Clinical Trials Regulatory Assistant

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

Job summary

Brown University Health seeks a Regulatory Assistant to support regulatory activities in clinical research. You will help prepare regulatory documents, collect signatures, and assist with sponsor visits, while ensuring compliance from study approval through closure.

The role requires a Bachelor's in life sciences or related field or equivalent experience, strong organization, and communication skills, with a focus on regulatory accuracy in a fast-paced environment at Rhode Island Hospital.

Qualifications

• Bachelor’s degree in Applied or Life Sciences or related area; alternative: 2-3 years of relevant experience.

Responsibilities

• Assist with the preparation and collection of study related regulatory documents (CV, ML, Financial Disclosure Forms, Conflict of Interest Forms, FDA 1572, Delegation of Authority/Staff Signature Logs).
• May collect signatures to ensure accuracy of study documents.
• Process external safety reports including SUSARs; may update the Clinical Trial Management System.
• Assist with preparation and setup of sponsor visits (Monitoring, Site Initiation, Close-Out Visits).
• Liaise with regulatory staff, sponsors, investigators and study team members.
• Participate in Study Initiation Visits and Interim Monitoring Visits.
• Perform other duties as assigned.

Education

Bachelor's degree in Applied or Life Sciences

Experience substituted for degree

Tools

Microsoft Office

Database applications

Job description

Brown University Health seeks a Regulatory Assistant to support regulatory activities in clinical research. You will help prepare regulatory documents, collect signatures, and assist with sponsor visits, while ensuring compliance from study approval through closure.

The role requires a Bachelor's in life sciences or related field or equivalent experience, strong organization, and communication skills, with a focus on regulatory accuracy in a fast-paced environment at Rhode Island Hospital.