Certificate of Study in Clinical Research

Certificate Level: Graduate
Admissions Requirements: Bachelor's degree or higher
Certificate Type: Graduate
Number of Credits to Completion: 15.0
Instructional Delivery: Online
Calendar Type: Semester
Maximum Time Frame: 3 years
Financial Aid Eligibility: Not aid eligible
Gainful Employment Statistics

This part-time certificate program is a valuable professional resource for today's busy physicians, physician assistants, nurses, clinical fellows, research coordinators, and other individuals working in the clinical arena who want in-depth exposure to the skills and knowledge needed in the evolving clinical research field without having to commit to an entire master’s program. All courses are conducted online to accommodate the needs of working professionals.

This program requires the successful completion of five graduate courses. Credits earned in the certificate program are recognized towards the Master of Science in Clinical Research Organization and Management.

ADDITIONAL INFORMATION

Sara Perkel, MBA
Director, Graduate Programs in Clinical Research
sara.perkel@drexelmed.edu
215-762-3812

Visit the Drexel University Online site for additional program information and to apply to the certificate program.

15.0 semester credits

Requirements
CR 515SIntro to Clinical Trials3.0
CR 545SPharmaceutical Law3.0
CR 612SFundamentals of Compliance3.0
Electives
Select two of the following:6.0
Contemporary Issues in Human Research Protection
Principles and Practice of Pharmacovigilance
Scientific Wriring and Medical Literature
INNOVATIVE PRODUCT DEVELOPMENT
Biotech/Research
Health Policy and Economics
Total Credits15.0

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: COM School of Biomedical Sciences & Professional Studies
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 Writing 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.

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.

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.

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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