Additional Info

General Position Information


Department Name: Compliance UNOWorking Title: Director of Research Compliance
Holder Name: Brenda L KolobaraFLSA Designation: Exempt - Administrative Professional
FTE: 

Position Description Details


Responsibilities and Duties


RESPONSIBILITYTIME SPENT PERCENTAGEESSENTIAL FUNCTIONTASKS
Manage Research Integrity & Regulatory Compliance Issues65X

  • Provide leadership and oversight pertaining to compliance with all federal, state, local, and internal policies governing university-based research activities. Responsible for ensuring that current university policies and procedures are sufficient to minimize and prevent the risk of non-compliance. In addition, continuously monitor developments in federal, state, and local regulations and develop and implement new policies, procedures, training, and monitoring programs as needed to remain in compliance with evolving regulations.
  • Anticipate, manage, and monitor compliance with the regulatory requirements that pertain to the research enterprise, and work with the faculty, senior leadership and central and college administrators to enhance research compliance efforts in all related areas including such areas as protection of human subjects, animal care and use, conflict of interest, research ethics, research misconduct, research data and privacy, export controls, and hazardous materials.
  • Ensure that all faculty, staff, students, and affiliates comply with Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), Office of Foreign Assets Control (OFAC) regulations and all other applicable export control or sanction related regulations, including deemed exports/export controls, excluded parties/sanctions, and screenings related to research and international travel. Responsible for International Research Compliance Review, including review and approval of international travel and international agreements for export control compliance.
  • Direct and assist the University in meeting its ethical and regulatory obligations for the protection of human participants in research, act as a liaison and work collaboratively with the UNMC/UNO Institutional Review Board. Direct growth and expansion of UNO#s review of human subject research protocols, including the potential development of an independent Institutional Review Board (IRB).
  • Direct and assist the University in meeting its compliance obligations for the animal care and use program, and act as a liaison and work collaboratively with the UNO Institutional Animal Care and Use Committee (IACUC).
  • Ensure compliance, act as a liaison, and work collaboratively with the UNMC/UNO Institutional Biosafety Committee.
  • Direct and oversee compliance research data and privacy, and related research security requirements. This role requires close cooperation and coordination with multiple offices with operational responsibility for these activities.
  • Coordinate internal compliance review and monitoring activities, including periodic reviews of policies and programs, manage investigation of matters related to research integrity and compliance, including the design and coordination of internal investigations, assisting with University responses to compliance violations, and any resulting corrective actions.
  • Design and implement a proactive compliance review process to assist with monitoring and maintaining compliance with any and all state and federal regulations applicable to the department or areas reviewed.
  • When necessary, review proposals, contracts, and awards for University, federal and/or state compliance issues or sensitivity concerns and recommend appropriate action.
  • Prepare and submit reports related to research integrity and compliance.
  • Identify needs, develop, draft, and implement new research integrity and compliance policies and procedures.
  • Develop and implement a communication strategy regarding relevant research integrity and compliance issues and audit information.
  • Maintain accurate and comprehensive records of research integrity and compliance activities as necessary to comply with appropriate regulations.
  • Direct and lead the Research Compliance Program, to implement and maintain standards essential for the conduct of legal and ethical research.
  • Oversee compliance staff activities, including the assignment of goals and tasks, and the successful completion of the same. Hire, train, supervise, develop, support, and evaluate compliance team members.
  • Work closely with UNO#s Office of Sponsored Programs to ensure compliance with regulatory requirements to which grants and contracts are subject to and to confirm that all pre-award activities are handled accordingly.
  • Provide review and guidance for certain legal contracts, awards, MOUs, data use agreements, and subawards, as needed.
Promote Ethical Leadership & Research Integrity35X

  • Provide strategic oversight for and coordination of institutional research compliance programs that promote a culture of compliance and the highest standards of ethics, integrity and responsibility within the University community.
  • Develop a culture of regulatory compliance and research integrity through the establishment or enhancement of procedures, education, strategic risk assessments, audits, and other monitoring processes.
  • Develop, execute, and monitor an effective research integrity and compliance program and, if necessary, institute corrective measures to ensure compliance with policies, activities and procedures related to internally and externally sponsored grant and contract award requirements.
  • Oversee compliance matters including responsible conduct of research (NSF and NIH); financial conflict of interest (FCOI) (NSF and NIH); research integrity and misconduct. The Director responsible for research related FCOI determinations, management plans, and reporting to federal agencies, as required.
  • Provide leadership and oversight in maintaining compliance infrastructure for research integrity.
  • Provide guidance and consultation to students, staff, faculty, and administration on research integrity and compliance issues.
  • Perform other relevant duties as required or assigned.


Zone Definition Factors


Knowledge Skills and Abilities


  1. Knowledge of, and/or experience with, managing research integrity and compliance in a university research setting.
  2. Experience managing and overseeing research integrity and compliance program execution, including research related investigations.
  3. Experience in the study and interpretation of legislation, regulations, policies, procedures, and ethical principles in research compliance and legal compliance, including excellent reading comprehension.
  4. Ability to translate regulations into operational policies and procedures.
  5. Skilled in managing sensitive and confidential information and materials in accordance with organizational policies.
  6. Demonstrated ability to undertake and effect meaningful change in a research compliance area.
  7. Experience managing and supervising a team of compliance professionals; ability to establish performance standards for designated programs and/or areas of specialization, and direct staff to include hiring, discipline, transfers, promotions, and salary changes.
  8. Demonstrated ability to serve as a key resource for research compliance questions concerning the interpretation of policies and their application to individual circumstances.
  9. Experience working with leadership to develop policy, procedures, and standard work to support the conduct of research functions.
  10. Ability to manage research conflicts of interest and conflicts of commitment, including directing and convening meetings for the Conflict of Interest Review Committee (CIRC).
  11. Knowledge of and experience with overseeing, guiding, educating, and directing administrative processes for researchers in areas of research compliance which includes human subjects, animal subjects, responsible conduct of research, conflict of interest, conflict of commitment, biosafety compliance, export control, allegations of research misconduct, and other research related compliance areas.
  12. Ability to identify and communicate research compliance related risks to key stakeholders, as well as proven track record mitigating those risks and validating internal controls are operating as intended.
  13. Strong oral and written communication skills, facilitation skills, and interactive skills, and an ability to work with diverse constituencies within an academic community as well as with external constituents.
  14. Ability to independently assess potential impact and consequences of research integrity and compliance and legal compliance requirements and obtain the best possible outcome for UNO.
  15. Demonstrated ability to undertake and effect meaningful change in a research compliance area.
  16. Demonstrated expertise in developing standard operating procedures.
  17. Strong attention to detail and proven track record of following through on details.
  18. High degree of professionalism, personal integrity, and ethics with uncompromising standards.
  19. Ability to work in a fast-paced, deadline-driven environment.
  20. Ability to take initiative, work independently, and maintain confidentiality.
  21. Ability to exercise discretion and creativity where no clear precedent exists.
  22. Ability to work effectively as part of a team and to reconcile differing viewpoints.
  23. Outstanding skills with word processing and spreadsheet computer software packages, including Microsoft Office suite.


Problem Solving - Decision Making


Utilizes independent judgment to make and execute decisions that may have a significant impact on a large number of individuals.

Must have the ability to 1) assess and interpret research compliance and legal compliance requirements and contract terms and conditions and problem solve by critically evaluating consequences and appropriate courses of action and 2) arrive at solutions that are best for the UNO campus community while demonstrating a strong customer service commitment.

Decisions and problem resolutions require analysis and evaluation of major issues and courses of action impacting the overall direction of the functional area(s). Applies broad concepts and experience in making important decisions. May develop recommendations influencing long-term policies related to major organizational plans.


Impact


Actions and decisions made by the Director exert a broad and continuing impact on the future of one or more functional areas. The Director has a major impact on decisions and final results affecting university activity; and/or has accountability for financial and program/project objectives and overall successes. Errors significantly interrupt business operations, services and potentially impact both internal and external constituents.


How quickly is the overall correctness of the work of an incumbent in this position typically determined?:

Determined within a relatively short period of time


Interactions


Regular interaction with a wide variety of ethnically and culturally diverse constituents, including UNO administrators, faculty and staff, as well as external representatives from academia, industry, and government. Interactions involve the dissemination of information regarding the research integrity and compliance program to the UNO community. Interactions will also involve the negotiation of contractual terms and conditions, the exchange of advice and opinions, and the conveyance of conceptual ideas of a critical and/or long-range nature. Interactions require the use of sound judgment, timing, and persuasion in a professional manner to gain collaboration and consensus.


Supervision Received


Extensive latitude to work independently in matters that have a broad effect on overall policies, programs and/or areas of specialization. [4]


Supervision Exercised


Does this position supervise?:

Yes


What types of employees do you supervise?:

Managerial/ Professional


Type of Supervision Exercised:

Establishes performance standards for designated programs and/or areas of specialization. Directs staff to include hiring, discipline, transfers, promotions, and salary changes. [4]


Work Environment & Physical Demands


Working Environment


Office


If Other/Combined Environment, please explain:

N/A


Activity Frequency


Sit: Frequently (34-66%)Bending: Occasionally (1-33%)
Stand: Occasionally (1-33%)Kneeling: Occasionally (1-33%)
Walk: Occasionally (1-33%)Reaching: Occasionally (1-33%)
Drive Motor Vehicle: Not RequiredCrawling: Not Required
Squatting: Occasionally (1-33%)Climbing: Not Required

Lift, Carry, Push, Pull Activity


Lift: Occasionally (1-33%)  11 - 20 lbsPush: Occasionally (1-33%)  11 - 20 lbs
Carry: Occasionally (1-33%)  11 - 20 lbsPull: Occasionally (1-33%)  11 - 20 lbs

Use of Protective Equipment


Hearing Protection: NOEye Protection: NO
Half or Full Face Reusable Respirator: NOProtective Clothing: NO

Use of Hands/ Wrists


Keyboard: YESPipefitting: 
Fine Manipulation: YESGrasping: YES
Repetitive Motion: YES