Master of Science in Clinical Research Organization and Management
About the Program
Master of Science: 36.0 semester credits
The Master of Science in Clinical Research Organization and Management is an online program, designed both for individuals already trained in the area of clinical sciences, as well as for others who desire focused training in the proper conduct of clinical research.
The Master of Science in Clinical Research Organization and Management offers students a rigorous graduate education taught by leaders from the pharmaceutical, biotechnology and medical device industries, as well as from academic research centers.
The program provides online courses that include scientific rationale related to the design and analysis of clinical trials, biostatistics, ethics-based reasoning for the conduct of research, clinical trial management processes, and federal regulatory rules and policies essential to the development of a broadly-educated and well-prepared professional in clinical research and new therapeutic product investigation.
The program is designed so that graduates will be able to:
- Successfully apply the framework and philosophies of research to the management of clinical trials, employing quality principles of current good clinical practice to produce valid and useful data;
- Ensure that sound ethical principles and values are always recognized and upheld in research involving a human population;
- Use current statistical knowledge and methods in the design, implementation, conduct, and assessment of clinical trial management; and
- Understand the scientific and clinical research literature to effectively interpret the results of clinical research, thereby enhancing the decision-making process.
Students have the ability to custom-tailor their learning by enrolling in programs and courses in a variety of medical topics.
For more information about the program, visit the Master of Science in Clinical Research Organization and Management page on the Drexel e-Learning site.
For information about applying to the program, visit the Drexel University Online Admissions Criteria web page.
Degree Requirements
The Master of Science in Clinical Research Organization and Management consists of 12 courses. Any courses offered by the Clinical Research Organization Management program may be applied to fulfill the requirements of this major.
The program is organized into five areas of study devoted to clinical research and related administrative and regulatory issues. Students can take courses within their preferred area of study, a cross-section of courses within other areas of study, or any other CR courses being offered.
| New Product Research and Development | ||
| CR 513S | Pharmaceutical R&D: Business Process and Infromation Flow | 3.0 |
| CR 514S | World Wide Regulatory Submissions | 3.0 |
| CR 515S | Intro to Clinical Trials | 3.0 |
| CR 609S | INNOVATIVE PRODUCT DEVELOPMENT | 3.0 |
| CR 620S | Biotech/Research | 3.0 |
| Regulatory Compliance, Ethics and Law | ||
| CR 505S | Ethical Issues in Research | 3.0 |
| CR 511S | The History of Misconduct in Biomedical Research | 3.0 |
| CR 535S | Current Federal Regulatory Issues in Biomedical Research | 3.0 |
| CR 555S | COMPLIANCE & MONITORING ISSUES | 3.0 |
| CR 565S | Contemporary Issues in Human Research Protection | 3.0 |
| CR 633S | Quaility Assurance Audits | 3.0 |
| CR 612S | Fundamentals of Compliance | 3.0 |
| CR 545S | PHARMACEUTICAL LAW | 3.0 |
| Biostatistics and Data Management | ||
| CR 500S | Epidemiology | 3.0 |
| CR 520S | Applications of Clinical Research Biostatistics | 3.0 |
| CR 560S | SPECIAL TOPICS | 3.0 |
| CR 600S | DESIGNING THE CLINICAL TRIAL | 3.0 |
| Clinical Research Management and Safety Surveillance | ||
| CR 512S | Fundamentals of Academic Research Adminstration | 3.0 |
| CR 525S | Scientific Writing & Med Lit | 3.0 |
| CR 625S | Health Policy and Economics | 3.0 |
| New Therapeutic Product Business and Strategic Planning | ||
| CR 530S | TECH TRANSFER | 3.0 |
| CR 635S | STRATEGIC PLANNING | 3.0 |
| CR 550S | Leadership Skills | 3.0 |
Courses
CR 500S Epidemiology 3.0 Credits
Epidemiology is at the core of research professions as it is the study of the distribution, determinants, and the course of health related events in populations, and the efficacy and effectiveness of prevention and intervention strategies.
Repeat Status: Can be repeated 2 times for 6 credits
CR 501S Emerging Trends in Medical Device History 3.0 Credits
The goal of this course is to focus on the various trends that impact the research and development process inherent in the medical device industry. Case studies representing several therapeutic categories will be discussed from a business, medical scientific, ethical, regulatory and bio-medical engineering perspective.
CR 505S Ethical Issues in Research 3.0 Credits
Students explore ethical issues to sound clinical research, review the foundations of regulations for clinical investigations, and to better understand the operational imperatives of Good Clinical Practices.
Repeat Status: Not repeatable for credit
CR 510S Sponsored Projects Finance 3.0 Credits
The study of managing and monitoring external funding sources for research projects. Topics include: rules and regulations, proposal preparation and submission, cost accounting standards, salaries and benefits of staff, direct and indirect costs, the costing of equipment and facility use.
Repeat Status: Can be repeated 2 times for NaN credits
CR 511S The History of Misconduct in Biomedical Research 3.0 Credits
College/Department: College of Medicine
Repeat Status: Can be repeated 1 times for NaN credits
CR 512S Fundamentals of Academic Research Adminstration 3.0 Credits
College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated 1 times for 3 credits
CR 513S Pharmaceutical R&D: Business Process and Information Flow 3.0 Credits
College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated 1 times for NaN credits
CR 514S World Wide Regulatory Submissions 3.0 Credits
College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated 1 times for NaN credits
CR 515S Intro to Clinical Trials 3.0 Credits
This course introduces regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, FDA -all those parties intimately involved in clinical research. Information and exercises are designed to reinforce the elements of Good Clinical Practices.
Repeat Status: Not repeatable for credit
CR 520S Applications of Clinical Research Biostatistics 3.0 Credits
Examines role of the statistician in clinical research. Course includes a discussion of the language of statistics to facilitate communication with the clinical research project team, basic methods of describing data, fundamentals of probability, simple models and methods of parameter estimation and statistical software packages for reporting data.
CR 525S Scientific Writing & Med Lit 3.0 Credits
This course teaches the medical professional the ability to read for understanding, and evaluate validity of information a medical or scientific paper. In addition, the student learns how to recognize various types of medical literature and the basics of how to perform a review of the medical literature.
Repeat Status: Can be repeated 2 times for 6 credits
CR 530S TECH TRANSFER 3.0 Credits
The study of leveraging research capabilities with the marketplace and communicating research results for public benefit. Topics to include: the identification, management, development and commercialization of marketable research and technologies. Additional topics include patents and licensing.
Repeat Status: Can be repeated 2 times for NaN credits
CR 535S Current Federal Regulatory Issues in Biomedical Research 3.0 Credits
College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated 1 times for 3 credits
CR 545S PHARMACEUTICAL LAW 3.0 Credits
Presents principles and practices of the Federal Food, Drug and Cosmetic Act governing the research and development of pharmaceuticals and biologics for both humans and animals including an analysis of legal and social constructs affecting industry and the academic clinical investigator with emphasis on FDA enforcement actions.
Repeat Status: Not repeatable for credit
CR 550S Leadership Skills 3.0 Credits
This course is an in-depth analysis of specific human capital, organizational behavior and project management issues facing research facilities as they pertain to larger, integrated organizations. Selected topics include: high impact communications, negotiating, motivation and recognition.
Repeat Status: Can be repeated 2 times for 6 credits
CR 555S COMPLIANCE & MONITORING ISSUES 3.0 Credits
This course focuses on measuring and improving clinical trial performance as a means of saving time and money, while ensuring quality health care, as well as offering to patients both safe and effective therapeutic products. Students are required to develop milestone efficiencies through the use of process-performance data.
Repeat Status: Not repeatable for credit
CR 560S SPECIAL TOPICS 3.0 Credits
Individualizes enhancement to core curriculum in research. Students will determine which extracurricular lectures and events they will attend based on their interest and career intent.
Repeat Status: Can be repeated 2 times for NaN credits
CR 565S Contemporary Issues in Human Research Protection 3.0 Credits
College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated 1 times for 3 credits
CR 570S Principles and Practice of Pharmacovigilance 3.0 Credits
This course is an introduction to the ethical, clinical, and regulatory complexities of medication safety and matters thinking skills for improving the quality and effectiveness of drug safety monitoring for both the pharmaceutical industry and its impact on the public.
Repeat Status: Not repeatable for credit
CR 600S Designing the Clinical Trial 3.0 Credits
Designers and ethical, clinical, strategic issues surrounding clinical drug research are the focus of this course. Topics include design of trials for Phases one though four, an overview of the statistical component of a clinical trial, monitoring of the trial, and managing clinical data.
Repeat Status: Not repeatable for credit
Prerequisites: CR 515S [Min Grade: C]
CR 609S INNOVATIVE PRODUCT DEVELOPMENT 3.0 Credits
This comprehensive course provides a solid foundation in new therapeutic product research and development for the subsequent courses in the CROM program. This course focuses on the process of drug and medical device development from early research, discovery, and product formulation, through the federal requirements form proving safety and efficacy. May be repeated twice for credit.
Repeat Status: Not repeatable for credit
CR 612S Fundamentals of Compliance 3.0 Credits
The study of the federal bodies and regulations that govern research. Topics include: the rules and regulations surrounding HIPAA and how it affects research on human subjects, the history and current role of the FDA, IACUC, and the IRB within the research arena. May be repeated twice for credit.
Repeat Status: Can be repeated 0 times for 6 credits
CR 614S Pharmacotherapy in New Drug R&D 3.0 Credits
Through the use of selected readings, case studies available from the FDA, and Blackboard discussions, this course will integrate preclinical/clinical research pharmaceutical operations along with federal regulatory approval principles, emphasizing the essentials of pharmacokinetic /pharmacodynamic activity of medications as the sound basis for understanding the clinical application of drug therapy with specific populations.
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.
CR 616S Intro to Therapeutic Products 3.0 Credits
This course is designed to provide an overview of the diverse marketing and advertising practices and strategies of the pharmaceutical industry and their impact on the professional healthcare infrastructure, as well as on the healthcare recipient population. Students will be encouraged to develop skills to crucially evaluate the marketing techniques of the pharmaceutical industry.
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.
CR 617S Informatics in Pharm Res & Development 3.0 Credits
Using a combination of printed materials, case studies, literature reviews, and on-line discussions, this course will cover past and present contributions of computer applications in pharmaceutical research and development. In addition, the student will be challenged to portend where technological advances may prove to be strategically beneficial in the future.
Repeat Status: Not repeatable for credit
Restrictions: Can enroll if major is CR or major is CROM.
CR 620S Biotech/Research 3.0 Credits
The study of the history, use and progression of biological techniques developed through basic research and now how it is applied to research and product development.
Repeat Status: Can be repeated 0 times for NaN credits
CR 625S Health Policy and Economics 3.0 Credits
The study of the development, analysis and communication of economic data in the context of clinical research. May be repeated twice for credit.
Repeat Status: Can be repeated 2 times for 6 credits
CR 630S Trans Research 3.0 Credits
The study of the conversion of research into information, resources or tools that can be used by the public to improve overall health and well-being. Students will learn the management and applicability issues in converting basic research discoveries and innovative ideas into clinical trials that lead to better treatment.
CR 633S Quaility Assurance Audits 3.0 Credits
This course provides the student with an in-depth knowledge of compliance and quality assurance issues as well as the related regulations inherent in the drug development process. Students develop auditing plans and strategies for conducting compliance inspections.
Repeat Status: Not repeatable for credit
CR 635S STRATEGIC PLANNING 3.0 Credits
This course introduces the student to the project management and planning process. Topics include: project communications, leadership, objectives, scope, success criteria, procurement, cost estimating, control mechanisms, developing mission statements and devising strategies that turn vision into reality. May be repeated twice for credit.
Repeat Status: Can be repeated 2 times for 6 credits
CR 999S Special Topics 1.0-3.0 Credit
College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Can be repeated multiple times for credit
