Item 9.E-April 20, 2012
ADMINISTRATIVE FACULTY POSITION DESCRIPTION QUESTIONNAIRE
To expedite and facilitate the PDQ review process, please send the PDQ and Org Chart electronically to
marshag@unr.edu for discussion and for initial review before routing PDQ for approval signatures.
Questions - call UNR-HR at 682-6114
*******************************************************************************************************************
INSTRUCTIONS: See http://www.unr.edu/vpaf/hr/compensation/placement.html for complete instructions.
*******************************************************************************************************************
Incumbent(s) Name (if applicable): Nancy Moody
Position #(s): 11225
Current Title: Director, Office of Human Research Protection
Current Range: 5
(JCC:76065;1B;CM3535;CC023;E)
Department: Office of Human Research Protection
Account #: 1204-121-0833
Action Proposed: (check all that apply)
( ) New position: Proposed Range:
Proposed Title:
( ) Title Change, Proposed Title:
(x) Proposed Reassignment from Range to Range
(X ) Revised PDQ only (no change in range or title)
( ) Line of Progression (show titles below)
College/Division: Vice President, Research
Range:
JCC (HR assigned):
I certify that the statements in this description are accurate and complete to the best of my knowledge.
____________________________________________________________
Employee’s Signature
__________________
Date
I/we have reviewed the statements in this form and they accurately reflect the job assignments.
____________________________________________________________
Immediate Supervisor’s Signature
__________________
Date
____________________________________________________________
Director/Chair/Dean
__________________
Date
Approved for Salary Placement Committee review.
____________________________________________________________
__________________
Pres / Vice Pres / Vice Prov Signature Marsha Read
Date
Vice President, Research/Dean, Graduate School
Action Approved by the President (Completed by Faculty HR):
Position #: 11225
EEO Code: 1B
CUPA Code: CM3535
Exempt: Yes or No Census Code: 023
Job Class Code: 76065
Range: 5
Effective Date: 4/1/2012
Approved Title:
DIRECTOR, OFFICE OF HUMAN RESEARCH PROTECTION
____________________________________________________________
__________________
Employee Signature
Date
(Employee sign and send to HR for personnel file after PDQ approval for personnel file)
Rev: 12/1/2008
Position Description - Director, Office of Human Research Protection
Page 2
1. Summary Statement: State the major function(s) of the position and its role in the
university. Attach an organizational chart with positions, ranges, and names for the division
which reflects the position in it as well as those supervised in the department. (This section is
used for advertisement of the position.)
The Director of the Office of Human Research Protection (OHRP) is responsible for the leadership
and effective management of the University of Nevada, Reno (UNR) OHRP, direct management
responsibility for establishing and promoting objective standards for the implementation of the
University’s Conflict of Interest policy, and coordination and compliance standards for research
integrity. The position provides guidance to UNR officials, faculty, staff, and students with regard to
federal regulations, state and local laws, guidance and policies pertaining to the use of human
subjects in biomedical and social behavior research and the compliance with these requirements.
The Director serves as the University official for conflicts of interest and research integrity. The
position reports to the Vice President, Research / Dean, Graduate School.
2. List the major responsibilities, including percentage of time devoted to each. Provide
enough detail to enable a person outside the department to understand the job (percentage
first with heading and then bulleted information).
60% - Management of the OHRP
 Maintain institutional AAHRRP accreditation
 Serves as federally mandated Human Protections Administrator (HPA) a position dictated by
the Federal-wide Assurance (FWA) system
 Develop effective communication with users to facilitate continual quality improvement
 Establish affiliations with other institutions for IRB services as requested/needed
 Provide an environment conducive to ethical and compliant research by disseminating policies
and procedures to all researchers at the University
 Serve as the primary point of contact for internal and external inquiries or complaints regarding
research integrity and regulatory compliance involving human subjects
 Initiates all investigations and reports all incidents of noncompliance and keep University
administrators informed of compliance issues, audits, conflicts, and emergencies
 Facilitate and coordinate all federal audits, inspections, accreditation and site visits
 Recruit, hire, train, supervise, and evaluates the performance of OHRP staff, ensuring that
consistent compliance criteria are met and departmental operations and procedures are
maintained
 Design, develop and implement office operations and policy ensuring efficient workflow, office
communications, assessments and effective prioritization of assignments
 Develop and maintain an operating budget, including office supplies and services, travel to
national meetings, and computing needs for website management
 Develop and implement long-range plans for meeting the needs of the university research
community and current regulations and policies
15% - Management of Conflict of Interest Oversight
 Serve as the ethical conflict of research designated official for conflict of interest compliance
under federal and state laws and institutional policies
 Develop, recommend, implement, disseminate and maintain Conflict of Interest policy and
procedures for the University
 Develop, coordinate and direct education sessions/seminars for University personnel related
to conflicts of interest
 Coordinate campus wide annual Conflict of Interest disclosures
Position Description - Director, Office of Human Research Protection




Page 3
Review all conflict of interest disclosures; develop and review as needed appropriate conflict of
interest management plan
Coordinate meetings of the Conflict of Interest Committee
Prepare annual report to the Board of Regents on Compensated Outside Professional
Services/Consulting Activities
Develop and maintain website for disclosure of conflicts of interest as required under federal
regulations and related confidential documentation
10% - Management of Institutional Review Boards Oversight
 Act independently as voting member and primary reviewer on all of the University’s
Institutional Review Boards (IRBs)
 Act as resource to researchers to ensure that those documents comply with the federal
regulations
 Provides sole certification to the federal government and private sponsors that University
biomedical/clinical and social behavioral research is compliant with the laws and regulations
for human subject research protection
 Recruit and train new members for IRBs (including non-University affiliated members, i.e.
community members)
10% Research Integrity
 Serve as the Research Integrity Officer
 Accept and assess allegations of research misconduct and inquires
 Assign investigator and oversees investigations into allegations of research misconduct
 Establishes the administrative policies for responding to allegations of research misconduct
that comply with PHS regulation 42 CFR Part 93 and accepted institutional procedures
 Develop, coordinate and provide training and education materials to faculty and students
specific to responsible conduct of research and maintaining integrity in research
5% - VPR Division Projects
 Provide assistance to the Vice President for Research and/or Assistant Vice President for
Research on projects, as assigned
 Participate in campus committees and other service activities for the division
3. Describe the level of freedom to take action and make decisions with or without
supervision and how the results of the work performed impact the department, division and/or
the university as a whole.
Level of Freedom
The Director utilizes extensive professional judgment and expertise to train staff and IRB members on
appropriate pre-review and evaluation of biomedical/clinical and/or social behavioral research studies
for their potential risk to subjects. The incumbent applies detailed and oftentimes conflicting
regulations, policies, and procedures to ensure the University’s good standing with the government
and the private sector. Position requires sound professional judgment for dealing with non-compliance
issues related to human subject research protection, as well as the ethical conduct of
research/scientific misconduct. Director utilizes professional judgment and expertise to train faculty
and staff on conflict of interest, as well as train the members of the Conflict of Interest Committee.
These judgments must be made with minimal supervision. The position ensures that researchers
comply with conflict of interest policies and procedures and with appropriate management plans for
dealing with conflicts of interest situations. The position also ensures compliance with scientific
misconduct reporting regulations. This position is responsible for effective functional area
management, long-range planning for improvement of operational efficiencies and establishing
strategic direction for conflict of interest and conduct of research administration. This position grants
final approval to all human subjects’ research.
Position Description - Director, Office of Human Research Protection
Page 4
Impact:
The decisions made by the Director may critically impact research and the credibility and prestige of
the University and the Nevada System of Higher Education (NSHE). The position ensures that
compliance with Federal regulations and other applicable laws for the protection of human subjects in
research is morally, ethically, and legally correct which strengthens the standards and quality of the
University. In addition, if the requirements of the Assurance have not been satisfied, the Federal
government may impose severe penalties against the University. Possible criminal charges may be
filed, and/or federal funds awarded for research involving humans may be withdrawn. Most
importantly, failure to perform adequately and appropriately may result in the injury or death of human
research subjects. Successful accreditation will honor the University’s commitments with the Veterans
Affairs Sierra Nevada Health Care System (VASNHCS) and will validate the quality and prestige of
the University’s Human Research Protection Program. Failure to ensure compliance with conflict of
interest policies and procedures and scientific misconduct reporting regulations could result in loss of
Federal funding.
4. Describe the knowledge, skills (to include cognitive requirement and verbal and written
communication), and abilities (to include task complexity, problem solving, creativity and
innovation) essential to successful performance of this job (in bullet format).
Knowledge of:
 Role and function of an Office of Human Research Protection
 Scope of human research – social, biomedical, and educational
 Operational requirements pertaining to the management and implementation of a successful
human protections program
 Evaluation and reporting requirements for conflicts of interest to university, state, and/or
federal agencies
 Federal and state regulations and requirements for conflicts of interest
 Federal requirements for training in regard to ethics and research integrity
Skills:






Excellent verbal and written communication
Excellent decision-making, organizational, and planning and prioritization skills
Expert level of skill in problem resolution and team building
Excellent critical thinking and analytical skills
Excellent interpersonal skills
Effective coordination, implementation, and oversight with the legal requirements for Conflict of
Interest policies, guidance and training practices specific to research integrity and the
implementation of the institution’s policies and procedures for addressing allegations of
scholarly and research misconduct
Ability to:
 Apply the policies and guidelines from the University’s Federal-wide Assurance of Compliance
with DHSS Regulations on the Protection of Human Subjects; the UNR Policies and
Procedures for Human Research Protection; NSHE Board of Regents Handbook; UNR
Administrative Manual; UNR Faculty Handbook; Nevada Revised Statues which include
mandatory reporting of occurrences of child and elder abuse, and injury to self
 Establish and maintain effective relationships with individuals at various levels within a
research framework and between research communities.
 Adapt to situations
 Understand and interpret formalized policies, guidelines, rules and regulations
Position Description - Director, Office of Human Research Protection



Page 5
Certify regulatory compliance with the federal government regarding conflict of interest and
scientific misconduct
Provide training to researchers and UNR staff and students regarding Federal, state, and other
regulatory research compliance and ethics standards
Exercise sound judgment to make objective, fair, consistent decisions
5. Describe the type of personal contacts encountered in performing the duties of the job.
Explain the nature and purpose of these contacts: i.e., to provide services, to resolve
problems, to negotiate.
Internal
University researchers (including
teaching and administrative
faculty, staff, and students)
University administrators
IRB Chairs and IRB members
Research Division Directors and
Staff
Other UNR entities, as faculty
senate
NSHE System Administration
Office
External
Federal (DHHS, including the
FDA; DVA) administrators,
officials, inspectors,
accreditation and audit teams
Sponsors (both federal and
industry sponsors)
External Institutional officials (i.e.
VASNHCS, Washoe Medical
Center and University Medical
Center in Las Vegas) and staff
Community Members
Reason for Contact
To provide technical support as principal point of reference and
consultation on IRB issues and all training activities
To effectively facilitate compliant research and resolve any
problems or complaints that may arise
To serve as a resource regarding regulations and current
assurance/compliance issues
To coordinate with Office of Sponsored Projects Administration
(OSPA) staff regarding approved, pending, and renewal of
protocols on grant funded projects, various department directors
regarding potential management of conflict of interest
Interpret policy, create policy and procedure and inform campus of
services, resolve problems, and exchange information
Provide information for the Board of Regents regarding conflicts of
interest
Reason for Contact
To accomplish all regulatory compliance activities
To certify approved research and conduct protocol negotiations
To facilitate negotiation of regulatory agreements, foster
cooperative research or provide professional expertise
To provide training to new IRB members, interacting with subcontract recipients
6. Indicate the minimum qualifications which are necessary in filling this position should it
become vacant. Please keep in mind the duties/responsibilities of the position rather than the
qualifications of the incumbent.
a.
Minimum educational level, including appropriate field, if any.
Master’s Degree from a regionally accredited institution
Position Description - Director, Office of Human Research Protection
Page 6
b.
Minimum type and amount of work experience, in addition to the above required
education necessary for a person entering this position.
Master’s Degree and four years of experience in a complex administrative
environment, which includes public contact and implementing state and federal
regulations to include IRB-related regulations, and research integrity or conflicts of
interest.
Preferred Licenses or Certifications: Certified Research Administrator (CRA)
c.
Indicate any license or certificate required for this position.
Certification for IRB Professionals (CIP)