Clinical Research Regulatory Lead

Washington University in St. Louis; United States; On-site; USD 71,000 - 110,000; Full time

Job summary

Washington University in St. Louis is seeking an experienced regulatory operations leader to oversee clinical studies in the Radiology Clinical Research Core (RadCore). You will lead planning, conduct, and evaluation of clinical research and supervise IRB, RDRC, and FDA submissions.

You will guide staff, ensure regulatory compliance, and manage budgets and billing for studies while promoting high-quality research practices across the team.

Qualifications

• Bachelor's degree or combination of education and/or experience may substitute for minimum education.
• BLS certification from AHA or Red Cross may be required.
• Clinical or research experience: 4 years.
• Supervisory experience: 1 year.

Responsibilities

• Provides leadership and oversight to our research programs.
• Will oversee all IRB, RDRC, and FDA submissions.
• Serves as a resource to provide comprehensive information to clinical research staff.
• May perform duties inclusive of those delegated to a Clinical Research Coordinator III and/or Clinical Research Supervisor.
• Assists in the management of the day-to-day functions of the research team.
• Utilizes critical thinking in the management of clinical trials.
• Develops and implements policies and procedures.
• Provides comprehensive direction to clinical research personnel.
• Supervises research team, including hiring, terminating, and scheduling assignments to personnel; provides performance feedback/annual reviews.
• Onboards, educates, and trains new staff; serves as a point of reference for current research staff.
• Identifies problems and/or inconsistencies with personnel and study conduct and develops and implements corrective action plans.
• Provides higher level oversight and management of all phases of study/protocol lifecycle.
• May assist in the strategic planning of clinical research, including evaluation of the research team\'s bandwidth for new trials and assessment of new protocols and subsequent assignment of the protocol to research staff.
• May order supplies needed for the research projects and research group.
• May assist in monitoring ongoing financial state, patient recruitment milestones, and personnel resources necessary to conduct the research. May assist financial and grant administrators with federal and sponsor funded trials.
• Researches and recommends new methods and procedures to maintain standards and improve quality.
• Performs other duties incidental to the work described above.

Skills

Analytical Thinking

Clinical Research

Interpersonal Communication

Leadership

Oral Communications

Prioritization

Problem Solving

Written Communication

Education

Bachelor's degree

Job description

Washington University in St. Louis is seeking an experienced regulatory operations leader to oversee clinical studies in the Radiology Clinical Research Core (RadCore). You will lead planning, conduct, and evaluation of clinical research and supervise IRB, RDRC, and FDA submissions.

You will guide staff, ensure regulatory compliance, and manage budgets and billing for studies while promoting high-quality research practices across the team.