Clinical Trials Regulatory Assistant

Brown-University-Health-1; Providence (RI); On-site; USD 42,000 - 69,000; Full time

Job summary

Brown University Health is seeking a Regulatory Assistant to support regulatory tasks for clinical research within the department. The role ensures regulatory integrity from trial approval to closure and collaborates with regulatory staff to maintain compliance in all submissions.

Responsibilities include document preparation, collecting signatures, handling SUSARs, IRB/RDC filings, and coordinating sponsor visits, with a focus on accuracy and timely communication across teams.

Qualifications

• Bachelor’s degree in Applied or Life Sciences or related area, including courses in research methodologies.
• Knowledge of theory and techniques of research methodology.

Responsibilities

• Assist with the preparation and collection of study-related regulatory documents (e.g., CVs, Financial Disclosure Forms, FDA 1572).
• May collect signatures to ensure accuracy of study documents.
• Receives and processes clinical trial external safety reports, including SUSARs.
• May process and file IRB and RDC approvals; may update the Clinical Trial Management System.
• May complete minor revisions to clinical trials (e.g., personnel updates, continuing reviews).
• May assist with sponsor visits (Monitoring Visits, Site Initiation Visits, Close-Out Visits).
• Liaises with regulatory staff, sponsors, investigators, and study team members.
• Participates in Study Initiation Visits and Interim Monitoring Visits.
• Performs other duties as assigned.

Skills

Detail-oriented

Organizational skills

Self-starter

Interpersonal skills

Team-oriented

Oral and written communication

Microsoft Office

Database applications

Education

Bachelor’s degree in Applied or Life Sciences

Research methodologies coursework

Tools

Microsoft Office

Database applications

Job description

Brown University Health is seeking a Regulatory Assistant to support regulatory tasks for clinical research within the department. The role ensures regulatory integrity from trial approval to closure and collaborates with regulatory staff to maintain compliance in all submissions.

Responsibilities include document preparation, collecting signatures, handling SUSARs, IRB/RDC filings, and coordinating sponsor visits, with a focus on accuracy and timely communication across teams.