Regulatory Data Advisor
Brown University

To view the full job posting and apply for this position, go to: https://brown.wd5.myworkdayjobs.com/en-US/staff-careers-brown/job/South-Street-Landing/Regulatory-Data-Advisor_REQ199606

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 Opportunity

The Regulatory Data Advisor is a highly skilled and technically proficient improvement specialist responsible for supporting the services provided by Regulatory Advising and maintaining the Regulatory Advising Unit (RAU) Quality Assurance (QA) processes. This individual will be responsible for developing, implementing, and managing a robust internal reporting and tracking system, with a strong focus on creating and maintaining improvement processes. The incumbent must possess both technical expertise in data analysis, reporting tools, and systems design, as well as knowledge of regulatory compliance requirements. This position is a specialized role on a team of regulatory advisors and cross-trains with teammates to ensure seamless coverage.

This position will play a critical role in educating and supporting the research community on managing study related regulatory requirements, such as setting up regulatory binders, as needed, managing the ClinicalTrials.gov registration process, and compliance with annual review requirements and reports.

Job Qualifications

Education and Experience - Required

• Bachelor's degree or equivalent and 5+ years of relevant experience, including experience in project management, quality assurance, data analytics, clinical research, programming/AI systems, and/or regulatory compliance
• Extensive experience in developing and managing technical reporting systems, with proficiency in tools such as Excel, SQL, or similar platforms.
• Experience working in clinical research sites leading quality assurance projects
• Familiarity with research agreements, sponsor monitoring, EDC and CTMS.
• Experience with regulatory audits, inspections, and ensuring that reports and systems meet regulatory standards.
• Experience working with researchers conducting human subjects research.

Education and Experience - 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.
• Exceptional analytical and problem-solving skills with the ability to interpret complex data and present findings clearly.
• Training in automatization tools, AI and cloud services (AWS).
• Training in AI applications relevant to human subject research
• Strong ability to manipulate and analyze large datasets, ensuring that the QA and reporting systems deliver accurate, actionable insights.
• 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 Information

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

We are unable to offer Visa Sponsorship for this position.

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.

Recruiting Start Date:

2025-01-30

Job Posting Title:
Regulatory Data Advisor

Department:
Office of Research Integrity

Grade:
Grade 10

Worker Type:
Employee

Worker Sub-Type:

Regular

Time Type:
Full time

Scheduled Weekly Hours:
37.5

Position Work Location:
Remote Eligible

Statement on Equity, Diversity and Inclusion:

All positions require demonstrated ability to work collaboratively with faculty, staff, students, and other Brown and community stakeholders with diverse perspectives and demonstrated ability to contribute to an inclusive environment.

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.

Still Have Questions?

If you have any questions you may contact employment@brown.edu.

EEO Statement:

Brown University is an E-Verify Employer.

As an EEO/AA employer, 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, and caste, which is protected by our University policies.









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