Director of Research Integrity and Compliance

Overview

The newly configured Office of Research, led by the Chief Research Officer, partners and collaborates with the different programs, assets, and resources across ECU campuses and facilities along with the UNC designated centers and institutes.

The Office of Research provides oversight of ECU’s research enterprise, including grant administration and ethical practices;

ensures compliance with the federal, state, and University rules and regulations; and includes the following units and committees or boards : Pre-Award Services, Post-Award Services, Research Integrity and Compliance, Compliance Monitoring, Research Administration Analytics, Research Development, Institutional Animal Care and Use Committee, and the University Medical and Behavioral Institutional Review Board.

Job Duties The Director of ORIC provides leadership / supervision in Conflicts of Interest, Conflicts of Commitment, Responsible Conduct of Research, Research Misconduct, Research Security, and Export Controls.

The Director is responsible for ensuring East Carolina University complies with all applicable federal, state, and university regulations related to these areas.

The position serves as a liaison with the Human Research Protection office, the IBC, Risk Management, Financial Services, and Procurement and works closely with ECU Health, a primary site for clinical education, trials, and research, to ensure compliance in the areas of Conflicts of Interest, Conflicts of Commitment, Responsible Conduct of Research, Research Misconduct, Research Security, and Export Controls.

Job Duties :

Leadership / Supervision 40%

• Supervises staff who support Conflicts of Interest, Conflict of Commitment, Responsible Conduct of Research, Research Misconduct, Research Security, and Export Controls
• Works closely with Internal Audit and Management Advisory Services and University Counsel in the development of policies and interpretation of statutes, policies, regulations, and guidance
• Coordinates with Information Technology in the development and implementation of monitoring reports
• Convenes and facilitates activities of the Conflicts of Interest Committee and serves as a member on the Data Stewardship Committee, Institutional Biosafety Committee, and Patent Committee

Research Compliance 60%

• Implements the institution’s Conflict of Interest Policy, ensuring that employees complete annual disclosures, developing management plans when required, and convening annual review boards to ensure continued compliance with approved management plans.
• Implements the institution’s Conflict of Commitment and External Professional Activities policy, ensuring that employees complete disclosures as needed, creates trainings for both the submission and approval process, and updates policies as necessary.
• Oversees the development, management, and evaluation of a university-wide research ethics and compliance program and strives to create an organizational culture committed to both ethically appropriate and legally compliant research conduct.

The Director ensures the Responsible Conduct of Research program is implemented following federal and university regulations.

Monitors existing research ethics and compliance activities and manages the procedures by which the institution responds to allegations of investigator non-compliance or unethical behavior.

All allegations of research misconduct are routed through this position, and the Director / Research Integrity Officer (RIO) orchestrates, facilitates, and provides consultation on required inquiries and investigations, ensuring due process required by institutional and federal policies.

Oversees the development, implementation, and management of a university wide export control compliance program and provides training and advice to the administration, employees, and students regarding export matters.

The Director ensures the compliance program addresses all applicable export control laws, regulations, and requirements, including, but not limited to, Export Administration Regulations, International Traffic in Arms Regulations, and the Office of Foreign Assets Control Regulations.

Oversees the development, implementation, and management of a university-wide research security compliance program and provides training and advice to the administration, employees, and students regarding research security matters.

The Director ensures the research security program addresses all applicable research security laws, regulations, and requirements that pertain to ECU and update policies and training as needed.

Contingent upon availability of funds. Minimum Education / Experience

• Post-baccalaureate education in a relevant scientific, health care, or administration / management discipline
• Knowledge of federal regulatory requirements regarding research including human subjects, animal welfare, conflicts of interest, research ethics and misconduct;
• 7 years of progressive experience in administration of research compliance programs

License or Certification Required by Statute or Regulation None Preferred Experience, Skills, Training / Education Experience in the following :

• At least 10 years of progressive experience in administration of research compliance programs
• Overseeing research compliance programs at a major research institution or within a healthcare environment; working knowledge of research administration management systems, such as COI Risk Manager, InfoEd, etc.
• working with faculty and staff to address, manage, and / or resolve conflicts of interest, conflict of commitment, research misconduct, or other incidences of noncompliance;

developing and delivering Responsible Conduct of Research training

• Serving as Research Integrity Officer for or participating on research misconduct cases, seeing them through to their conclusion (federal experience a plus);
• working knowledge of federal regulations on Export Controls; serving on biomedical and social sciences IRBs; supporting, monitoring, or administering clinical trials;

supporting clinical practice or clinical research

Previous supervisory experience.

Special Instructions to Applicant East Carolina University requires applicants to submit a candidate profile online in order to be considered for the position.

Candidates must also submit a cover letter, resume, and a list of three references, including contact information, online.

2-3 original letters of reference are required for employment. Please be aware that if selected as a candidate of choice, an automatic e-mail will be sent to the individuals entered by the applicant in the References section in the PeopleAdmin applicant tracking system.

Letters of reference submitted via the PeopleAdmin applicant tracking system will be verified and considered towards meeting this requirement.

Applicants must be currently authorized to work in the United States on a full-time basis. Additional Instructions to Applicant In order to be considered for this position, applicants must complete a candidate profile online via the PeopleAdmin system and submit any requested documents.

Additionally, applicants that possess the preferred education and experience must also possess the minimum education / experience, if applicable.

Job Open Date 09 / 06 / Open Until Filled No Job Close Date - Positions will be posted until 11 : 59 p.m. EST on this date.

If no closing date is indicated, the position may close at any time after the initial screening date. 09 / 27 / Initial Screening Begins 09 / 20 / Rank Level