Regulatory and Clinical Research Management | Arizona State University Campus Immersion

Skills & Competencies

Skills developed through this program

Auto-populatedfrom O*NET via SOC 11-9121.01

Skills

Reading ComprehensionActive ListeningWritingCoordinationSpeakingCritical ThinkingSocial PerceptivenessComplex Problem Solving

Knowledge

Customer and Personal ServiceEnglish LanguageAdministrativeMedicine and Dentistry

Abilities

Oral ComprehensionWritten ComprehensionOral ExpressionWritten ExpressionProblem SensitivityDeductive ReasoningInductive ReasoningInformation OrderingSpeech RecognitionSpeech Clarity

Tasks

Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performi
Assess eligibility of potential subjects through methods such as screening interviews, reviews of me

Technology

Data base user interface and query softwareAccounting softwareCategorization or classification softwareAnalytical or scientific softwareVideo conferencing software

Tools

Digital video equipmentLaptop computersLaser facsimile machinesPersonal computersPhotocopiersSmartphones

Work Values

IndependenceAchievementWorking ConditionsRecognitionRelationshipsSupport

Career Pathways

Occupations this program prepares you for

Auto-populatedfrom O*NET + BLS

Occupations matched to this program, with median wage, top wage, growth, and openings
SOC	Occupation	Method	Wage	Growth	Openings
Match confidence: medium11-9121.01	Clinical Research Coordinators	title_inference	—	—	—

Program Pathways

Credentials this program stacks toward

No program pathways.

What You'll Learn

Key competencies developed through this program

Auto-populatedfrom NSX Competency Framework

Mastery: advanced (Level 4)(based on Doctoral Degree)

Organizational research strategy — set priorities and resource allocation across a portfolio of clinical trials, aligning site capabilities with sponsor and regulatory expectations at an enterprise level.
Regulatory and compliance infrastructure — establish site-wide standard operating procedures and quality management systems to ensure sustained adherence to FDA, ICH, and IRB standards.
Principal investigator and sponsor relationships — cultivate and manage at a strategic level, representing the organization's clinical research capabilities in contract and protocol negotiations.
Workforce development programs — design and implement competency-based career pathways and mentorship structures for clinical research coordinators and junior staff across the organization.
Multi-site trial oversight — lead coordination across geographically distributed research sites by deploying project management software and governance frameworks to ensure protocol fidelity.
Adverse event reporting and safety governance — chair or advise data safety monitoring boards and safety review committees, providing expert judgment on risk–benefit assessments at the study-portfolio level.
Budget and resource management — direct financial planning for clinical research operations, overseeing accounting software-driven cost tracking, sponsor invoicing, and budget variance resolution.
Institutional research policy development — author and champion policies governing human subjects protection, data integrity, and research ethics across the institution in collaboration with IRB and legal counsel.
Knowledge translation and scientific dissemination — lead preparation of manuscripts, conference presentations, and regulatory submissions that communicate trial outcomes to scientific and policy audiences.
Organizational learning and continuous improvement — model and institutionalize evidence-based best practices in research coordination by applying active learning principles and performance metrics to drive systemic quality improvement.

Program Details

Detailed information about this program

No detailed information available.

Requirements

What you need to earn this credential

No requirements listed.

Financial Aid

Eligible funding programs

No funding information available.

Scholarships

No scholarships listed.