  • HSCI 2112WWriting in the Health Sciences3 Credits

    Introduction to the health sciences literature. Emphasis is on construction, evaluation and organization of written communication of health sciences information.

  • HSCI 2113Informatics in the Health Sciences3 Credits

    Introduction to health care informatics, including management and clinical information systems and their role in administration, clinical, and research arenas in health care.

  • HSCI 3117Principles of Biostatistics for Health Sciences3 Credits

    Biostatistics for health science professionals. Concepts and methods, including confidence intervals, ANOVA, multiple and logistic regression, and non-parametric analyses. Scientific literature is used to provide a comprehensive context in which analytical evidence is employed to support practices in the health sciences. Prerequisites: HSCI 2117 or permission of the instructor.

  • HSCI 4103Health Care Law and Regulation3 Credits

    This is an upper division course intended to introduce students to the legal structures, rules, and mechanisms important to health care professionals, executives and organizations. Students analyze a range of legal standards related to medical malpractice and liability, fraud and abuse, and health care compliance. Since this is a health sciences course, trends in genetics, pharmacy law, and laboratory law will be discussed. In addition, students will become familiar with key legal terms, documents, and sources of law; the tools of communication and governance that shape health care arrangements and practices.

  • HSCI 4105Case Studies in Health Care3 Credits

    The goal of the course is to equip learners to examine issues in health care and develop multi-dimensional approaches and solutions.

  • HSCI 4106Introduction to Epidemiology3 Credits

    An introduction to epidemiological methods and their applications in the prevention and control of illness, community and clinical interventions, and health services.

  • HSCI 4112WResearch and Writing for Health Sciences3 Credits

    In this course, one of the key objectives is to work with you on your critical thinking, analytical, and integrative skills as a future graduate of the George Washington University.

  • HSCI 6223Topics in Health Care Leadership*3 Credits

    Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework. Students develop their own personal leadership philosophies through the various assignments.

  • HSCI 6240Issues and Trends in Health Systems*3 Credits

    Students examine the major themes on healthcare policies, trends, and issues in the major health systems and research enterprise. Students evaluate the larger contemporary issues, trends, policies, and implications that influence and shape current research and health care practices.

  • HSCI 6241The Health Care Enterprise**3 Credits

    Develop a clinical research enterprise strategic plan, while analyzing business considerations, such as marketing, economic sustainability, fiscal management, quality improvement and integrating technology. Through the development of a strategic plan, you will build an understanding of the intricacies of leading and managing a business unit and management principles in assignments throughout the semester.

  • HSCI 6263Biostatistics for Clinical & Translational Research**3 Credits

    Provides an introduction to the foundation of biostatistics, which is comprised of the design and analysis of clinical research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression and chi-square analysis. In addition, the course will examine the interpretation of output from statistical software (SPSS and SAS). Practice problems and review of scientific literature are also included to provide a comprehensive context in public health.

  • RAFF 6201Introduction to Global Regulatory Affairs*3 Credits

    Serves as a foundation for the entire program and is designed to provide students with a framework necessary to develop an integrated understanding of regulatory affairs. It looks at the big picture, covering U.S. and international legislation and regulatory processes guidelines, as well as the pivotal role that regulatory affairs leaders play in developing products, navigating the regulatory review and approval process and contributing to keeping products on the market.

  • RAFF 6202Regulatory Strategy in the Development of Drugs and Biologics**3 Credits

    Covers the development and evaluation of global regulatory strategies that support drug and biologic product development. In this course students analyze the critical elements of the product life cycle in the determination of a regulatory strategy, assess the roles of non-clinical and clinical data in determining regulatory strategy, appraise approaches for integrating strategic business needs into regulatory planning and evaluate the role of post-marketing efforts in shaping regulatory strategy.

  • RAFF 6203Regulatory Strategy in the Development of Devices and Diagnostics**3 Credits

    Provides a framework for the development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Objectives for this course are to analyze and evaluate the principle components of global regulatory strategy for devices and diagnostics, examine the regulation of medical devices through an epidemiological lens and analyze essential considerations associated with specific classifications or specialty areas of medical devices.

  • RAFF 6204Integration of Regulatory Science**3 Credits

    This course sources in the evaluation and assessment of regulatory strategies. Topics include protocol development, study design, post-marketing surveillance, evaluation and assessment of regulatory submissions. Through the framework of clinical trial design, we evaluate and assess strategies for achieving regulatory strategy in clinical development goals. The course introduces students to the planning and conduct of clinical trials. It provides an overview of clinical trials terminology and discusses issues related to clinical trial design. It discusses the components of a clinical trial including considerations regarding planning and carrying out a study. In the course we evaluate alternative clinical trial design options as conduits for achieving regulatory approval.

  • RAFF 6205Regulatory Compliance**3 Credits

    This course focuses on the analysis and evaluation of regulatory affairs compliance strategies and guidelines. Topics include pre- and post-marketing compliance, labeling, advertising and required reporting. In this course we identify and assess regulatory requirements, policies and guidelines associated with good practice (GXP) regulatory compliance issues. Students are required to critically analyze regulatory compliance issues and to integrate and develop implementation strategies for ensuring regulatory affairs compliance in medical product manufacturing, development, labeling and marketing. Students will need to demonstrate their ability to craft written regulatory communications including root cause analysis and corrective and preventive actions (CAPAs).

  • RAFF 6275Leadership and Change in Regulatory Affairs**3 Credits

    Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. This is a capstone course focusing on the concept of leading change within the contexts of health professionals, health systems and health policy. Organizational, management and change theories, as well as characteristics of personal and professional change leadership, are explored in relation to expectations for successful executive leadership and performance in today’s dynamic health care environments.

Elective
  • CML 6274Health Economics and Finance**3 Credits

    Issues of health care economics, financial management, and budgeting that relate to managerial decision-making. Applied financial management, management control systems, budgeting, staffing, and cost accounting.

  • CRA 6203Partnerships with Human Subjects**3 Credits

    This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.

  • CRA 6208International Clinical Research**3 Credits

    Analysis of the strategies and methods of clinical research in international settings; explore cultural and ethical consideration in global clinical research projects.

  • CRA 6209Quality and Risk Management**3 Credits

    This course explores how to manage risk and safety assessments to ensure quality in clinical research.

  • CRA 6210Medical Writing in Clinical Research**3 Credits

    Strategies and practices in writing documentation related to clinical research administration.

  • HCQ 6201Building a Quality Culture**3 Credits

    Covers the analysis of quality and patient safety challenges in U.S. health care with a focus on political and environmental influences.

  • HSCI 6223Topics in Health Care Leadership**3 Credits

    Allows students to think critically about leadership concepts by analyzing and evaluating academic articles associated with leadership, change management and systems development. It is designed to use course content as a mechanism for developing critical thinking skills. This is a course that requires academic writing, contrasting and comparing ideas and extrapolating current literature into practical application.

  • HSCI 6264Epidemiology for Clinical and Translational Research**3 Credits

    Provides an introduction to the way epidemiologists explore individual characteristics and their influences on public health, identify risk factors and health disparities of disease and provide information for preventive medicine through the use of descriptive studies, surveillance and analytical studies. The basic concepts and methods of epidemiology and their application in measuring, studying and improving the health of populations are discussed.

Tuition & Fees

Tuition for the BSHS undergraduate courses is $595 per credit hour. MSHS graduate course tuition is $925 per credit hour. 

  • Per Credit Hour
  • Tuition: $595.00
  • 3 Credit Hours
  • Tuition: $1,785.00

What's it like to earn this degree online?

  • Study on your schedule
    The flexible anytime, anywhere approach to online learning at GW means that you can study and work on assignments when and where it’s convenient for you. Balance your personal and professional commitments. At GW online, you can advance your career without stopping it.
  • Personalized learning
    Many of our online programs have a student-instructor ratio that’s lower than on-campus classes, making it easier to interact with fellow students and get personalized attention from your instructors. Plus, you have access to one-on-one tutoring to help ensure your success.
  • The prestige of a GW degree
    Now you can earn a GW degree without relocating your life, giving you access to the distinguished connections and opportunities we provide. When you earn a degree from an online program at GW, you earn a degree from the George Washington University. Entrusted with its rights, privileges, and honors, you’ll join the ever-expanding GW alumni community who make the world a better place.
  • Connect to campus from anywhere
    GW is your link to leading authorities in policy and health care in Washington, D.C. You’ll be able to research, collaborate, and discuss with classmates and instructors using online learning management systems. Engage with all the resources GW offers, including tutors, the writing center, career services, and libraries—all online.
  • A dedicated advisor from day one
    Each GW online student is assigned an academic advisor who will support your journey to graduation. You’ll get help finding resources, guidance on scheduling classes, answers to your questions, and more. As an online learner at GW, you’re never alone.
  • Round-the-clock tech support
    A late-night software malfunction won’t keep you from getting your assignment in on time. GW provides 24/7 technical support for our online students, ensuring you have complete access to what you need, when you need it.

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