University Classification: Application Analyst
Job Code: PRD1
Pay Level: 3A
Position #: 00226999
Org/Dept/Sub-dept #: 04-0213
Position Reports to: Kela Lewis
Position #00223778

Position Specific Summary:

The Human Subjects Office (HSO) at the University of Iowa is seeking an IRB Application Analyst to provide administrative assistance and expertise for the human subjects protection programs and services administered by HSO. To coordinate the activities and interactions among the UI Institutional Review Boards (IRB), other University committees, and UI investigators. This position may coordinate procedures and programs to enhance investigator compliance with the IRB application process and attend IRB meetings to document the discussion of regulatory determinations.

Key Areas of Responsibilities and Specific Job Tasks

Classification
Key Areas of Responsibility

Specific Job Duties and Tasks

Review of Research Applications

· Conduct thorough review of IRB applications to ensure that federal and university requirements for application content and informed consent documents are met.

· Communicate with researchers and IRB contacts to ensure accuracy and compliance with IRB agreements and university policies.

· Participates in resolving issues involving research ethics/compliance.

· Complete a prescreen or review of IRB submissions as assigned including: content-based review of research project application materials, focusing on accuracy, completeness, and appropriate content, as well as compliance with federal and University policies and regulations. Avoids technical jargon as appropriate.

· Coordinate Full Board IRB meetings for the University of Iowa IRB's

· Coordinate and communicate with IRB members, investigators, and research coordinators.

Communication with Research Community

· Serve as liaison to the public, faculty, the UI IRB, other University committees, and research staff concerning inquiries or complaints requiring interpretation of federal regulations and accreditation and IRB policies and procedures.

· Work with study teams regarding UI HRPP review requirements

· Coordinate communications with IRB contacts to ensure UI HRPP requirements are satisfied

· Works with others to address critical issues, resolves problems, and persuade or influence toward appropriate resolutions.

Regulatory

· Serve as a back up to coordinate assignments, materials, and set up of IRB meetings in compliance with federal regulatory and accreditation requirements.

Administrative

· Serve as back-up as needed for other positions in the HSO.

· Assist in coordinating meetings for senior HSO staff and assist in coordinating special programs, webinars, meeting scheduling, or workshops for the HSO.

· Attend IRB meetings as needed and document the discussions and determinations of the IRB for protocols reviewed at full board IRB meetings.

Education

· Develops materials for website

Data Management / Reporting

· Serve as technical expert on the use of the HawkIRB data management system and the IRB application process including interaction with research investigators, staff, and others through phone, fax, letter, email, HawkIRB workflow, or in person.

· Maintain corresponding IRB databases and records.

· Identify and recommend application database enhancements for tracking and reporting research projects.

Human Resources and Financial Management

· May provide functional supervision over student employees.

Universal Competencies

Collaboration/Positive Impact

Ability to work with a variety of individuals and groups in a constructive and civil manner and utilize existing resources and learning to achieve or exceed desired outcomes of current and future organizational goals/needs.

Diversity, Equity and Inclusion

Ability to work with a variety of individuals and groups in a constructive and respectful manner while appreciating the unique contribution of an inclusive workforce that brings together the talents of people across multiple identities, including: race, creed, color, religion, national origins, age, sex, pregnancy, disability, veteran or military status, sexual orientation, gender identity, or associational preferences.

Service Excellence/Customer Focus

Ability to meet or exceed customer service needs and expectations and provide excellent service in a direct or indirect manner. Ability to effectively transmit and interpret information through appropriate communication with internal and external customers.

Technical Competencies

Accuracy and Attention to Detail

(Working)

· Processes detailed information with good accuracy.

· Utilizes specific approaches and tools for checking and cross-checking outputs.

· Develops and uses checklists to insure that information goes out error-free.

· Accurately gauges the impact and cost of errors, omissions, and oversights.

· Learns from mistakes and applies lessons learned.

Communicating for Effective Relationships

(Working)

· Demonstrates an understanding of alternative points of view.

· Explains issues in alternative ways to accommodate different listeners.

· Demonstrates both empathy and assertiveness when communicating a need or defending a position

· Employs appropriate methods of facilitating collaborative communication.

· Works with others to address critical issues, resolves problems, and persuade or influence toward appropriate resolutions.

Data Gathering & Reporting

(Working)

· Participates in projects to gather data for needs analysis.

· Customizes data fields to meet clients' needs.

· Interprets and explains results of a data-gathering initiative.

· Assesses common problems and obstacles surrounding data-gathering.

· Detects and summarizes patterns in data and findings by producing simple reports.

Research Ethics / Compliance

(Basic)

· Explains the rationale and importance of basic research ethics and compliance requirements.

· Gives examples of proper and improper behavior.

· Able to locate applicable IRB regulations.

· Recognizes ethical/compliance requirements within own area of responsibility

Problem Solving

(Working)

· Uses fact-finding techniques and diagnostic tools to identify problems.

· Identifies and documents specific problems and resolution alternatives.

· Develops alternative techniques for assessing accuracy and relevance of information.

· Helps to analyze risks and benefits of alternative approaches and obtain decision on resolution.

· Examines a specific problem and understands the perspective of each involved stakeholder.

Organizational Savvy and Politics

(Working)

· Identifies key players, decision makers, and stakeholder's relevant to own team or function.

· Builds network of contacts in relevant other functions and departments.

· Obtains and shares information with appropriate stakeholders in other areas.

This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his or her supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of similar kind or level of difficulty.

As part of performing the key areas of responsibility and competencies described above, staff members are expected to meet reasonable standards of work quality and quantity, as well as expectations for attendance established by their supervisor. Staff members are also expected to comply with policies governing employee responsibilities and conduct, including those contained in the University Operations Manual.

Proficiency levels are defined as: 

Basic Application - Uses basic understanding of the field to perform job duties; may need some guidance on job duties; applies learning to recommend options to address unusual situations.

Working Experience - Successfully completes diverse tasks of the job; applies and enhances knowledge and skill in both usual and unusual issues; needs minimal guidance in addressing unusual situations.

Extensive Experience - Performs without assistance; recognized as a resource to others; able to translate complex nuances to others; able to improve processes; focus on broad issues.

Expert/Leader - Seen as an expert and/or leader; guides, troubleshoots; has strategic focus; applies knowledge and skill across or in leading multiple projects/orgs; demonstrates knowledge of trends in field; leads in developing new processes.

Position Qualifications

Education or Equivalency Required

Bachelor’s degree in an appropriate field, or an equivalent combination of education and experience.

Required Qualification

· Research Compliance: Demonstrates basic level of proficiency regarding the submission of human subject’s research applications and Informed Consent documents to an Institutional Review Board (IRB) in compliance with federal regulations.

· Problem Solving: Demonstrates working level of proficiency identifying problems and obtaining resolution alternatives.

· Accuracy and Attention to Detail: Demonstrates working level of proficiency processing information with good accuracy. Evidence of attention to detail and strong organizational skills.

· Communicating for Effective Relationships: Demonstrates working level of proficiency in facilitating collaborative communication and working well with others in a professional environment.

· Service Excellence/Customer Focus: Demonstrates working level of proficiency listening to feedback and adding value to customer interactions.

· Regulatory: Experience in writing correspondence to a federal regulatory agency.

Desirable Qualification

· Working knowledge of university policies and federal regulations regarding the protection of human subjects in research.

· Technical experience with an electronic research application database or other data management system or electronic workflow system.

See requisition # 21003060 at https://jobs.uiowa.edu

Applicable background checks will be conducted.

The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.