Regulatory Lead – Clinical Trials & Compliance

Socket.dev; Providence (RI); On-site; USD 58,000 - 96,000; Full time

Job summary

Brown University Health is seeking a Regulatory Coordinator to oversee clinical research regulatory requirements, from IND/IDE submissions to study closure. You will advise staff, collaborate with investigators, and ensure regulatory compliance across trials.

Ideal candidates have 3–5 years of regulatory experience, a health-related or scientific bachelor’s degree, and strong knowledge of FDA guidelines. The role supports the mission to Delivering health with care in Providence, RI.

Qualifications

• Bachelor’s degree in health-related or scientific field is required.
• Strong knowledge of all federal, local and state guidelines pertaining to Clinical Research.
• Must be able to work independently and make sound regulatory decisions.
• Excellent oral and written communication skills are essential.
• Experience with FDA guidelines and regulatory submissions is preferred.

Responsibilities

• Consults with and provides advice regarding regulatory documents and processes for clinical trials.
• Serves as regulatory SME through all phases of a study.
• Lead and mentor staff on regulatory initiatives and training.
• Develops and revises regulatory policies and procedures, and leads compliance projects.
• Ensure regulatory compliance with sponsors and investigators.

Skills

Self-starter

Interpersonal skills

Oral and written communication

Problem-solving

Detail-oriented

Organizational skills

Independent work

Team-oriented

Education

Bachelor’s degree in health-related or scientific field

Tools

Microsoft Office

Job description

Brown University Health is seeking a Regulatory Coordinator to oversee clinical research regulatory requirements, from IND/IDE submissions to study closure. You will advise staff, collaborate with investigators, and ensure regulatory compliance across trials.

Ideal candidates have 3–5 years of regulatory experience, a health-related or scientific bachelor’s degree, and strong knowledge of FDA guidelines. The role supports the mission to Delivering health with care in Providence, RI.