Item 9.G-April 11, 2014
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 Faculty HR at 682-6114
INSTRUCTIONS: See http://www.unr.edu/hr/compensation-and-evaluation for complete instructions.
Incumbent(s) Name (if applicable): Michelle Hoyt Johnson
Position #(s): 17693
Current Title: Compliance/Quality Improvement Officer
Current Range: 3
(JCC:67070 )
Department: Office of Human Research Protection
College/Division: Vice President,
Research and Innovation
Account #(s): 1204-121-0833
Action Proposed: (check all that apply)
( ) New position: Proposed Range:
Proposed Title:
( ) Title Change, Proposed Title:
( ) Proposed Reassignment from Range
to Range
(X) Revised PDQ only (no change in range or title)
( ) Line of Progression (show titles below)
Range:
JCC (Current
or new 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 Nancy Moody, OHRP Special Projects
__________________
Date
____________________________________________________________
Director/Chair/Dean
__________________
Date
Approved for Salary Placement Committee review.
____________________________________________________________
__________________
Pres / Vice Pres / Vice Prov Signature Mridul Gautam
Date
Vice President, Research and Innovation
Action Approved by the Provost/President (Completed by Faculty HR):
67070 Range:
3
Pos #(s): 17693
JCC:
EEO: 3D
Eff: 4/1/2014
Approved Title: Compliance/Quality Improvement Officer
Employee signs on “final” stamped approved PDQ and sends to HR for personnel file.
Employee Signature:_______________________________________________ __________________
Date
Printed Name: ____________________________________________________
Rev: 10/1/2012
Position Description – Compliance and Quality Improvement Officer
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 Compliance/Quality Improvement Officer serves as the statewide auditor in the University of
Nevada, Reno (UNR) Office of Human Research Protection (OHRP), a regulatory compliance office
that reports directly to the Vice President for Research and serves the University research community,
including the University of Nevada, Reno (UNR), University of Nevada School of Medicine (UNSOM)
(statewide), the Veterans Administration Sierra Nevada Health Care System (VA SNHCS), Truckee
Meadows Community College (TMCC), Desert Research Institute (DRI) and other entities as
contracted. The individual is responsible for the development, implementation, and accountability of
the Quality Assurance/Quality Improvement Program for the University’s human research protection
program for all human subjects’ research and travels regularly.
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).
40% - IRB and OHRP Quality Assurance and Improvement
 Develop, implement, and assume accountability of the OHRP Quality Assurance/Quality
Improvement Program
 Develop procedures, processes and documentation to support the audit process
 Conduct Institutional Review Board (IRB) departmental quality assurance reviews and
continuous quality improvement including review of all protocol renewals
 Train OHRP staff in accurate record keeping, content of protocol files, and regulation
compliance, and provide guidance for correction when errors are found
 Assist investigators in understanding regulatory requirements, identify areas for improvement
and suggest recommendations
 Assist with Accreditation of Human Research Protection Programs (AAHRPP) process, as
requested by Director
 Assist with IRB protocol reviews as assigned by the director
30% - Institutional Audits and Compliance
 Conduct directed (“for cause”) audit and compliance reviews on research investigators using a
systematic method to assess compliance with federal, state, and local law and Nevada
System of Higher Education (NSHE) and UNR policies with results reported to the Director
and the Chair of appropriate IRB
 Conduct (“not for cause”) compliance reviews by random selection of subjects and using a
systematic method to review IRB approved research and IRB records/activities to demonstrate
the importance of the safety, rights and welfare of study participants and to assess investigator
compliance with federal, state, and local law and NSHE and UNR policies with results reported
to the Director and the Chair of appropriate IRB
30% - Non-Institutional Audits and Compliance
 Conduct external directed (“for cause”) audit and compliance reviews at non-UNR sites where
the university’s IRBs serve as the “IRB of Record”, using a systematic method to assess
compliance with federal, state, and local law and NSHE and UNR policies with results reported
to the Director and the Chair of appropriate IRB for appropriate IRB determination
Position Description – Compliance and Quality Improvement Officer

Page 3
Conduct IRB external (“not for cause”) compliance reviews by random selection of subjects
and using a systematic method to review IRB approved research and IRB records/activities to
demonstrate the importance of the safety, rights and welfare of study participants and to
assess investigator compliance with federal, state, and local law and NSHE and UNR policies
with results reported to the Director and the Chair of appropriate IRB
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 incumbent must make independent choices, determinations, and judgments regarding human
research compliance with current regulations and procedures. The incumbent must independently
determine if compliant research is being conducted according to federal, University, FDA, and VA
regulatory and ethical guidelines with respect to the protection of human subjects in research. The
issue of non-compliance with human subject protection by researchers is extremely sensitive, must be
handled in a confidential manner, and may involve results being sent to federal regulatory agencies.
Findings are reported to the Director for communication with institutional officials.
Impact:
The QA/QI Program is important to finding and fixing IRB-related problems. The absence of such a
program can negatively impact the University including a potential for loss of federal funds. If noncompliance is found, sanctions may be imposed on the researcher which may involve loss of funding
for a study, damage to the researcher’s reputation, and/or loss of research privileges at the institution
of record. Inappropriate determinations on how to handle infractions can negatively impact the
University’s ability to protect human subjects from research risks and have other serious implications
for the University.
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:
 Federal regulations and practices pertaining to human subjects’ research protection to include
Department of Health and Human Services (DHHS), U.S. Food and Drug Administration
(FDA), and Department of Veterans Affairs (DVA)
 Federal DHHS office for Human Research Protections’ IRB Guidebook
 University’s Federal-wide Assurance of Compliance with DHHS Regulations on the Protection
of Human Subjects
 AAHRPP Accreditation Standards
 Health Insurance Portability and Accountability Act (HIPAA) Private Rule
 Guidelines for Good Clinical practice; Belmont Report; Declaration of Helsinki; Nuremberg
Code
 Council for International Organizations of Medical Science (CIOMS)
 International Council on Harmonization
 Nevada Revised Statutes which include mandatory reporting of occurrences of child and elder
abuse and injury to self
 Scope of human biomedical research
Position Description – Compliance and Quality Improvement Officer
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Skills:
 Documentation of process, data sources and procedures
 Excellent planning and organizational skills
 Proficiency in use of a personal computer and current software applications including but not
limited to Microsoft Office Suite (Word, Access, Excel, PowerPoint, and email)
 Strong interpersonal skills with the ability to work independently, as part of a team, and
harmoniously within a diverse community
 Analytical, decision-making, and problem-solving skills
 Excellent verbal and written communication
Ability to:
 Manage, prioritize, and complete multiple projects/tasks
 Manage sometimes stressful and adversarial situations
 Interpret and apply the Federal regulations and practices pertaining to human subjects’
research protection
 Quickly learn and adapt to rapidly changing technology, administrative regulations and policies
 Maintain confidentiality of information
 Lift up to 25 pounds (computer hardware/protocol file boxes)
 Travel statewide approximately 25% of time
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 research, teaching
and administrative faculty, staff,
and students
IRB Board Members
Office of Sponsored Projects
Administration
Graduate School staff
UNSOM Compliance Officer
External
National conferences
Federal OHRP, FDA, DVA
Federal, state, local and industry
sponsors and affiliated
institutions
Institution officials/compliance
officers
Entities for which university
provides IRB services
Reason for Contact
To provide technical support and conduct compliance audits and
reviews; provide education regarding compliance issues and
protocol process
To ensure compliance with federal regulations and guidance,
University policy and IRB guidelines
To ensure funded research has approved human subjects
protocols on file
To ensure that graduate student thesis/dissertation research using
human subjects has approved protocols
To coordinate actions and conduct reviews for compliance
Reason for Contact
To attend conferences on human subjects research administration
to accomplish educational and professional networking goals
To coordinate and answer to audits and reviews
To ensure that research using human subjects is approved or is
compliant
To audit for compliance and to discuss non-compliance issues and
resolution
To provide IRB services
Position Description – Compliance and Quality Improvement Officer
Page 5
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.
Bachelor’s Degree (or Master’s Degree or Doctorate Degree) from a regionally
accredited institution (with emphasis or major in)
b.
Minimum type and amount of work experience, in addition to the above required
education necessary for a person entering this position.
Bachelor’s Degree from a regionally accredited institution
Preferred Licenses or Certifications: None
c.
Indicate any license or certificate required for this position.
None