Overview
The Master of Science in Clinical Research Management is designed to equip students, particularly those in nursing, with comprehensive knowledge in the field of clinical research. This program focuses on essential areas including protocol development, regulatory compliance, study design, data collection and management, statistical analysis, and the effective communication of research findings. Through a curriculum aligned with industry standards, students are prepared for professional certification in clinical research.
Emphasizing both theory and practical skills, the program trains clinical research professionals to work collaboratively with principal investigators and research teams. Students learn to oversee and coordinate studies, manage regulatory and ethical requirements, ensure participant safety, and uphold high standards of Good Clinical Practice (GCP).
Graduates of the program will be well-prepared to take on leadership roles in the clinical research field, contributing to the advancement of nursing and health sciences.
Admission Requirements
- Bachelor’s degree in nursing from a regionally accredited institution.
- Bachelor’s degree in other relevant science fields may be considered.
- Official transcripts for each institution attended must be mailed from the issuing institution’s Registrar. The University of Miami cannot process transcripts that are stamped “Issued to Student.”
- Applicants are required to list all institutions attended in, even if no degree was awarded.
- Applicants with international transcripts should refer to the “Additional Requirements for International Transcripts” section below. International degrees must be equivalent to those in the U.S.
- Minimum cumulative undergraduate GPA of 3.0
- Introductory statistics course
- Minimum 1 year work experience related to human subject research.
- Current CV/resume
- The CV/resume should include work and volunteer activities, licensures and other certifications, awards, professional organizations, and academic experiences.
- Two letters of recommendation
- At least one reference from an academic source.
- Complete the “References” section to request electronic recommendations.
- Statement of purpose
- Discuss the reasons for applying to the MS CRM program at the University of Miami and how it fits into personal, educational, and professional goals.
Curriculum Requirements
| Code | Title | Credit Hours |
|---|---|---|
| HCS 607 | Introduction to Clinical Research (NEW COURSE) | 3 |
| HCS 616 | Roles and Responsibilities (NEW COURSE) | 3 |
| HCS 617 | Regulatory Affairs (NEW COURSE) | 3 |
| HCS 618 | Recruitment and Retention of Participants (NEW COURSE) | 3 |
| HCS 619 | IRB and Responsible Conduct (NEW COURSE) | 3 |
| HCS 624 | Scientific Writing (NEW COURSE) | 3 |
| HCS 625 | Database and Data Management (NEW COURSE) | 3 |
| HCS 626 | Quality Assurance (NEW COURSE) | 3 |
| HCS 627 | Data Analysis (NEW COURSE) | 3 |
| HCS 630 | Immersion Practicum (NEW COURSE) | 3 |
| Total Credit Hours | 30 | |
Sample Plan of Study
| Year One | ||
|---|---|---|
| Spring | Credit Hours | |
| HCS 607 | Introduction to Clinical Research 1 | 3 |
| HCS 616 | Roles and Responsibilities 1 | 3 |
| HCS 618 | Recruitment and Retention of Participants 2 | 3 |
| HCS 619 | IRB and Responsible Conduct 2 | 3 |
| Credit Hours | 12 | |
| Summer | ||
| HCS 617 | Regulatory Affairs | 3 |
| HCS 626 | Quality Assurance | 3 |
| Credit Hours | 6 | |
| Year Two | ||
| Fall | ||
| HCS 625 | Database and Data Management 3 | 3 |
| HCS 627 | Data Analysis 3 | 3 |
| HCS 624 | Scientific Writing 4 | 3 |
| HCS 630 | Immersion Practicum 4 | 3 |
| Credit Hours | 12 | |
| Total Credit Hours | 30 | |
A Session is 10 weeks in length. Courses are offered two at a time for each session.
- 1
Courses HCS 607 and HCS 616 are taken together in Spring Session I.
- 2
Courses HCS 618 and HCS 619 are taken together in Spring Session II.
- 3
Courses HCS 625 and HCS 627 are taken together in Fall Session I.
- 4
Courses HCS 624 and HCS 630 are taken together in Fall Session II.
Mission
The mission is to advance nursing, health studies, and healthcare by providing comprehensive training and preparation for individuals engaged in clinical research.
Goals
To prepare nurse clinical research professionals to:
- Enhance knowledge of standards and Good Clinical Practice Guidelines.
- Identify the aspects of human subject protection, care and safety
- Examine the operations of a clinical study which include design and documentation, audit, compliance, regulations, and monitoring.
- Understand the roles and responsibilities of monitoring organizations in the product development life cycle and the protocols.
- Understand the financial, legal, personnel, and strategic components necessary to run a clinical study.
- Apply leadership, ethics, and cultural competency as well as teamwork and communication strategies to the clinical study design and conduct.
- Identify how data are acquired and managed for a clinical study including collection, analysis, and quality control.
Student Learning Outcomes
- Students will demonstrate understanding of standards and Good Clinical Practice Guidelines in clinical research.
- Students will apply principles of human subject protection, care, and safety throughout the clinical study process.
- Students will evaluate clinical study operations including design, documentation, compliance, and monitoring responsibilities.
- Students will integrate leadership, ethics, cultural competency, and effective communication into clinical research practice.
