Executive Director, Human Research Protection Program

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Oversees the integrity and compliance of all human subjects research. Ensures all human research activities are conducted in accordance with strict ethical principles and in compliance with federal, state and institutional regulations and policies under a robust research compliance program.

• Plans, directs, supervises, and coordinates work activities of subordinates and staff, including hiring, coaching, evaluating, and terminating.
• Supervises NSU’s Institutional Review Board (IRB).
• Oversees the development and oversight of HRPP for NSU’s IRB.
• Assists with developing specific departmental goals, standards and objectives which directly support the strategic plan and vision of the organization, NSU Health, and the Division of Research.
• Provides expert direction, guidance, dissemination, support, and training for human-research-related federal regulations and guidelines, state regulations and guidelines, conflicts of interest, and research integrity.
• Develops processes and performance metrics to lead research compliance including, but not limited to, research monitoring, audits and research integrity.
• Implements and ensures all regulatory and compliance functions and systems are kept current to support the research compliance program and participates in continuous process improvement initiatives.
• Performs compliance reviews and internal audit checks based on risk assessment. Reviews to ensure protocol compliance with FDA regulations, study-specific and departmental standard operating procedures (SOPs), International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines.
• Leads external audits with FDA, Office of Research Protections (ORP), Sponsors and others. Prepare NSU for these audits and oversee creation and implementation of Corrective Action Plans.
• Communicates with and educate physicians, faculty, research staff, students, and new research hires regarding all aspects of research compliance and best practices.
• Completes special projects as assigned.
• Performs other duties as assigned or required.

Knowledge of Human Subjects Research Compliance and Institutional Review Board Regulations.

• Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
• Applies sound judgment and analytical reasoning to evaluate complex information, identify issues, and develop effective, evidence-based solutions.
• Demonstrates effective communication skills to lead and oversee teams, manage audits, and educate research personnel at all levels.
• Demonstrates strong complex problem-solving skills by analyzing multifaceted issues, identifying root causes, and developing innovative, practical solutions to ensure effective research operations and regulatory compliance.
• Exhibits decisive judgment and the ability to make sound decisions independently with minimal supervision.
• Possesses superior writing skills with the ability to craft clear, accurate, and persuasive documents, reports, and correspondence that effectively convey complex information to diverse audiences.
• Adaptable in dynamic environments, able to pivot quickly and take appropriate, effective action.

Masters Degree

In related field

A minimum of ten (10) years progressive work experience in three or more of the following areas: sponsored projects, research related financial compliance, research administration, research data management, research conflicts of interest, and other research compliance areas.

Certified Research Professional.

Yes

No

Nova Southwestern University is in full compliance with the Americans with Disabilities Act (ADA) and does not discriminate with regard to applicants or employees with disabilities and will make reasonable accommodation when necessary. NSU considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status or any other legally protected status.