Program Overview

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Regulatory and Clinical Research Management, DPP

The Doctor of Professional Practice program in regulatory and clinical research management prepares global leaders to influence the medical and healthcare industry through the development of new medical products such as drugs, biologics, vaccines, and devices to address the health needs of consumers.

Program Description

An interdisciplinary curriculum weaves innovation, technology, bioinformatics, policy, leadership methods, and strategies with regulatory and clinical research management to ensure that students meet industry workforce needs and are capable, high-functioning, innovative leaders. Core courses provide a strong foundation in leadership and communication; the regulations and development of medical products through the life cycle; quality control; application of ethics to animal and human research; pharmacology, drugs, and society; biologics; and small molecules. Other topics include the principles and concepts of innovation, systems thinking in a complex environment, artificial intelligence, and business. These core courses are balanced with offerings from other colleges and departments, providing students with the knowledge base, skills, and abilities to tackle practical health concerns and ethical dilemmas; navigate the global regulatory landscape; and contribute to the discovery of medical products, procedures, and diagnostics to advance healthcare.

At a Glance

• College/school: Edson College of Nursing and Health Innovation
• Location: Online
• STEM-OPT extension eligible: No

Degree Requirements

60 credit hours, including the required applied project course (RCR 793)

Required Core (24 credit hours)

• RCR 710 Leadership Communication in the Regulatory and Clinical Research Industry (3)
• RCR 712 Leadership for Change in Regulatory and Clinical Research (3)
• RCR 713 Quality Control and Assurance Through the Medical Product Cycle (3)
• RCR 714 Ethical and Regulatory Aspects of Clinical Research (3)
• RCR 715 Drugs and Society: Milestones in Drug Development (3)
• RCR 716 Development and Manufacturing of Small Molecules (3)
• RCR 717 Development and Regulation of Biologics (3)
• RCR 718 Planning and Execution of Clinical Research (3)

Restricted Electives (18 credit hours)

• BMD 502 Foundations of Biomedical Informatics Methods I (3)
• BMD 667 Regulation of Medical Diagnostics (3)
• BMI 601 Fundamentals of Health Informatics (3)
• HCI 542 Systems Thinking in a Complex Environment (3)
• HCI 548 Advanced Principles and Concepts of Innovation (3)
• HCI 550 Health Care Policy and Innovation (3)
• NUR 617 Foundational Concepts in Science and Statistics (3)

Electives (6 credit hours)

• CIS 565 Artificial Intelligence in Business (3)
• NUR 608 Qualitative Research Design and Methods (3)
• NUR 609 Quantitative Research Design and Methods (3)
• NUR 618 Advanced Research-based Health Policy Through Leadership and Innovation Science (3)

Culminating Experience (12 credit hours)

• RCR 793 Applied Project (12)

Admission Requirements

• General university admission requirements: All students are required to meet general university admission requirements.
• Applicants must have earned a master's degree in regulatory science or clinical research management, or a similar degree in a related field from a regionally accredited institution.
• Minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.
• Required documents:
  • Graduate admission application and application fee
  • Official transcripts
  • Personal statement
  • Professional resume
  • Two letters of recommendation
  • Proof of English proficiency

Tuition Information

When it comes to paying for higher education, everyone’s situation is different. Students can learn about ASU tuition and financial aid options to find out which will work best for them.

Career Opportunities

The life sciences industries provide an array of career opportunities for professionals with doctorate degrees. Technological advances such as AI and machine learning may advance the development and approval of new products to market. Both regulatory and clinical research management personnel are an integral part of this process. Directors and managers in regulatory affairs manage the regulatory aspects of the product through all phases of development, approval, and post-approval. Professionals in clinical trial management positions are responsible for the planning, oversight, and execution of study and program-level deliverables, managing high-performing teams in a fast-paced environment.

• Career opportunities include:
  • Clinical data manager
  • Clinical operations director or manager
  • Compliance officer or manager
  • Director or manager of quality control
  • Director or manager of quality management
  • Director or manager of post-market quality
  • Program or project director manager

Additional Information

This program is designed to provide students with the knowledge, skills, and abilities to succeed in the field of regulatory and clinical research management. With its interdisciplinary approach and focus on innovation, technology, and leadership, graduates of this program will be well-prepared to navigate the complex landscape of the global research industry and contribute to the development of new medical products and procedures.