Regulatory Advisor

Job Description:

About Brown

Brown University is a leading research university distinct for its student-centered learning and deep sense of purpose. Our students, faculty and staff are driven by the idea that their work will have an impact in the world.

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.  To learn about Brown University’s benefits, visit the University Human Resources web page here for further information.

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.

Qualifications

Education and Experience

• 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.

Preferred:

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

• SOCRA CCRP certification

Job Competencies

• 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.

Additional Requirements

• Applicants are asked to include a resume and cover letter with their application. 

• All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University.

Benefits of Working at Brown:

Information on the Benefits of Working at Brown can be found here.

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Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

This position is not eligible for visa sponsorship.

Still Have Questions?

If you have any questions you may contact [email protected].

Brown is an E-Verify Employer.

EEO Statement:

Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’s race, color, religion, sex, age, national or ethnic origin, disability, veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected under applicable law, in the administration of its policies, programs, and activities. The University recognizes and rewards individuals on the basis of qualifications and performance. The University maintains certain affirmative action programs in compliance with applicable law.