Clinical Trials Regulatory Lead

Brown-University-Health-1; Providence (RI); On-site; USD 58,000 - 96,000; Full time

Job summary

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements within the department, guiding trials from approval to closure and advising staff on compliance issues.

The role partners with investigators to resolve regulatory inquiries, coordinates IND/IDE submissions, and maintains study regulatory binders while mentoring junior staff to improve processes and ensure sponsor expectations are met.

Qualifications

• Bachelor’s degree in health-related or scientific field is required.
• Knowledge of federal, local and state guidelines for Clinical Research.
• Ability to work independently under regulatory requirements.
• Strong communication and problem-solving skills.
• SoCRA certified or eligible within 18 months.

Responsibilities

• Consults with and advises regulatory documents and processes for clinical trials.
• Serves as regulatory SME through all phases of a study.
• Leads and mentors other clinical research staff.
• Develops and revises regulatory policies and procedures.
• Coordinates IND/IDE submissions.
• Maintains study regulatory binder.
• Responds to stipulations and shepherds applications to approvals.
• Supports regulatory training and process improvement.

Skills

Regulatory knowledge

Independent judgment

Regulatory communication

Team mentorship

Attention to detail

Education

Bachelor’s degree in health-related or scientific field

Tools

Microsoft Office

Database applications

Job description

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements within the department, guiding trials from approval to closure and advising staff on compliance issues.

The role partners with investigators to resolve regulatory inquiries, coordinates IND/IDE submissions, and maintains study regulatory binders while mentoring junior staff to improve processes and ensure sponsor expectations are met.