University Classification: Application Analyst
Job Code: PRD1
Pay Level: 3A
Position #: 00164166
Org/Dept/Sub-dept #: 04-0213-00000
Position Reports to: Mark Brunt
Position #00116481

Position Specific Summary:

The Human Subjects Office (HSO) at the University of Iowa is seeking a Commercial and External IRB Coordinator. Providing administrative assistance and expertise for the human subjects protection programs and services administered by the Human Subjects Office (HSO). Pre-screen Institutional Review Board (IRB) applications utilizing a single IRB model or external IRB to provide initial review. Assist with coordination of the activities and interactions with the Institutional Review Boards (IRB), other University committees, and UI investigators.

Key Areas of Responsibilities and Specific Job Tasks

Classification
Key Areas of Responsibility

Specific Job Duties and Tasks

Review of Research Applications

· Perform review of application materials utilizing a commercial or external IRB to ensure university requirements for application content and informed consent documents are met.

· Perform review of application submissions (including HSRD forms, new projects, continuing reviews, modifications, closure notices, and reportable event forms as assigned) set up to serve as a single IRB of record to ensure that federal and university requirements for application content and informed consent documents are met.

· Review applications with non-University of Iowa research team members. 

Communication with Research Community

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

· Interact with regulatory committee members, UI Committees, principal investigators, research team members, outside agencies and the public regarding application processing, preparing application materials, general inquiries, complaints, and the use of electronic databases for commercial or external IRB submissions.

Regulatory

· Assist with coordinating regulatory committee meetings in compliance with federal/state regulatory requirements. Interpret and apply federal/state regulations and University policies.

· Able to locate and apply human subjects research\IRB regulations.

Administrative

· Make decisions and exercise a level of autonomy while typically performing administrative support for executives of an organization (e.g., Director, Program Managers, Administrators, Supervisors, or IRB Chairs), including managing correspondence and schedules for special programs, webinars, or workshops.

· Review, revise, and develop office procedures. 

· Maintain report processing for a variety of reports from the electronic research application system (HawkIRB).

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

Education

· Assist with the development and revision of departmental informational materials for distribution to HSO staff related to the external IRB processes.

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, HawkIRB workflow, email (uirb-external@uiowa.edu and uiwirb@uiowa.edu) or in person.

· Assist with maintaining external IRB corresponding databases and records.

· Complete reporting on various review states of IRB applications.

· Maintain records. Prepare and monitor summary reports as needed.

· Other reporting duties as assigned.

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)

· Understanding of the necessity and value of accuracy and attention to detail; ability to process information with high levels of accuracy.

· 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)

· Knowledge and application of the communication techniques and relationship building skills that develop the ability to work with a variety of individuals and groups in a constructive and collaborative manner. 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.

Research Ethics/Compliance

(Basic)

· Knowledge of practices, behaviors, applicable laws, rules, and regulations governing proper research conduct; ability to demonstrate ethical and compliant behavior in diverse situations.

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

· Gives examples of proper and improper behavior.

· Able to locate applicable IRB, IACUC, etc. regulations.

· Recognizes ethical/compliance requirements within own area of responsibility.

Problem Solving

(Working)

· Knowledge of approaches, tools, techniques for recognizing, anticipating, and resolving organizational, operational or process problems; ability to apply this knowledge appropriately to diverse situations.

· 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.

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

· Some (6 months - 1 year) related administrative and program coordination experience.

· Experience in research administration or conducting research involving human participants.

· Demonstrated problem solving ability including identification of problems and obtaining resolution alternatives.

· Evidence of strong attention to detail, excellent communication, and strong organizational skills.

· Demonstrated ability to communicate and work well with others in a professional environment.

· Evidence of providing excellent customer service.

Desirable Qualification

· One or more years' experience conducting research involving human participants, or in a related administrative role supporting human subjects research OR One or more years' experience working with federal regulations.

· Knowledge of University policies, procedures, and regulations.

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

See requisition # 21001418 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.