Clinical Trials Regulatory Lead

Rhode Island Hospital; United States; Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements for the department and support regulatory/compliance across trials. The role involves managing trial submissions from approval to closure, advising investigators, and maintaining regulatory integrity with sponsors and IRBs.

The candidate will serve as SME across study phases, coordinate IND/IDE submissions, and lead process improvements.

Formación

• Bachelor's degree in health-related or scientific field is required.
• Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research.
• Independent judgment and ability to work with minimal supervision.
• Strong communication and teamwork abilities.
• Familiarity with FDA guidelines and regulatory databases.

Responsabilidades

• Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct.
• Serves as the regulatory subject matter expert through all phases of clinical study.
• Leads and mentors other staff on regulatory initiatives and training.
• Develops and revises regulatory policies and procedures; initiates special projects.
• Ensures regulatory compliance with sponsor requirements; liaises with sponsors and investigators.
• Coordinates IND and IDE submissions and prepares regulatory materials.
• Interprets protocols and creates consent documents for studies.
• Manages regulatory approvals and maintains study binder.

Conocimientos

Regulatory compliance

FDA guidelines

IND/IDE submissions

Clinical research knowledge

Interpersonal skills

Educación

Bachelor's degree in health-related or scientific field

Herramientas

Microsoft Office

Descripción del empleo

Brown University Health seeks a Regulatory Coordinator to oversee clinical research regulatory requirements for the department and support regulatory/compliance across trials. The role involves managing trial submissions from approval to closure, advising investigators, and maintaining regulatory integrity with sponsors and IRBs.

The candidate will serve as SME across study phases, coordinate IND/IDE submissions, and lead process improvements.