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 Page 3 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 Page 4 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 Page 5 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