Reporting to the University Research Compliance Officer (RCO) for Tulane University, the Assistant Director, University Research Compliance (Assistant Director) designs, directs, monitors, and improves the Research Compliance Program, a university-wide compliance effort to prevent violations of law and applicable university policies and procedures. This is a high-profile, high-volume office that requires a self-directed individual who is organized, detail-oriented, and possesses a high level of interpersonal skills. An individual must have the ability to work independently and in a team environment.

The Assistant Director:

• Has the duties, responsibilities, and essential functions of the RCO as Assistant Director to the RCO.
• Develops, amends, implements, and oversees institutional policies, procedures, and guidance, to enable the conduct of research in compliance with multifaceted requirements of laws, regulations, accrediting body standards, and best practices in research activities while mitigating risks of fines and penalties imposed on the university. Subject matters overseen include investigations regarding allegations of research misconduct, research integrity compliance issues, research involving human subjects and vertebrate animals, grants and contracts, controlled substances licensing, operations of the Institutional Biosafety Committee, export controls, and record retention requirements.
• In coordination with appropriate University administrators (for example, Office of the General Counsel (OGC), Provost, and University Deans), investigates confidential research integrity and other research compliance matters in accordance with federal regulations and university policy. Manages communications with and reporting to federal regulators regarding research compliance matters. Oversees and directs compliance enforcement and appropriate corrective actions.
• Maintains a thorough knowledge of management principles and skills to effectively direct and manage the compliance program, including supervising/managing staff tasked with the program’s work. Has direct supervisory responsibilities over one professional-level employee, the Research Compliance Analyst.
• Responds to Freedom of Information Act (FOIA) and Louisiana Public Records Act requests related to research on behalf of the university in accordance with timelines imposed by law.
• Plans, organizes, and directs the university’s Responsible Conduct of Research (RCR) educational and training program designed to satisfy training requirements and directives imposed by the National Institutes of Health, National Science Foundation, and other funding agencies and regulators. This training is provided to the university community through a registered course and also to specific laboratories and individuals geared toward and tailored for their needs.
• Chairs the Research Compliance Operations Committee, reporting to the University Audit Committee.
• Coordinates internal compliance review and monitoring activities, including periodic review of policies and programs as required by federal and state laws.
• Serves as a liaison with the Office of General Counsel (OGC) to communicate legal issues and changes in the law or regulation.
• Consults with faculty, staff, and students on research compliance matters, including serving as the university’s point of contact for intake of allegations of research misconduct.
• Serves as the university’s liaison to professional organizations that study, update, and communicate developing national best practices regarding research compliance.
• Serves as a resource for faculty, staff, and students conducting research.
• Operates independently with a high level of interaction with senior administrators and research faculty.
• Fosters a university culture of compliance that promotes integrity and ethical behavior in all matters relating to research compliance and serves as a resource to researchers by increasing awareness of compliance regulation, best practices, and institutional policies.
• Performs specific research compliance-related duties delegated by the RCO.

Minimum Education

• Advanced degree with three years of regulatory compliance experience or bachelor’s degree with five years of regulatory compliance experience.

Preferred Qualifications

• Juris Doctor or another advanced degree.
• In-depth knowledge of 42 CFR Part 93 Public Health Service Policies on Research Misconduct.
• Knowledge of the Health Insurance Portability and Accountability Act (HIPAA).
• Familiarity with conducting or administering research involving humans, vertebrate animals, infectious agents, and recombinant DNA.
• Experience with writing policies and standard operating procedures.