Regulatory Coordinator - Clinical Trials Lead

Lifespan; 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 for the department and manage trial regulatory activities from approval to closure.

You will advise on regulatory documents, coordinate IND/IDE submissions, and act as a regulatory SME across all study phases, while mentoring staff and collaborating with investigators to resolve inquiries.

Qualifications

• Bachelor's degree in health-related or scientific field is required.
• Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research.
• Must be independent, capable of sound judgment on regulatory issues and able to work independently.
• SoCRA certification or eligibility within 18 months of hire.

Responsibilities

• Consults with and advises on regulatory documents and processes for clinical trials.
• Serves as regulatory subject matter expert through all phases of clinical study.
• Leads and mentors clinical research staff and drives process improvements.
• Develops and revises regulatory policies and procedures; leads projects and training.
• Ensures regulatory compliance per sponsor requirements and timelines.
• Interacts with sponsors, investigators and team members with written, oral and meeting updates.
• Coordinates IND/IDE submissions and regulatory approvals.

Skills

Regulatory knowledge

Independent judgement

Strong communication

Problem solving

Organization

Teamwork

Education

Bachelor's degree in health-related or scientific field

Tools

Microsoft Office

Job description

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements for the department and manage trial regulatory activities from approval to closure.

You will advise on regulatory documents, coordinate IND/IDE submissions, and act as a regulatory SME across all study phases, while mentoring staff and collaborating with investigators to resolve inquiries.