Assistant Director Compliance And Regulatory Services jobs in United States
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Inside Higher Ed · 1 month ago

Assistant Director Compliance And Regulatory Services

Brown University is a leading research university known for its student-centered learning. The Assistant Director of Compliance and Regulatory Services provides leadership for HRPP functions, overseeing regulatory advising and compliance initiatives related to human subjects research.

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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

Qualification

Human research protectionsRegulatory advisingQualityComplianceCertified IRB ProfessionalResearch administrationTeam buildingLeadership skillsCommunication skillsProblem solvingStrategic decision making

Required

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
Supervisory experience or demonstrated aptitude and capacity to supervise
Experience working in an academic or clinical research setting
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

Preferred

Experience in educational setting and/or delivering education and training
advanced degree (e.g., Master's, JD, PhD)
Certified IRB Professional (CIP) certification at time of hire preferred
Experience with electronic submission systems preferred

Benefits

Flexible work/life balance
Summer hours
Winter break
Comprehensive Benefits package including time off
Annual paid holidays
Benefits offerings including health, dental, vision, tuition assistance, retirement, wellness, employee discounts and more

Company

Inside Higher Ed

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Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.

Funding

Current Stage
Growth Stage
Total Funding
unknown
2022-01-10Acquired
2006-08-31Series Unknown

Leadership Team

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Stephanie Shweiki
Director, Foundation Partnerships
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