Clinical Research Management Curriculum Overview

Developed with input from industry leaders, our MS and certificate curriculum equips graduates to address the field’s most pressing issues and thrive in collaborative environments.

MS Curriculum Overview

The Clinical Research Management MS curriculum consists of 13 courses totaling 35 credit hours, and can be completed in as few as 5 academic terms (20 months). A decelerated plan of study is also available that allows students to move at a slower pace, with fewer courses per term. Much of the coursework is self-paced and asynchronous, but with some synchronous elements sprinkled in to assure the formation of peer relationships with members of your cohort.

An important component of the curriculum is the capstone project, which begins in your 2nd academic term, and culminates in the 5th, and final, academic term. The goal of the capstone project exercise is for you to identify a critical health care challenge and draw upon knowledge and skills gained through your coursework to develop a transformative solution.

And because we recognize that some students have a unique focus, the program allows for specialization by allowing you to select between two tracks: Strategic Leadership/Communications or Operations.

MS Coursework Details

The coursework is broken down as follows:

11 credit hours in foundational courses
14 credit hours in core courses
4 credit hours in concentration courses
6 credit hours of capstone project

Below, you will find the specific course listings in each category of coursework.

MS Program Course Requirements

Foundational Courses (11 credit hours)

CRM 701	Research Design and Methods in Clinical Research	3 Credits
CRM 702	Data Analysis and Interpretation in Clinical Research	3 Credits
CRM 703	Leadership and Professionalism I	1 Credit
CRM 704	Leadership and Professionalism II	1 Credit
CRM 721	Clinical Operations and Project Management	3 Credits

Core Courses (14 credit hours)

CRM 711	Ethical and Participant Safety Considerations	3 Credits
CRM 712	Medicines Development, Regulation, Industry	3 Credits
CRM 722	Clinical Studies Development	2 Credits
CRM 731	Quality Systems and Risk Management	3 Credits
CRM 732	Data Management and Informatics	3 Credits

Strategic Leadership/Communications Courses (4 credit hours)

Students select 2 out of the 3 courses offered.

CRM 751	Conflict Resolution and Negotiations	2 Credits
CRM 752	Design Thinking	2 Credits
CRM 753	Business Communication Skills for Healthcare Professionals	2 Credits

Operations Courses (4 credit hours)

Students select 2 out of the 3 courses offered.

CRM 761	Project Management	2 Credits
CRM 762	Financial Management for Clinical Research Professionals	2 Credits
CRM 763	Technical Writing for the Regulatory Professional	2 Credits

Capstone Experiences (6 credit hours)

CRM 715	Capstone Project 1	1 Credit
CRM 716	Capstone Project 2	1 Credit
CRM 717	Capstone Project 3	1 Credit
CRM 718	Capstone Project 4	3 Credits

Selecting a Concentration

During program orientation, our program director will discuss the options and help you select a concentration that will help you pursue your desired career outcome. A snapshot of the two concentrations in our Clinical Research Management MS program are shown below.

Strategic Leadership/Communications

Being able to communicate a vision and motivate your team is critical for achieving organizational success. This is especially true in the clinical research industry, where effective management can be the key to navigating an innovative treatment through the complex approval process. The Strategic Leadership/Communications concentration is an excellent alternative for those who aspire to become leaders in the field.

Having a solid foundational knowledge of the clinical trial process is paramount, but sometimes it’s the soft skills that can make all the difference. This concentration focuses on the intangibles that define effective leaders — the little things you do that may go unnoticed but can yield the biggest results.

The Strategic Leadership/Communications concentration can help you:

Increase your understanding of successful managerial concepts and how you can apply them in your organization
Learn effective negotiation, team building, and conflict resolution strategies
Communicate more effectively by enhancing your business writing and presentation skills

Operations

Successfully managing a clinical trial requires more than a strong background in biomedical sciences. It takes an understanding of how to navigate a complex project, the financial acumen to oversee budgets and spending, and the communication skills to clearly and professionally articulate your findings. The Operations concentration is ideal for those who are new to the field or transitioning to a clinical research management focused career from a related healthcare occupation.

The Operations concentration can supplement your healthcare-related curriculum with courses focused on relevant, practical skills to help you succeed as in the industry. You’ll explore areas such as project management, finance, and decision making, with specific emphasis on their unique applications within the clinical research management arena.

The Operations concentration can help you:

Develop the skills to oversee a project and lead it to a successful outcome
Enhance your ability to assess the factors that can influence the performance of a clinical trial
Gain competency in applying tools and techniques to assist in financial decision-making and budget management

Certificate Curriculum Overview

The Clinical Research Management Certificate curriculum consists of 6 courses totaling 12 credit hours and can be completed in 3 academic terms (12 months). There are two certificate plan options: the Project Management Certificate and the Regulatory Affairs Certificate.
Either certificate is an ideal choice for working professionals who need a shorter time commitment, want focused training in a specific area or are unsure about pursing a MS degree.

The primary difference between the Graduate Certificate and the MS program is that certificate students do not complete a capstone project. If you are deciding which option best fits your goals, we encourage you to contact the Program Director to discuss your interests and career path.

As a Certificate student, you will take the same courses as MS students, taught by the same faculty. You will simply follow a different plan of study, which also makes it easy to transition into the MS program if you choose to continue.

Below you will find the plan of study for each certificate pathway.

Project Management Certificate

Term 1 – 4 Credit Hours

CRM 701	Research Design and Methods in Clinical Research	3 Credits
CRM 703	Leadership and Professionalism	1 Credit

Term 2 – 4 Credit Hours (Choose Two Classes)

CRM 761	Project Management	2 Credits
CRM 762	Financial Management for Clinical Research Professionals	2 Credits
CRM 763	Technical Writing for the Regulatory Professional	2 Credits

Term 3 – 4 Credit Hours

CRM 704	Leadership and Professionalism II	1 Credits
CRM 721	Clinical Operations and Project Management	3 Credits

Regulatory Affairs Certificate Curriculum Plan