Dec 02, 2022
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The M.S. in Clinical Research Administration program is designed to provide students with the knowledge and skills required for effective clinical research administration and management. This includes a detailed understanding of the regulatory environment and the following specialized, targeted skills:
- Management of clinical protocols
- Scientific protocol development
- Ethical and regulatory standards
- Budget management
- FDA regulatory compliance
- Publication in specific drug class and peer-reviewed journals
- R&D/Marketing interface
- The overall management and training of clinical research personnel
Clinical research administrator positions are found in a variety of organizations, including pharmaceutical, consumer products, healthcare, biotech, and medical device companies, as well as contract clinical research organizations (CROs), government/regulatory organizations, and university research settings.
This program is designed for students who have a broad social science or health background. Specific emphasis is placed on providing state-of-the-art understanding of clinical research execution and management through analysis of the day-to-day operations in clinical testing activities. A culminating practicum provides field experiences in a clinical trial setting.
At the end of this program, students will be able to:
- Describe basic research strategies, settings, methods, and goals of clinical research, including all aspects of the preclinical and clinical phases of clinical trials.
- Critique the advantages and disadvantages of various study protocol designs as related to the test product and anticipated endpoints of the clinical research process.
- Critically appraise published clinical research and interpretation of new research in the context of existing knowledge and global trends/issues.
- Demonstrate an understanding of the interdependence of the different roles in the clinical research team, including the alliance of subjects, regulatory agencies, sponsors, and sites.
- Identify ethical, legal, regulatory, and financial considerations that impact clinical trials.
- Apply the essentials of Good Clinical Practice (GCP) in their professional practice.
- Demonstrate an understanding of how the evolution of the safety and efficacy data in drug, biological, and device developments from preclinical testing through to registration and post-marketing surveillance impact product development.
- Demonstrate an understanding of the basic physiological and epidemiological causes and correlations of disease as they relate to clinical trial investigations.
- 33 total semester credit hours
- Core courses (30 sem. cr.)
- Capstone (3 sem. cr.)
Each course is 8 weeks in length, and there are two consecutive courses per semester. The program is offered in a prescribed sequence.
Core Course (30 sem. cr.)
Capstone Course (3 sem. cr.)
Students in the M.S. in Clinical Research Administration program may elect to earn a practicum experience by adding an additional course, CLRA 6550 - Practicum, to their program of study. Students should contact the Academic Advising Team at any point in their program before completing CLRA 6175 - Biostatistics to request the addition of CLRA 6550 - Practicum to their program of study.
The M.S. in Clinical Research Administration optional practicum is designed to provide students who have finished their coursework with the opportunity to synthesize knowledge, to develop competence in professional practice, to apply knowledge to the solution of clinical research administration problems, and to develop a respect for and a commitment to continued professional knowledge.
The required hours of agency service may take place only during registration in the appropriate seminar. All work hours must occur on or after the official start date of the approved semester and may not go beyond the end date of the semester. Students who cannot complete the practicum hours in one semester must register for the seminar until all field hours are completed.
Students must have completed the first five semesters of required coursework to begin the practicum and must be in good academic standing. Students are advised to begin seeking a practicum placement as early as possible, but no later than two terms before they plan to begin the practicum. Details about the practicum, the required forms, the approval process, and important practicum application deadlines are available through students’ myWalden university portal.
Walden is committed to providing the information you need to make an informed decision about where you pursue your education. Click here to find detailed information for the M.S. in Clinical Research Administration program relating to the types of occupations this program may lead to, completion rate, program costs, and median loan debt of students who have graduated from this program.