IACUC/IBC Regulatory Compliance Specialist

Department

BSD ARC - IACUC / IBC

About the Department

The mission of the Animal Resources Center (ARC) is to assist investigators in performing their animal research while ensuring appropriate and humane care of all laboratory animals.

The Animal Resources Center (ARC) at The University of Chicago is responsible for the use and care of all research animals on campus.

The ARC manages 6 facilities and a business office. Its sections are as follows : husbandry, maintenance, operations, veterinary care, finance and administration.

The unit merged with the Office of Shared Research Facilities managing all of the BSD cores on campus.

Job Summary

Provides administrative and compliance support to the Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC).

The IACUC is the faculty committee responsible for reviewing all research and teaching involving live vertebrate animals.

The IBC is the faculty committee responsible for reviewing all research involving DNA, infectious agents, or bio-hazardous materials.

Receives IACUC and IBC protocol submissions from investigators, pre-reviews the protocols to ensure the quality and completeness of the submission, and routes protocols through the proper regulatory review processes until a final resolution has been determined by the respective Committees.

Provides assistance to investigators and research staff in the preparation and submission of research protocols.

Responsibilities

• Receives IACUC and IBC / SA-IBC protocol submissions, performing administrative review of protocols to ensure completeness of submission, verification of completion of training requirements, verification of congruence with related grants.
• Reviews investigator responses to all correspondence to ensure completeness of answers prior to forwarding of responses to reviewer.

Provides assistance to investigators in the preparation of their protocols and prepares letters to the investigators generated as a result of the review process.

If IACUC protocol involves bio-hazardous agents, ensures that an IBC protocol is completed appropriately. Ensures supplemental forms are submitted for review to the appropriate offices (e.

g., Office of Chemical Safety, Office of Radiation Safety). If IBC / SA-IBC protocol involves animals, ensures IACUC protocol is completed appropriately.

Prepares and delivers all IACUC correspondence including all preliminary review, pending conditions, follow-up pending conditions and deferral letters.

Prepares IACUC and IBC / SA-IBC meeting agendas, organizes meeting packets, and drafts minutes of monthly meetings

• Prepares and conducts IACUC Semi-Annual Facility Inspections. Follows-up with principal investigators regarding resolution of deficiencies.
• Drafts and finalizes PDF forms used for all IACUC submissions including the main protocol form and all supplemental forms using appropriate software (LiveCycle).
• Works with University Research Administration (URA) on grants and contracts related to laboratory research that require memorandums of understanding (MOU) and material transfer agreements (MTA).
• Assists with Post-Approval Monitoring (PAM) including record reviews and procedural observations. Communicates with PIs on issues and provide follow-up.
• Performs beta testing for AIMS Business Objects and AURA-IBC.
• Maintains AIMS template dictionary and email distribution list for principal investigators and their primary lab contacts.
• Plans and executes internal and external audits and activities to support regulatory agency inspections.
• Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
• Performs other related work as needed.

Minimum Qualifications

Education :

Minimum requirements include a college or university degree in related field.

Work Experience :

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications :

Preferred Qualifications

Education :

Bachelor's degreeor advanced degree in a field pertinent to work being conducted.

Experience :

3-5 years previous animal research experience and / or animal care environment / setting.

Technical Skills or Knowledge :

Proficiency in Microsoft Word, Excel and Adobe.

Preferred Competencies

• Good organizational skills.
• Prioritize and efficiently deal with a multitude of tasks.
• Communicate effectively, verbally and in writing, and diplomatically with other administrators and investigators.
• Interpret research protocol information in relation to federal guidelines and internal policies.

Working Conditions

• Comfortable with being at one's desk for most of the day.
• Use of standard office equipment.
• Walking around campus on occasion.

Application Documents

• Resume / CV (required)
• Cover Letter (preferred)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Legal & Regulatory Affairs

Role Impact

Individual Contributor

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

Benefits Eligible

Drug Test Required

Health Screen Required

Motor Vehicle Record Inquiry Required

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