Item 8.E-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): Gwen Snow
Position #(s): 17175
Current Title: Program Manager, Institutional Review Board
Current Range: 3
(JCC:77773 )
Department: Office of Human Research Protection
College/Division: Vice President,
(OHRP)
Research and Innovation
Account #(s): 1204-121-0833
Action Proposed: (check all that apply)
( ) New position: Proposed Range:
Proposed Title:
(X) Title Change, Proposed Title: Program Manager, OHRP Special Projects
( ) Proposed Reassignment from Range
to Range
( ) Revised PDQ only (no change in range or title)
JCC (Current
( ) Line of Progression (show titles below)
or new HR
Range:
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, Director, OHRP
__________________
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):
67535 Range:
3
Pos #(s): 17175
JCC:
EEO: 3D
Eff: 4/1/2014
Approved Title: Program Manager, OHRP Special Projects
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 – Program Manager, OHRP Special Projects
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 Program Manager for OHRP Special Projects is tasked with researching and handling projects
relating to OHRP issues and topics. The Office of Human Research Protection (OHRP) is responsible
for ensuring federal regulation compliance and research integrity with regard to human subjects’
research of faculty and students at the University of Nevada, Reno and with external organizations in
the community. The position reports to the Director, OHRP.
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% - Special Projects
 Research and complete various assigned projects relating to OHRP programs
 Make recommendations on researched issues to Director
 Develop office policies and procedures
 Develop and implement training for OHRP related issues
20% - Human Research Protection Compliance Oversight
 Independently responsible for the implementation and management of human research
protection compliance oversight program, including but not limited to:
Institutional Audits and Compliance Reviews, e.g., conducts directed (“for cause”) audits and
periodic compliance reviews to assess the researcher’s compliance with Federal, State, and
local law, NSHE and University policies, identify areas for improvement, and suggest
recommendations based on existing policies and procedures
Non-UNR Audits and Compliance Reviews
o Periodic compliance reviews will be systematically conducted to review IRB-approved
research or IRB records/activities on a regular basis; the results are reported to the
Director and the Chair of the appropriate IRB
o If the incumbent finds that subjects in a research project have been exposed to
unexpected serious harm, the incumbent will promptly report such findings to the Director
and the Chair of the appropriate IRB
Internal Compliance Reviews, e.g., conducts internal directed audits and random internal
compliance reviews; results may impact current practices and may require additional
educational activities, and will report to the Director and the Chair of the appropriate IRB
IRB Departmental Quality Assurance Reviews and Continuous Quality Improvement, e.g.,
other aspects of internal compliance monitoring will be conducted by performing Quality
Assurance reviews and Continuous Quality Improvement activities
20% - Human Research Protection Administration
 Manage pending and approved protocols submitted to the IRBs
 Monitor conflict of interest issues related to human research studies
 Assist the Director in the development of institutional policy and procedures for the UNR Office
of Human Research Protection
Position Description – Program Manager, OHRP Special Projects
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 Serve as an ex-officio voting member of the Social Behavioral and Biomedical Institutional
Review Boards
 Independently manage the renewal process (continuing review) and closures of protocols in
accordance with federal regulations, the University federal-wide assurance of compliance, and
University policy
 Independently review IRB-mandated revisions of new and continuing protocols submitted for
approval to insure compliance with IRB requirements, federal regulations and policies and
University, state and local policies and statutes
 Certify approved research to sponsors or for affiliated institutions
 Prepare complex reports to submit to the IRB Chairs, the Director, and regulatory agencies
and departments according to the duties above and as required
 Acts as a voting member of the 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 Program Manager plays a pivotal role in the operation of the OHRP by assisting the Director in
the development, implementation, and management of human research protection activities in
protocol development, education, and compliance. The incumbent is assigned multiple work
assignments and projects and works independently within a framework of prescribed procedures. The
position determines appropriate methods, priorities and resources required when given an assignment
and makes recommendations to the Director who gives final approval. The incumbent organizes and
performs work on different tasks using established precedents and personal judgment. Tasks
performed require coordination and frequent reprioritization. The incumbent consults with the Director
on initial project assignment and then submits for final approval when completed. The position
consults with the Director on protocols with problems or issues of higher complexity or high visibility to
the University.
Impact:
The incumbent must independently convey to researchers the value and necessity of human research
protections by providing information and interpreting regularly requirements to ensure their
understanding and compliance. Failure to perform duties could have a negative impact on research of
students, faculty, and medical community as well as affect the reputation of 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:
 IRB review for human subjects research protocols
 Federal, state and local policies, statutes and guidelines related to human research protection
 Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
 Association for the Accreditation of Human Research Protection Programs (AAHRPP® )
Accreditation Standards
 Research methodologies and design, data collection, analysis, and interpretation of data
 Training and/or mentoring of staff
 Project management
Position Description – Program Manager, OHRP Special Projects
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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)
 Excellent verbal and written communication in order to explain and clarify protocol procedures
 Strong customer service skills
 Problem solving skills
 Time management skills in order to prioritize projects and meet deadlines
 Skill in both short- and long-term planning
 Supervisory skills in order to mentor and train lower level staff
 Both short- and long-term planning
Ability to:
 Interact with faculty and staff in a productive and tactful manner
 Exercise good judgment and maintain confidentiality of sensitive information
 Maintain a timely, consistent, consumer-oriented approach with customers and/or clients
 Work with diverse populations and be sensitive to gender, disabilities, and cultural and ethnic
diversity issues
 Stay current in discipline by seeking out and learning new information pertinent to performance
of duties
 Apply established rules and procedures and make decisions that affect quality, accuracy, or
effectiveness of results
 Collaborate effectively with colleagues and work as part of a team within an established office
structure
 Organize, analyze and synthesize complex technical information
 Understand and interpret formalized policies, guidelines, rules, and regulations
 Review and analyze, in detail, a large volume of technical paperwork rapidly and accurately
 Interpret and apply the Federal regulations and practices pertaining to human subjects’
research protection
 Interpret University, state and local policies, statutes and guidelines
 Provide relevant input to the policy development process
 Analyze and assess procedures, design, and recommend changes to improve efficiency
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
Grants and Contracts/OSPA
staff
Graduate School staff
University faculty, staff, and
students
IRB members
Reason for Contact
To provide technical support, i.e., direct the preparation of protocol
drafts, to confer on protocol revisions, and educate researchers
regarding compliance issues, and to provide compliance oversight
To insure funded research has approved human subjects’
protocols on file
To ensure that graduate student thesis/dissertation research using
human subjects has approved protocols
To provide/assist with the implementation of training workshops
regarding the protocol approval process and the necessity of
Institutional Review Boards within research communities
To ensure compliance with federal regulations and guidance,
University policy and IRB guidelines
Position Description – Program Manager, OHRP Special Projects
External
Affiliated researchers
Organizations governing human
research protection (e.g., federal
OHRP, the FDA, and the
Department of Veterans Affairs)
Federal, state, local, and
industry sponsors, as well
affiliated institutions
Sponsors
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Reason for Contact
To provide technical support, i.e. direct the preparation of protocol
drafts, to confer on protocol revisions, educate these researchers
regarding compliance issues, and to provide compliance oversight
To conduct audits and reviews
To ensure that research using human subjects is approved or is
compliant
To provide certification of IRB approvals and to negotiate the
content of legally effective consent forms.
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 from a regionally accredited institution
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 and four years, or a Master’s Degree and two year, of experience
in human research protection administration or clinical study coordination
Preferred Licenses or Certifications: None
c.
Indicate any license or certificate required for this position.
None