Regulatory Advisor

Brown University

28d • Remote

About The Position

The Regulatory Advisor serves as a central resource for researchers at Brown University, Brown University Health, and Care New England proposing to conduct biomedical, social or behavioral research involving human subjects, with particular emphasis on FDA-regulated and sponsor-funded clinical research. Working closely with researchers as a part of the Human Research Protection Program (HRPP) Office, the Regulatory Advisor provides guidance on the preparation and submission of human subjects submissions and required documentation to the Institutional Review Board (IRB). This position will work independently with researchers providing advice regarding the design of studies and help translate research ideas into study protocol submissions to meet IRB regulatory and ethical requirements. This role contributes to the development of educational materials and guidance resources to support investigators, particularly those new to human subjects research, in understanding regulatory requirements and navigating the IRB submission process. This position plays a critical role in educating and advising the research community on study-related regulatory requirements, including regulatory documentation practices, ClinicalTrials.gov requirements, and ongoing IRB compliance obligations.

Requirements

• Bachelor’s degree and 5+ years of experience in academic or industry-based clinical, social, or behavioral research or research administration or equivalent combination of education and experience.
• Experience supporting or collaborating with researchers conducting human subjects research.
• Effective presentation, facilitation, and communication skills, both oral and written
• Must be able to communicate with tact and compassion.
• Must pay attention to detail and consistency within multiple documents.
• Must be able to translate scientific disciplinary research into study protocols involving research participants.
• Must understand the service nature of the position.
• Must be a team player.
• Must be able to prioritize competing demands and deadlines.
• Must have familiarity with federal regulations and ethical requirements for human subject participation in clinical, social, and behavioral research.

Nice To Haves

• Experience with NIH, GCP, OHRP, FDA, and federal regulations for human subject participation in clinical, social, and behavioral research.
• SOCRA CCRP certification

Responsibilities

• Provides guidance on the preparation and submission of human subjects submissions and required documentation to the Institutional Review Board (IRB).
• Provides advice regarding the design of studies and help translate research ideas into study protocol submissions to meet IRB regulatory and ethical requirements.
• Contributes to the development of educational materials and guidance resources to support investigators, particularly those new to human subjects research, in understanding regulatory requirements and navigating the IRB submission process.
• Educates and advises the research community on study-related regulatory requirements, including regulatory documentation practices, ClinicalTrials.gov requirements, and ongoing IRB compliance obligations.

Benefits

• Brown University offers a flexible work/life balance; summer hours, winter break and a comprehensive Benefits package including time off, annual paid holidays; benefits offerings including health, dental, vision, tuition assistance, retirement, wellness, employee discounts and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level