Aug 07, 2020  
2011-2012 Graduate Catalogue 
    
2011-2012 Graduate Catalogue Archived Catalogue

Clinical Research and Product Development, M.S.


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Graduate Coordinator: Dr. Julie Taylor

The UNCW Clinical Research Program offers a Master of Science degree in Clinical Research and Product Development with two concentrations: Clinical Research Management, and Regulatory Affairs and Compliance. The M.S. in Clinical Research and Product Development provides a didactic and rigorous curriculum that prepares individuals to participate in the science and business of developing health care products and protocols, from discovery to market and human utilization. Particular emphasis is placed on clinical research as it pertains to biopharmaceutical and device development. The degree is offered entirely online providing students with the flexibility to pursue the degree from any location with internet access.

Admission Requirements


Students desiring admission into the M.S. in Clinical Research and Product Development must seek admission to the UNCW Graduate School. All applicants must complete the Graduate Record Examination general test (GRE-Verbal, Quantitative, and Analytical Writing) or the Miller Analogies Test (MAT). Standardized test scores more than five years old at the time of application will not be considered. In addition, students who are taking, or have taken, graduate work elsewhere must be in good standing at that institution to be eligible to take graduate work at UNCW.

Additional admission requirements include:

  • Eligible applicants for the MS program are individuals who possess a minimum of a B.A. or a B.S. degree, preferably in a life science or health care discipline from a regionally accredited program.
  • Strong academic record with an undergraduate GPA of 3.0 or better.
  • Computer competency.
  • Successful completion of a college-level statistics course.
  • Six semester hours of graduate level transferred credit may be accepted upon approval.
  • A comprehensive invited interview may be requested.
  • Additional items as needed.

Applicants must have access to a computer capable of supporting electronic mail, a web browser, a word processing program and multi-media presentations. In addition, applicants must demonstrate ability to use these computer applications.

Admission to the UNCW Graduate School requires the following documents:

  1. A completed UNCW Graduate School application
  2. Official transcripts of all college work
  3. Official scores on the Graduate Record Examination (GRE) or Miller Analogies Test (MAT)
  4. A completed Written Narrative for the M.S. in Clinical Research and Product Development form, not to exceed two (2) pages, double spaced, with one-inch margins, and at least a 10 pitch font
  5. A completed Demographic Form for the M.S. in Clinical Research and Product Development
  6. Current resume or curriculum vitae
  7. Three recommendations (one from a former faculty member and one form a current or former employer, preferred)

Program Student Learning Outcomes


Upon completion of the Master‘s curriculum, the new graduate will be able to:

  1. Demonstrate competency in biopharmaceutical clinical trial research designs and regulatory affairs management to meet the health and medical needs of current and future biopharmaceutical product consumers.
  2. Evaluate critical domestic and global regulatory and health care issues that challenge and influence biopharmaceutical product development.
  3. Effectively assess and manage ethical clinical trial programs and biopharmaceutical development projects.
  4. Forecast the resources necessary for developing and managing biopharmaceutical clinical research grants and trials as required and regulated by global regulatory agencies.
  5. Demonstrate competencies in evaluating clinical research data and communicating results.
  6. Manage innovative biopharmaceutical/biotechnology products through the discovery processes and into the clinical trial phases via identifying research questions and testable hypotheses.
  7. Demonstrate advanced critical thinking skills necessary to enhance employment opportunities or advance within the biopharmaceutical industry.
  8. Effectively communicate and collaborate with health care providers and regulatory agencies to develop culturally diverse domestic and global strategies for biopharmaceutical product approvals.

Degree Requirements


Students must choose and declare their area of concentration for the degree in either Clinical Research Management, or Regulatory Affairs and Compliance. The total number of credit hours for the M.S. in Clinical Research and Product Development is 36 hours. Students are required to complete 15 credit hours of core courses (i.e., 5 courses), 12 credit hours (i.e., 4 courses) within the students‘ chosen concentrations, 6 credit hours (i.e., 2 courses) of elective credits, and 3 to 6 credit hours for the master‘s project/thesis.

Degree Options


Note

* Indicates required courses

Additional Information


Students must maintain a 3.0 GPA while enrolled in the M.S. in Biopharmaceutical Clinical Research degree. Six semester hours of graduate level transferred credit may be accepted upon approval.

The residency requirement follows those requirements as defined in the UNCW Graduate Coordinator‘s Reference Manual.

Research Requirements


The M.S. in Clinical Research and Product Development requires a research project. If the project question and hypothesis are of original research, then a thesis will be advised in lieu of a project. Students may enroll in a thesis class (3 credits) after completing all of the required core courses, concentration courses, and elective courses (33 credits), or while the last two courses are in progress (27 credits), as long as the last two courses are not core courses. Students requiring additional time to complete their theses may enroll in the thesis class in subsequent semesters. The M.S. in Clinical Research and Product Development must be completed within 6 years of acceptance and initial enrolment in the program.

M.S. in Clinical Research and Product Development Full-Time Program of Study


Semester 1

 Courses to be determined by Academic Advisor.

Total: TBA Hours

Semester 2

 Courses to be determined by Academic Advisor.

Total: TBA Hours

Semester 3

 Courses to be determined by Academic Advisor.

Total: TBA Hours

Semester 4

 Courses to be determined by Academic Advisor.
 

Total: TBA Hours

Note

(*) indicates required courses

Total: 36 Hours

Core Courses - 15
Concentration Courses - 12
Designated Program Electives - 6
Project/Thesis - 3

M.S. in Clinical Research and Product Development Part-Time Program of Study


Semester 1

 Courses to be determined by Academic Advisor.

Total: TBA Hours

Semester 2

 Courses to be determined by Academic Advisor.

Total: TBA Hours

Semester 3

 Courses to be determined by Academic Advisor.
 

Total: TBA Hours

Semester 4

 Courses to be determined by Academic Advisor.
 

Total: TBA Hours

Semester 5

 Courses to be determined by Academic Advisor.
 

Total: TBA Hours

Semester 6

 Courses to be determined by Academic Advisor.
 

Total: TBA Hours

Note

(*) indicates required courses

Total: 36 Hours

Core Courses - 15
Concentration Courses - 12
Designated Program Electives - 6
Project/Thesis - 3

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