Assistant Director Compliance and Regulatory Services

Brown University • Searchlight, NV

39d • Hybrid

About The Position

Reporting to the HRPP Director, the Assistant Director, Compliance and Regulatory Services (“Assistant Director”) provides strategic and operational leadership for two complementary HRPP functions: regulatory advising services and quality and compliance initiatives related to human subjects research. Working closely with researchers at Brown University, Brown University Health, and Care New England, the Assistant Director oversees professional staff, including regulatory advisors and the Quality & Compliance team members, ensuring that investigators receive guidance on IRB submissions, post-approval regulatory requirements, clinical trial compliance, FDA regulations, and clinical study documentation. The role also coordinates monitoring activities, including self-directed and for-cause audits, in collaboration with the Quality and Compliance Manager. The Assistant Director evaluates program effectiveness by analyzing metrics, outcomes, and tracking progress to inform continuous improvement initiatives. As a member of the HRPP leadership team, the Assistant Director collaborates with the HRPP Director and fellow Assistant Directors on strategic planning, policy development, and program evaluation. The position promotes operational excellence through data-informed decision-making, staff development, and process improvement. In addition, the Assistant Director represents the HRPP on institutional committees, working groups, and external professional forums, and contributes to the development and delivery of educational resources and training for human subjects researchers and IRB members.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience, plus 7+ years related experience in research administration, at least 5 of which must be in human research protections administration
• In-depth understanding of all applicable federal and State regulations pertaining to human subjects research.
• Ability to advise and counsel on matters of general research compliance and ethical human participant research practices.
• Proven track record of strong leadership and team building skills and experience working collaboratively to motivate others.
• Ability to supervise effectively.
• High level of experience and comfort working independently with faculty, staff, students, medical professionals and external agencies in complex organizations.
• Must be able to translate scientific disciplinary research into plan for implementing a project with research participants
• Must understand the service nature of this unit and this position
• Ability to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities.
• Must possess excellent written and verbal skills.
• Strong problem solver and strategic decision maker.

Nice To Haves

• Experience in educational setting and/or delivering education and training
• Advanced degree (e.g., Master’s, JD, PhD)
• Supervisory experience or demonstrated aptitude and capacity to supervise
• Experience working in an academic or clinical research setting
• Certified IRB Professional (CIP) certification at time of hire preferred
• Experience with electronic submission systems preferred

Responsibilities

• Provides strategic and operational leadership for regulatory advising services and quality and compliance initiatives related to human subjects research.
• Oversees professional staff, including regulatory advisors and the Quality & Compliance team members.
• Ensures that investigators receive guidance on IRB submissions, post-approval regulatory requirements, clinical trial compliance, FDA regulations, and clinical study documentation.
• Coordinates monitoring activities, including self-directed and for-cause audits, in collaboration with the Quality and Compliance Manager.
• Evaluates program effectiveness by analyzing metrics, outcomes, and tracking progress to inform continuous improvement initiatives.
• Collaborates with the HRPP Director and fellow Assistant Directors on strategic planning, policy development, and program evaluation.
• Promotes operational excellence through data-informed decision-making, staff development, and process improvement.
• Represents the HRPP on institutional committees, working groups, and external professional forums.
• Contributes to the development and delivery of educational resources and training for human subjects researchers and IRB members.

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: Director
• Number of Employees: 5,001-10,000 employees