MACPR Specializations

Clinical Research Management

The Clinical Research Management Specialization focuses on the management of systems and processes in the conduct of clinical trials to prepare graduates to lead complex national and international clinical research operations. Graduates of this track will have attained the skills to work as Clinical Research Coordinators (CRCs) or Clinical Research Associates (CRAs) representing the study sponsor or investigation site and to advance their careers as clinical research administrators.

In addition to the core coursework, students in the Clinical Research Management Specialization will complete the following courses:

Required specialization courses:

Nursing 7404 Clinical Research Project Management and Leadership
Nursing 7481 Data Management and Informatics in Clinical Research
Nursing 7482 Principles of Quality Management for Medical Product Development
Nursing 7599 Capstones in Applied Clinical and Preclinical Research

Select two of the following:

HTHRSC 5500 Introduction to Pathophysiology
Nursing 7402 Economic Evaluation of Healthcare Interventions
Pharmacology 5700 Introduction to Personalized Therapeutics and Pharmacogenomics
Pharmacy 7570 Pharmaceutical Safety & Risk Management

Program Overview and Curriculum
Sample Course Plans
Course Descriptions

 

Regulatory Affairs

The Regulatory Affairs Specialization emphasizes the assurance of the safe and effective medical product development and use throughout the product life cycle through regulatory oversight and strategy. Graduates from this track will have the skills to interpret FDA and international agencies’ regulations and guide regulatory strategy and operations. Regulatory compliance professionals work in many settings, including government, industry, clinical research organizations and academic institutions.

In addition to the core coursework, students in the Regulatory Affairs Specialization will complete the following courses:

Required specialization courses:

Nursing/Pharmacy 7460 Regulatory Strategy, Writing and Leadership
Pharmacy 7570 Pharmaceutical Safety & Risk Management
Nursing 7482 Principles of Quality Management for Medical Product Development
Pharmacy 7572 Federal Regulations of Medical Products
                      
Nursing/Pharmacy 7599
Capstone in Applied Clinical and Preclinical Research

Select one of the following:

Nursing 7481 Data Management and Informatics in Clinical Research
Pharmacy 7580 Principles of Safety Pharmacology

Program Overview and Curriculum
Sample Course Plans
Course Descriptions