Additional Info

General Position Information

Position Number: 00081125	Working Title: IRB Analyst I
Department Name: Office of Regulatory Affairs/IRB UNMC	Reports To Title: Asst Vice Chanc for Regulatory Affairs

Position Description Details

Responsibilities and Duties

RESPONSIBILITY	TIME SPENT PERCENTAGE	ESSENTIAL FUNCTION	TASKS
Human Subject Research Oversight	80	X	1. Pre-review research submitted for IRB review. (E) 2. Facilitate full IRB review per HRPP policies and federal regulations. (E) 3. Attend and participate in IRB meetings. (E) 4. Serve as a contact for investigators, coordinators, and other research staff for University of Nebraska Medical Center protocols to which he/she is assigned. 5. Write review letters, initially with oversight by senior IRB analysts and/or the IRB Executive Chair or designee. 6. Assist in performing expedited reviews of new protocols, continuing reviews, changes in protocol, and other actions, and when sufficiently experienced, be primarily responsible for these reviews. 5. When sufficiently experienced, serve as a voting member (or alternate member) of one or more of the IRBs.
Outreach and Other Departmental Duties	10	X	1. With support from senior IRB analysts and/or Executive Chair, meet with investigators and research staff to facilitate research and discuss individual research projects. 2. Provide general information (as appropriate) to stakeholders regarding HRPP policies and procedures. 3. Assist in the development and presentation (as appropriate) of educational materials for the research community.
Committee Assignments, Continuing Education, and Other Duties	5	X	1. Obtain a working knowledge of applicable federal regulations and guidance, HRPP policies, and ethical principles underlying human subject research. 2. Participate in on-line training, webinars, and in-person education to achieve and maintain competence as above. In consideration of ORA and institutional budgetary constraints, attend regional and/or national conferences. 3. Assist with other departmental initiatives and projects as required.
Support of Efficient and Effective HRPP Function	5	X	1. Assist in the development or revision of HRPP policies, procedures, forms, and checklists as necessary. 2. Participate in Quality Improvement activities of HRPP, including annual HRPP evaluations

Zone Definition Factors

Impact

How quickly is the overall correctness of the work of an incumbent in this position typically determined?:

Determined within a relatively short period of time

Include budget dollars, value of assets, and impact in terms of organizational exposure to risk/liability.

Describe the budgetary accountabilities for this position:

No budgetary accountabilities

What impact do the decisions/recommendations made by the position have on the department/campus?:

Failure to adequately perform the duties assigned to this position could result in sanctions by the federal government, return of grant funds, expensive litigation, and damage to the Institution’s reputation within the State of Nebraska and nationally. This could adversely affect patient referrals with significant economic consequences.

Failure to appropriately perform the duties assigned will increase the work load of others in the office, increase complaints about the IRB by investigators and the
general research community and hinder the conduct of human subject research in general.

Contacts and Communications

TYPE OF CONTACT	LEVEL OF CONTACT	FREQUENCY OF CONTACT	PURPOSE OF CONTACT
All UNMC and Nebraska Medicine departments conducting human subject research	All Levels of Contact	Daily	Liaison and information source for all issues pertaining to human subject research.
All UNO and Children#s Hospital & Medical Center departments conducting human subject research	External to UNMC	Daily	Liaison and information source for all issues pertaining to human subject research.
UNMC, Office of Regulatory Affairs, all staff	Internal to UNMC	Daily	All matters pertaining to the conduct of human subject research, specifically pertaining to Applications for Continuing Review.

Supervision Received

Bruce Gordon, Assistant Vice Chancellor for Regulatory Affairs

This position determines priorities approximately 26%-50% of the time.

Supervision Exercised

Does this position supervise?:

Type of Supervision Exercised:

Work Environment & Physical Demands

Working Environment

Office

Activity Frequency

Sit: Continually (67-100%)	Bending: Not Required
Stand: Occasionally (1-33%)	Kneeling: Not Required
Walk: Occasionally (1-33%)	Reaching: Occasionally (1-33%)
Drive Motor Vehicle: Not Required	Crawling: Not Required
Squatting: Not Required	Climbing: Not Required

If other, please explain:

Lift, Carry, Push, Pull Activity

Lift: Occasionally (1-33%) 11 - 20 lbs	Push: Frequently (34-66%) 10 lbs
Carry: Occasionally (1-33%) 11 - 20 lbs	Pull: Occasionally (1-33%) 11 - 20 lbs

If other Lift, Carry, Push, Pull, please explain:

Exposure

Animals (Category 1): NO	Moving Machinery: NO
Animals (Category 3): NO	Biohazardous Material: NO
Blood & Bloody Fluids: NO	Uncomfortable temperature/ humidity: NO
Radiation/ Radioactive: NO	Noise: NO
Chemical Hazards: NO	Working from Heights: NO
Electrical Hazards: NO	Confined Space: NO
3B or Class 4 Laser: NO	Dust and Dusty environments: NO
Hot Work: NO

If other exposure, please explain:

Use of Protective Equipment

Hearing Protection: NO	Eye Protection: NO
Half or Full Face Reusable Respirator: NO	Protective Clothing: NO

If other protection, please explain:

Use of Hands/ Wrists

Keyboard: YES	Pipefitting: NO
Fine Manipulation: YES	Grasping: YES
Repetitive Motion: YES

If other use of hands/ wrists, please explain:

Sensory

Ability to Speak: YES	Depth Perception: NO
Hearing: NO	Distant Vision: NO
Sight: YES	Near Vision: YES
Color Vision: NO	Peripheral Vision: NO

Emergency Conditions

During emergency conditions due to severe weather, natural disasters, major utility failures, or other unplanned events, certain personnel are activated to minimizethe impacts of emergencies and disasters, and to protect people, property, and restore the primary mission of the University of Nebraska Medical Center.These personnel occupy positions which are designated as 'Essential Positions.'

Essential: