Clinical Research Regulatory Operations Lead

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

Benefits offered by this job

Vacation & holidays

Health insurance

Metro U-Pass

403(b) Retirement Plan

Caregiver leave

Tuition remission

Job summary

Washington University in St. Louis is seeking a Regulatory Operations Leader for clinical studies in the Radiology Clinical Research Core (RadCore). You will oversee IRB, RDRC, and FDA submissions and provide a resource to clinical research staff for regulatory matters.

The role includes budgeting, billing compliance, and strategic planning of study protocols. Responsibilities include directing the research team, hiring and evaluating staff, and ensuring adherence to regulatory standards.

Qualifications

• Bachelor’s degree or equivalent combination of education/experience.
• Experience in regulatory operations for clinical studies preferred.
• Strong leadership and oversight capabilities in research programs.

Responsibilities

• Provides leadership and oversight to research programs.
• Oversees IRB, RDRC, and FDA submissions.
• Manages day-to-day functions of the research team and budgets.
• Ensures regulatory compliance and prepares budgetary reports.
• Onboards and trains new staff; conducts performance reviews.
• Develops policies and supervises the research team across all study phases.

Skills

Not Applicable

Education

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Job description

Washington University in St. Louis is seeking a Regulatory Operations Leader for clinical studies in the Radiology Clinical Research Core (RadCore). You will oversee IRB, RDRC, and FDA submissions and provide a resource to clinical research staff for regulatory matters.

The role includes budgeting, billing compliance, and strategic planning of study protocols. Responsibilities include directing the research team, hiring and evaluating staff, and ensuring adherence to regulatory standards.