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Regulatory and Clinical Research Management, DPP

Prepare to address the complex landscape of the global research industry. This flexible, fully online program gives you the opportunity for a world-class education, taught by innovative faculty and professionals, while you continue to advance in your career.

Program description

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

An interdisciplinary curriculum weaves innovation, technology, bioinformatics, policy, leadership methods and strategies with regulatory and clinical research management to ensure 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 lifecycle; 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 ASU 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 medical products, procedures and diagnostics to advance health care.

GI Bill® benefits

This new program is not yet approved for use with GI Bill® benefits.

GI Bill® is a registered trademark of the U.S. Department of Veterans Affairs. More information about education benefits offered by VA is available at the official U.S. government website at https://www.benefits.va.gov/gibill/.

At a glance: program details

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

Applicants must fulfill the requirements of both the Graduate College and the Edson College of Nursing and Health Innovation.

Applicants are eligible to apply to the program if they have earned a master's degree in regulatory science, clinical research management or a similar degree in a related field from a regionally accredited institution.

Applicants must have a minimum cumulative GPA of 3.00 (scale is 4.00 = "A") in an applicable master's degree program.

Applicants are required to submit:

  1. graduate admissions application and application fee
  2. official transcripts
  3. personal statement
  4. professional resume
  5. two letters of recommendation
  6. proof of English proficiency

Additional Admission Information
An applicant whose native language is not English must provide proof of English proficiency regardless of their current residency.

Interested students must have a master's degree.

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Career outlook

The pharmaceutical industry provides an array of career opportunities for professionals with doctorate degrees. Technological advances such as artificial intelligence 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. 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

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