Regulatory Specialist-IACUC

Position Summary

Provides administrative and organizational support to ensure the functioning of the IACUC. This role provides advice to faculty about Committee actions and actively communicates updated protocol information to the research community, Committee, and veterinary and administrative staff of Research Animal Resource Center (RARC).

Functions and services include support for WCM, WCM in Qatar, Hunter College personnel in the Belter Research Building, Burke Rehabilitation Center in Westchester, Hospital of Special Surgery (HSS) and Rockefeller University investigators using WCM facilities.

Job Responsibilities

• Reviews protocol submissions to ensure compliance with administrative requirements in advance of the IACUC meeting, including completeness of the protocol-including collaborations with other institutions.
• Processes administrative amendments submitted, i.e. personnel changes, as well as ensures these administrative requests are included in the review process by the Committee in accordance to government and institutional policies.
• Monitors the annual renewal compliance by generating the investigator listing, and providing support and communication to the investigator and associated designees to ensure appropriate and timely submissions.
• Assists with developing workflows and SOPs related to internal and external regulatory compliance activities. Serves as a resource regarding policies and procedures relating to institutional animal care and use, or related research compliance functions.
• Supports continuous improvements efforts by reccommending enhancements to management that would reduce operational turnaround times and increase efficiency.
• Participates in regular research meetings, prepares meeting materials as needed. Presents regulatory guidance materials during internal research meetings and study site trainings.
• Attends IACUC meetings; assigns protocols to reviewers, prepares agenda and minutes, assists in preparation of decision letters to investigators on outcome of animal research protocol request, as well as performs independent follow-up on action items.
• Interacts with other institutional offices, i.e. Grants & Contracts, Conflicts, etc., to provide pertinent information on animal subject projects (i.e. protocol status, approval date, etc.).
• Maintains knowledge of new and revised regulations pertaining to the use of animals in research.
• Responds to requests for information and provides assistance in solving a variety of problems. Provides clarification to the PI on any modifications requested during the Designated Member or Full Committee Review of the IACUC.
• Maintains various files and data stores for accurate historical records keeping and reporting, and updates tracking and search procedures when necessary.
• Initiates and drafts, maintains, updates and audits regulatory files. Completes required regulatory documentation. Prepares regulatory updates, materials, and presentations for meetings as requested.
• Creates and distributes status reports as needed for the research team. Maintains records on each study and data repositories to ensure regulatory compliance.
• Coordinates all aspects of the Committee’s functions and activities, including scheduling and logistics for meetings, inspections, and training sessions.
• Drafts regulatory training and guidance materials. Serves as a resource for U.S. and international collaborating sites. Ensures that external research collaborators have up to date study information, protocol amendments, templates, etc.

Education

Experience

Approximately 3 years of related work experience.

Experience working in a higher education setting preferred.

Experience in the area of animal care and use, institutional review, research administration, audit, or other area of research, compliance or oversight.

Knowledge of principles of ethics in animal research, IACUC regulatory requirement, the Animal Welfare Act and / or Guide for the Care and Use of Laboratory Animals.

Demonstrated experience developing and maintaining computerized databases and tracking systems.

Knowledge, Skills and Abilities

Licenses and Certifications

Working Conditions / Physical Demands

Salary : $47 - $54