The Bachelor of Science in Integrated Studies: Clinical Research Management is designed for learners in the early stages of a career in clinical research, as well as for more experienced individuals such as investigators, coordinators, and sponsor representatives who want to expand their knowledge and skills in the field. The program lays a foundation in principles and applications from the basic sciences and then covers in greater depth the processes necessary for the management of studies that develop drugs, devices, and treatment protocols for patient care.
This customized undergraduate program focuses on the scientific methods of clinical research, good clinical practice, research ethics, and the regulatory guidelines that protect human subjects, all of which are integral components of clinical trial management in academic research or pharmaceutical industry settings.
This program is completed entirely online.
Contact Info
| Contact: | CAPS |
| Phone: | 314-935-6700 |
| Email: | CAPS@wustl.edu |
| Website: | https://caps.washu.edu/programs/undergraduate-programs/bachelor-of-science-in-integrated-studies-degree-programs/bsis-clinical-research-management/ |
All WashU Continuing & Professional Studies (CAPS) BSIS students must satisfy the same general-education requirements.
Learners in BSIS programs must complete a certificate, tailoring their degree to their educational and professional goals. Learners in the Clinical Research Management program may fulfill this requirement with the overlapping Certificate in Clinical Research Management. In some cases, those with extensive work experience and/or a significant number of transfer credits may have the certificate requirement waived. Requests for waiving the certificate requirement are reviewed and approved by CAPS on a case-by-case basis.
Learners in BSIS programs must also complete a Community Engagement course. A designated CAPS course will fulfill this requirement.
Requirements specific to the field of study include the following:
Required Courses: 40 units
| Code | Title | Units |
|---|---|---|
| CAPS-BIO 1012 | General Biology I (Lecture) | 3 |
| CAPS-BIO 1009 | General Biology I (Lab) | 1 |
| CAPS-BIO 1022 | General Biology II (Lecture) | 3 |
| CAPS-BIO 1019 | General Biology II (Lab) | 1 |
| CAPS-CRM 2000 | Fundamentals of Clinical Research Management I | 3 |
| CAPS-CRM 2001 | Fundamentals of Clinical Research Management II | 3 |
| CAPS-PHIL 2040 | Biomedical Ethics | 3 |
| CAPS-BIO 2200 | Anatomy and Physiology I | 4 |
| CAPS-BIO 2201 | Anatomy and Physiology II | 4 |
| CAPS-CRM 3010 | Introduction to Data & Information Management in Health Sciences | 3 |
| CAPS-CRM 3020 | Research Ethics and Regulatory Affairs | 3 |
| CAPS-CRM 3030 | The Business of Clinical Research | 3 |
| CAPS-CRM 3050 | Pharmacology for Clinical Research | 3 |
| CAPS-CRM 3051 | Practicum/Capstone for CRM | 3 |
| Total Units | 40 | |
Electives
Electives on the following topics are recommended:
- Clinical Research Management courses not on the "Required Courses" list above
- Psychology
- Leadership and Management
- Project Management
- Statistics
- Computer Programming
This program is offered fully online. Students entering the U.S. on an F-1 or J-1 Visa must enroll in a program full time. F-1 students are only permitted to enroll in one online course per semester and J-1 students may only enroll in non-credit online courses that do not count toward their degree program. WashU Continuing & Professional Studies (CAPS) cannot guarantee face-to-face enrollment options each semester of full time enrollment, therefore cannot issue an I-20 or DS 2019 to F-1 and J-1 students for this program. If you are an F-1 or J-1 student and wish to enroll in a CAPS program while here on a Visa, please contact our recruitment team to discuss your options for face-to-face program enrollment. F-1 and J-1 students should not enroll in online courses or programs without first consulting the university’s Office for International Students and Scholars (OISS).
CAPS-BIO 1012 General Biology I (Lecture)
First part of a two-term rigorous introduction to basic biological principles and concepts. The first term covers the molecular and cellular basis of life, bioenergetics, signal transduction, DNA and protein synthesis, and the function of whole organisms (physiology). Paired with weekly lab session/s. Laboratories include traditional wet labs as well as inquiry-based, online labs. Restricted to School of Continuing & Professional Studies (CAPS) students, others with CAPS permission.
Credit 3 units. UColl: NSC
Typical periods offered: Spring, Summer 2, Fall, Summer
CAPS-BIO 1019 General Biology II (Lab)
Second term (lab section) of a two-term sequence that provides a broad, but rigorous introduction to basic biological principles and concepts. The second term covers DNA technology and genomics, the genetic basis of development, the mechanisms of evolution, the evolutionary history of biological diversity, plant form and function, and ecology. Laboratories include traditional wet labs as well as inquiry-based on-line labs.
Credit 1 unit. UColl: NSC
Typical periods offered: Summer 4, Spring, Summer
CAPS-BIO 1022 General Biology II (Lecture)
Second term of a two-term sequence that provides a broad but rigorous introduction to basic biological principles and concepts. The second term covers DNA technology and genomics, the genetic basis of development, the mechanisms of evolution, the evolutionary history of biological diversity, plant form and function, and ecology. Paired with weekly lab/s. Laboratories include traditional wet labs as well as inquiry-based online labs.
Credit 3 units. UColl: NSC
Typical periods offered: Summer 4, Spring, Summer
CAPS-BIO 1009 General Biology I (Lab)
Lab section of gen Bio 1012. First part of a two-term introduction to basic biological principles and concepts. The first term covers the molecular and cellular basis of life, bioenergetics, signal transduction, DNA and protein synthesis, and the function of whole organisms (physiology). Laboratories include traditional wet labs as well as inquiry-based online labs. Restricted to students admitted to a School of Continuing & Professional Studies (CAPS) degree program. Others may register with instructor permission on a space-available basis.
Credit 1 unit. UColl: NSC
Typical periods offered: Spring, Summer 2, Fall, Summer
CAPS-BIO 2200 Anatomy and Physiology I
Anatomy and physiology is the study of inter-relationships between the structure and the function at gross and microscopic levels of the organization of the living body. The two-semester series will use the body systems to emphasize the anatomical terminology, cellular and tissue level of organization. Anatomy and physiology I includes the integumentary, skeletal, muscular, nervous and endocrine systems. The laboratory component reinforces topics and concepts covered in lectures.
Credit 4 units. UColl: NSC
Typical periods offered: Summer 4, Summer 3, Spring, Summer 2, Fall, Summer
CAPS-BIO 2201 Anatomy and Physiology II
Anatomy and physiology is the study of inter-relationships between the structure and the function at gross and microscopic levels of the organization of the living body. This two-semester course will use the body systems to emphasize the anatomical terminology, cellular and tissue level of organization. Anatomy and Physiology II includes the cardiovascular, respiratory, immune, digestion, urinary and reproductive systems. The laboratory component reinforces topics and concepts covered in lectures.
Credit 4 units. UColl: NSC
Typical periods offered: Summer 4, Summer 3, Spring, Summer 2, Fall, Summer
CAPS-PHIL 2040 Biomedical Ethics
Are doctors ever permitted to lie to their patients? Should physician-assisted suicide be legal? Should governments require their citizens to get vaccinated against common diseases? Is race-based medicine unjustified because race is a social construction? Should medical researchers be allowed to edit the human genome? Is there such a thing as a male or female brain? These are among the questions addressed in biomedical ethics. In this course we will critically examine, in light of contemporary moral disagreements and traditional ethical theories, some of the philosophical issues that arise out of medical practice and research in our society, including questions about specific policies and practices as well as broader questions about the implications of contemporary medicine, biology, and neuroscience. Topics may include euthanasia, genetic engineering, abortion, disability, medical malpractice, informed consent, the allocation of medical resources, patient autonomy, gender-affirming care, and health care as a human right. The course presupposes no background in philosophy.
Credit 3 units. UColl: ML
Typical periods offered: Summer 4, Summer 3, Summer 2, Summer 1, Summer, Spring, Fall
CAPS-CRM 2000 Fundamentals of Clinical Research Management I
This introductory course provides the basic foundation for clinical research. We examine the historical evolution of research, linking it to the current regulations and guidelines for good clinical practice. Course material includes research roles and responsibilities, institutional review boards, phases of drug development, the informed consent process, human subject protections, and an overview of study conduct.
Credit 3 units.
Typical periods offered: Fall
CAPS-CRM 2001 Fundamentals of Clinical Research Management II
This course focuses on the application of principles and theories covered in Fundamentals of Clinical Research Management I. Students will develop and complete documents for a specific assigned protocol. This will include completing institutional review board paperwork, writing an informed consent, developing source documents, and critiquing research articles.
Credit 3 units.
Typical periods offered: Spring
CAPS-CRM 3001 Internship in Clinical Research Management
Requires signed proposal and approval from CAPS
Credit 3 units.
Typical periods offered: Fall, Spring, Summer
CAPS-CRM 3006 Evidence-Based Decision Making
Policies can fail because of weak foundational support. Many times, there are no detailed strategic objectives and no clear and measurable success criteria, or these may not be aligned with strategic goals. This course is an introduction to developing policy. Using information about COVID-19 in St. Louis as a case study, this course highlights the intersection of culture; government; leadership; and social determinants such as sex, gender, and poverty. To develop the skills used to evaluate and solve problems, students will learn to critically examine the following: (1) the concept of health (broadly defined); and (2) how data are used to develop policies and programs for communities.
Credit 3 units. UColl: SSC
Typical periods offered: Fall, Summer 3, Spring
CAPS-CRM 3010 Introduction to Data & Information Management in Health Sciences
This course presents the basic principles for understanding the design, conduct, analysis, and endpoints of clinical trials. The class will review statistical terminology and explain trial design from a clinician's point of view, including theoretical and practical aspects of randomization, stratification, blinding, and single center versus multi-center trials. Additional topics include hypothesis formulation, commonly used research designs, statistical significance, confidence intervals, and statistical tests.
Credit 3 units.
Typical periods offered: Fall
CAPS-CRM 3020 Research Ethics and Regulatory Affairs
This course will provide an understanding of the ethical guidelines, issues, and challenges of conducting research on human subjects. We will explore issues such as conflicts of interest, genetic testing, limits of confidentiality, risk, and the distinction between compliance and ethics. As we learn about protecting research groups and interests and explaining rights and liabilities, we will study health care legislation and regulations, guidelines, contractual matters, and the complex regulatory framework that governs human subject research. Finally, we will learn to use an ethical problem-solving model in clinical research.
Credit 3 units. UColl: ML
Typical periods offered: Spring
CAPS-CRM 3026 Drug-Induced Diseases: Detection, Prevention, and Management
A drug-induced disease (DID) is the unintended effect of a drug taht results in mortality or morbidity with symptoms sufficient to prompt a patient to seek medical attention and/or require hospitalization. There have been great advances in drug therapy that have had tremendous beneficial impact on patient outcomes. However, the effects of drugs are not always beneficial; drugs are also capable of causing new diseases or exacerbating those that already exist. Some of these diseases are well known and transient (e.g., diarrhea, weight gain). Others, like liver disease and diabetes, are neither. This course will explore these issues in a novel, disease-specific way that will be accessible to a wide range of students: clinical research managers, medical students, nurses, pharmacists and other allied health professionals. The course will include weekly readings from the textbook or other sources. Regular group discussions will be important, addressing how this new knowledge can be applied to students' professional or personal practices.
Credit 3 units.
Typical periods offered: Fall, Spring
CAPS-CRM 3030 The Business of Clinical Research
An overview of the business elements of clinical research, this course covers drug and device development, the regulatory environment, finance, corporate structures, and the clinical trials office. Students will consider stakeholders including pharmaceutical and device industries, academic and private research centers, government agencies such as the National Institutes of Health, nonprofit agencies and a variety of other organizations such as American Diabetes Association and the National Cancer Institute. They also will study local, state, and federal regulations, as well as international and global issues that impact the business of clinical research.
Credit 3 units.
Typical periods offered: Fall, Spring
CAPS-CRM 3050 Pharmacology for Clinical Research
This course presents the basic principles of pharmacology and their application to clinical research management to help ensure safe and effective management of drug trials. We will study the foundations of pharmacology, including the principles of drug absorption, distribution, metabolism and excretion, drug binding sites and interactions, and drug development. We also will examine pharmacological problems with special populations, and the emergent area of pharmacogenetics. In the second half of the course we will review important drug classes, with an emphasis on understanding Investigator's Brochures, including drug action and place in therapy, pharmacology, toxicity, chemical properties, and kinetics.
Credit 3 units.
Typical periods offered: Fall, Spring
CAPS-CRM 3051 Practicum/Capstone for CRM
This course provides student-specific guidance and experience in a clinical research environment. Students will engage in practical experiences in a field and therapeutic area of their choice, or, if desired, get exposure to diverse clinical research settings. The practicum will take place in departments within WashU outpatient research settings and pharmaceutical and device industry settings. Students already working in a clinical research environment will have the option of completing a research project with instructor approval or a hybrid between the practicum and the capstone in order to fit their goals. Student must have completed all other courses for the undergraduate degree or undergraduate certificate in the Clinical Research Management Program. May be concurrent with final course.
Credit 3 units.
Typical periods offered: Summer 3, Spring, Fall, Summer
CAPS-CRM 3350 Introduction to Project Management in Clinical Research
This course aims to explore basic concepts of project management with direct application to clinical research. Students will better understand criteria defining a project and product (versus operations), roles and responsibilities of a project manager, various methodologies (e.g. agile, waterfall, etc.), and planning tools (e.g. Microsoft Project, Jira, Teams). Student experiences in clinical research will be integrated into course discussions to explore application of project management skills and practice important team-building skills (e.g. effective meeting principles). Additionally, the course will incorporate a variety of learning resources from the Project Management Institute (PMI), LinkedIn, and professional research organizations (e.g. ACRP) into class discussions and project assignments. One or more (modified) research protocols will be used for hands-on experience applying project management strategies.
Credit 3 units.
Typical periods offered: Summer 3, Spring, Fall, Summer
CAPS-CRM 4999 Independent Study in Clinical Research Management
Requires completed proposal form, permission from CAPS.
Credit 3 units.
Typical periods offered: Fall Intersession, Summer 3, Spring, Summer Intersession, Spring Intersession, Fall