Master of Science in Clinical Research Organization and Management

Master of Science: 36.0 semester credits

About the Program

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 program 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, epidemiology and biostatistics, ethics-based reasoning for the conduct of research, clinical trial management and monitoring 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 work with advisors to customize their course plans to meet their career goals.

Program Delivery Options

All Clinical Research (CR) courses are offered solely online.  Visit the Drexel University Online site for details.

Additional Information

 

For more information about the program, visit the Master of Science in Clinical Research Organization and Management page on the Drexel University Online 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 program consists of 12 courses (36.0 credits). Any courses offered by the Clinical Research Organization Management program may be applied to fulfill the requirements of this major. No master's thesis is required.

The program is organized into five areas of study devoted to clinical research and related administrative and regulatory issues. Students may take courses within their preferred area of study, a cross-section of courses within other areas of study, or any other Clinical Research (CR) courses being offered.

New Product Research and Development
CR 513SPharmaceutical R&D: Business Process and Information Flow3.0
CR 514SWorld Wide Regulatory Submissions3.0
CR 515SIntro to Clinical Trials3.0
CR 609SINNOVATIVE PRODUCT DEVELOPMENT3.0
CR 620SBiotech/Research3.0
Regulatory Compliance, Ethics and Law
CR 505SEthical Issues in Research3.0
CR 511SThe History of Misconduct in Biomedical Research3.0
CR 535SCurrent Federal Regulatory Issues in Biomedical Research3.0
CR 555SCOMPLIANCE & MONITORING ISSUES3.0
CR 565SContemporary Issues in Human Research Protection3.0
CR 633SQuaility Assurance Audits3.0
CR 612SFundamentals of Compliance3.0
CR 545SPHARMACEUTICAL LAW3.0
Biostatistics and Data Management
CR 500SEpidemiology3.0
CR 520SApplications of Clinical Research Biostatistics3.0
CR 560SSPECIAL TOPICS3.0
CR 600SDesigning the Clinical Trial3.0
Clinical Research Management and Safety Surveillance
CR 512SFundamentals of Academic Research Adminstration3.0
CR 525SScientific Writing & Med Lit3.0
CR 625SHealth Policy and Economics3.0
New Therapeutic Product Business and Strategic Planning
CR 530STECH TRANSFER3.0
CR 635SSTRATEGIC PLANNING3.0
CR 550SLeadership Skills3.0

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 511S The History of Misconduct in Biomedical Research 3.0 Credits

College/Department: College of Medicine
Repeat Status: Not repeatable for credit

CR 512S Fundamentals of Academic Research Administration 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 513S Pharmaceutical R&D: Business Process and Information Flow 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 514S World Wide Regulatory Submissions 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 525S Scientific Wriring and Medical Literature 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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

CR 535S Current Federal Regulatory Issues in Biomedical Research 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: College of Medicine
Repeat Status: Not repeatable for credit

CR 565S Contemporary Issues in Human Research Protection 3.0 Credits

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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.

College/Department: COM School of Biomedical Sciences & Professional Studies

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.

College/Department: COM School of Biomedical Sciences & Professional Studies
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.

College/Department: COM School of Biomedical Sciences & Professional Studies
Repeat Status: Not repeatable for credit

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

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