IRB Administrator View
The University of Kansas Medical Center - Wichita, KS

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This is an exempt, full-time 1.0 FTE unclassified appointment, subject to the regulations of the Kansas Board of Regents, University of Kansas and the State of Kansas.

The University of Kansas prohibits discrimination on the basis of race, color, ethnicity, religion, sex, national origin, age, ancestry, disability, status as a veteran, sexual orientation, marital status, parental status, gender identity, gender expression and genetic information in the University's programs and activities. The following person has been designated to handle inquiries regarding the non-discrimination policies: Director of the Office of Institutional Opportunity and Access, IOA@ku.edu, 1246 W. Campus Road, Room 153A, Lawrence, KS, 66045, (785)864-6414, 711 TTY.

Required Qualifications

Bachelors degree in a related field.

Experience applying and interpreting federal regulations, state and institution policies and procedures.

Demonstrated experience in giving guidance and alternatives to customers while maintaining compliance with regulations and policies.

Demonstrated high-level expertise in interacting and communicating (orally and in writing) with customers.

Demonstrated expertise in problem solving, attention to detail, and accuracy.

Evidence in work history of ability to handle multiple tasks, exercise independent judgment and meet deadlines.

Experience in previous positions of exercising and demonstrating commitment to continuous quality improvement.

Demonstrated experience and ability to work collaboratively in a team setting. Experience working with confidential information.

Ability to resolve problems in an accurate and timely manner.

Experience using Microsoft Office products Word, Excel and Access.

Preferred Qualifications

Master's degree in related field.

Familiarity with federal and state agency regulations regarding human subjects protection and confidentiality in research.

Significant experience participating in the research process ? e.g., as a research assistant or associate and/or experience with the Institutional Review Board (IRB) process.

Experience in managing/coordinating research compliance activities.

Experience working for a Kansas state agency and with state policies and procedures

Certified IRB Professional (CIP)

Teaching/training small to medium groups of individuals

Instructions for applying

Please complete an electronic application and click the "Apply for this Posting" button at the top of the page.

THE FOLLOWING FIELDS ARE USED FOR THE POSITION DESCRIPTION

Duty (1) Description

The IRB Administrator ensures that all KUSM-W human research protocols comply with federal and state laws for human research. The administrator supports the KUSM-W Human Subjects Committee 2 (HSC2) and the HSC chair to ensure timely and thorough review of all human research protocols. Key responsibilities include applying knowledge of federal, state, and local regulations and accreditation standards on human research to the review process; identifying all potential compliance areas that should be considered and advising the HSC2 and research personnel about regulatory requirements.

Duty (1) Essential or Marginal

Essential

Duty (2) Description

Maintain overall responsibility for managing review of all new and continuing human research protocols. Develop strategies to meet new regulatory and institutional requirements.

Develop and maintain a coordinated and efficient review process that incorporates all areas of research compliance

Conduct initial review all Human Subjects Committee 2 (HSC2; KUMC is HSC) submission forms to determine completeness and compliance with federal regulations, accreditation standards, university and HSC policies as well as HIPAA requirements.

Duty (2) Essential or Marginal

Essential

Duty (3) Description

Manage the reciprocity agreements

Conduct administrative review and categorize new research project submissions into appropriate category: exempt, expedited, full committee review or "not human subjects research"

Advise investigators on informed consent and protocol-specific regulatory requirements.

Design and implement special projects to enhance the efficiency of IRB.

Develop program strategies to meet new regulatory and institutional requirements.

Serve as a resource for investigators and HSC2 members regarding federal and state regulations and KUMC policies

Duty (3) Essential or Marginal

Essential

Duty (4) Description

Facilitate communication between investigators and the HSC2 committee; prepare and distribute correspondence to investigators, ensure committee decisions are timely and accurately communicated to investigators.

Manage proviso (condition for approval) process until final approval is obtained.

Record all HSC submissions and other actions, e.g., amendments, problem reports, continuing reviews, in the research compliance database. Ensure the database is current and accurate; recommend database modifications to improve efficiency and value of input/output.

Duty (4) Essential or Marginal

Essential

Duty (5) Description

Work closely with the HSC chair so that application materials are received, processed, disseminated and retained according to university requirements.

Maintain standard operating procedures (SOPs) to ensure quality control mechanisms

Manage the annual Conflict of Interest (COI) reporting and Human Subjects Training requirements for the Wichita campus. Ensure research personnel complete Human Subjects Training and Conflict of Interest disclosures.

Duty (5) Essential or Marginal

Essential

Duty (6) Description

Identify areas of noncompliance, analyze circumstances and ensure that remedial action is taken

Evaluate the effectiveness of HSC office procedures through routine self-audits

Coordinates the HSC meeting, processing of agenda items, and recording of accurate minutes Carryout all administrative actions taken during the meeting.

Duty (6) Essential or Marginal

Essential

Duty (7) Description

Actively participate in the mission of the department and team activities;

Offers assistance to team members as needed/requested;

Backup to Dean's Office Administrative Specialist for reception, answering phone calls for the Dean's Suite;

Backup for other department functions as assigned by supervisor;

Other duties/projects as assigned by supervisor.

Duty (7) Essential or Marginal

Duty (8) Description

Duty (8) Essential or Marginal

Duty (9) Description

Duty (9) Essential or Marginal

Duty (10) Description

Duty (10) Essential or Marginal

Marginal

Mental/Cognitive Requirements:
Communication

Comprehend and use basic language, either written or spoken, to communicate information and ideas

Yes

Comprehend and use technical or professional language, either written or spoken, to communicate complex ideas

Yes

Calculation

Perform numerical operations using basic counting, adding, subtracting, multiplying or dividing

Yes

Perform Complex quantitative calculations or reasoning using algebra, geometry, statistics, or abstract symbols

No

Problem Solving

Formulate and apply appropriate course of action for routine or familiar situations

Yes

Use logic to define problem, collect information, establish facts, draw valid conclusions, interpret information and deal with abstract variables for unique or unfamiliar situations

Yes

Other Mental/Cognitive Requirements (please describe)

Physical Activities

Repetitive Motion - Repeating movements of arms, hands, wrists

Occasionally (.5 to 2.5 hours/day)

Talk - Express or exchange ideas verbally

Constantly (5.5+ hours/day)

Hear - Perceive sound by ear

Constantly (5.5+ hours/day)

See - Obtain impressions through the eye

Constantly (5.5+ hours/day)

Level of physical activity

Light

Physical Requirements

Kneel- Bend legs at knee, come to rest on knees

Crouch/Squat - Bend body down and forward, bending legs and spine

Crawl - Move on hands, knees and feet

Climb - Ascend/descend ladders, stairs, ramps

Sit

Stand

Walk - Move about on foot

Average distance per shift

Stoop - Bend downward and forward at waist

Lift - Raise or lower 10 lbs. from one level to another

Lift - Raise or lower 25 lbs. from one level to another

Carry - Transport an object

Push - Press with steady force, thrust objects forward, downward, outward

Pull - Drag or tug objects

Turn/twist - Move a body part in circular motion

Bend - Bend downward and forward by bending the spine at waist

Balance - Exceeding ordinary body equilibrium

Reach - Extend hands and arms in any direction

Handle - Seize, hold, turn with hands

Ability to distinguish color

Other Physical Activity (please describe)

Average amount of time for other physical activity

The University of Kansas Medical Center - 22 months ago - save job