Clinical Research Regulatory Operations Lead

Washington University; St. Louis (MO); On-site; USD 71,000 - 110,000; Full time

Benefits offered by this job

Vacation benefits

Comprehensive health insurance

Metro transit U-Pass

403(b) Retirement Savings Plan

Job summary

Washington University in St. Louis is seeking a Regulatory Operations Leader to manage clinical studies within the Radiology Clinical Research Core (RadCore). The role oversees IRB, RDRC, and FDA submissions, budgets, and compliance while guiding a research team and ensuring high quality standards across all study phases.

The position emphasizes leadership, strategic planning, and the ability to supervise recruitment, budgeting, and policy implementation in a demanding academic environment.

Qualifications

• Bachelor's degree or combination of education and/or experience may substitute for minimum education.
• Basic Life Support certifications (BLS) required.
• Clinical Or Research experience: 4 years; Supervisory experience: 1 year.

Responsibilities

• Provides leadership and oversight to research programs.
• Oversees all IRB, RDRC, and FDA submissions.
• Serves as a resource with comprehensive information for clinical research staff.
• May perform duties of Clinical Research Coordinator III or Supervisor.
• Manages day-to-day functions of the research team.
• Uses critical thinking in management of clinical trials.
• Develops and implements policies and procedures.
• Provides direction to clinical research personnel.
• Supervises staff including hiring, termination, and performance reviews.
• Onboards, educates, and trains new staff; serves as a reference for current staff.

Skills

Analytical Thinking

Clinical Research

Interpersonal Communication

Leadership

Oral Communications

Prioritization

Problem Solving

Written Communication

Education

Bachelor's degree or equivalent

Job description

Washington University in St. Louis is seeking a Regulatory Operations Leader to manage clinical studies within the Radiology Clinical Research Core (RadCore). The role oversees IRB, RDRC, and FDA submissions, budgets, and compliance while guiding a research team and ensuring high quality standards across all study phases.

The position emphasizes leadership, strategic planning, and the ability to supervise recruitment, budgeting, and policy implementation in a demanding academic environment.