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Applied Clinical Research Graduate Program (ACR)

Offered through the Academic Center for Applied Education in the MedTech Industry
College of Science and Engineering, St. Cloud State University
145 Wick Science Building
Phone: 320.308.2167
Fax: 320.308.5124
Email: acr@stcloudstate.edu
Web: http://www.msacr.com

Director/Graduate Coordinator: Patricia E. Feulner
Department Chair: Dr. David DeGroote
Department Secretary: Julie Nienaber
Graduate Faculty: http://www.stcloudstate.edu/acr/faculty.asp

The Program

The Master of Science in Applied Clinical Research provides students with  the necessary tools and competencies needed to design, conduct and evaluate human clinical trials for the medical device industry. The program covers basic human anatomy, physiology and pathophysiology, as well as guidance from regulatory agencies in the US and across the world about design, conduct and evaluations of human clinical trials using appropriate statistical design protocols. The program provides "real world" examples and projects to grain competency in the logistics and risk management of human trials and assessing the risk and safety concerns. Graduates will be able to translate complex technical clinical results to the general population and accelerate their advancement to a leadership position in a medical device company/consulting agency.

The Profession

The clinical research professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure valid and ethical experimental design protocols are stringently adhere to federal and international medical device regulations for safety and efficacy. In successful medical device companies, clinical research professionals provide the scientific validation of the medical device under stringent scientific and ethical standards. The clinical professional team provides the "proof of concept" to a research hypothesis.

The clinical research professional requires versatile individuals with excellent communications skills and a broad knowledge of: human biology, statistical methods, experimental design, state, federal and international regulation, planning and logistics and risk management. As more diseases are described and the pathology elucidated more devices and biological products are being developed to mitigate these maladies. Testing these products in an ethical manner to ensure safety and efficacy requires a growing cadre of clinical professionals to meet the medical innovation that is evolving every day in the medical technology industry. This program will provide students with the requisite skills to be part of this vibrant and critical contribution to human health.

Program Overview

The graduate program provides the means to develop the essential understanding and competencies to work as a clinical research professional in medical technology industry or consulting organizations. It provides experience and development competencies in:

• Human disease and medical applications to avert.
• Design and conduct of ethical and efficacious human clinical trial.
• Regulatory compliance for human clinical trials.
• Role of Clinical Research professionals.

Admission Requirements Specific to the Program

• For admission consideration to the program, a candidate must first meet the minimum GPA admission requirements of the School of Graduate Studies at St. Cloud State University.
• The GRE is not required.
• An undergraduate degree in science, engineering, math, statistics, nursing or other appropriate and relevant area is recommended for admission candidacy.
• Additionally, three years of post undergraduate working experience is recommended. However, recent undergraduates may be considered for admission.
• The GRE is not required.
• Admission decisions are made throughout the year as completed application files are received . Students may be admitted for fall, spring and summer terms.
• The director and selected instructors from the program will review applications to ensure each candidates' qualifications.

To Apply

The following Web sites provides admission requirements and a checklist for graduate admissions: http://www.stcloudstate.edu/gradadmissions/

Application Deadlines Specific to the Program

Domestic admission application deadlines

Degree and Plan Offered

Master of Science (non-thesis) Plan B, 34 credits.

Program Location and Time

The program is offered at the Twin Cities Graduate Center located in Maple Grove, Minnesota. For map/location, go online to St. Cloud State University: Twin Cities Graduate Center (http://www.stcloudstate.edu/tcgraduatecenter/)

• Computer lab, classrooms, and breakout areas are available for this program.
• Students will have full access to electronic resources via a SCSU HuskyNet account, and instruction will be provided by course management software, currently D2L.

Length of Program - Measured by Semesters

Part-time student: 6 semesters over 2 years. Course descriptions listed below:

Tuition costs: http://www.stcloudstate.edu/acr/apply.asp

Master of Science in Applied Clinical Research — 34 credits

Foundational Courses for Clinical Research

ACR 620. Applied Anatomy, Physiology, & Pathophysiology, 4
ACR 622. Lifecycle of the Clinical Product, 2
ACR 624. Biostatistics for Clinical Trials, 4
ACR 626. Evidence Based Medicine, 3
ACR 628. Regulatory Compliance & Research Ethics, 3

Clinical Trial Planning & Execution

ACR 630. Clinical Study Design & Planning, 3
ACR 632. Clinical Study Operations & Execution, 3
ACR 634. Clinical Risk Management & Safety, 3
ACR 636. Communications & Reporting for Clinical Trials, 3

Clinical Trial Leadership Development

ACR 640. Clinical Research Leadership, 3
ACR 696. Clinical Culminating Experience, 3

If you have further questions, please contact the College of Science and Engineering at 320.308.2192 or arc@stcloudstate.edu