Remote Animal Compliance Specialist

The Compliance Director is a member of the Operations Team and leads the compliance team at CARB-X. The CARB-X Animal Compliance Specialist assists with the animal compliance process for all CARB-X Product Developers (PDs) engaged in these studies. The Animal Compliance Specialist is responsible for operational execution and coordination of animal compliance activities.

Responsibilities

• Managing all information related to the compliance process including data and documentation to audit standards.
• Proposing changes to SOPs, templates, and guidance documents as necessary for review and approval by the CARB-X Assistant Director, Research Compliance.
• Proactively identifying and advancing opportunities to improve the process and tools.
• Escalating unusual, high-risk, or complex compliance issues to the CARB-X Assistant Director, Research Compliance for interpretation and resolution.
• Performing assigned compliance activities in accordance with established CARB-X policies, SOPs, and regulatory guidance.
• Coordinating and executing day-to-day animal research compliance activities for CARB-X PDs and Performance Sites (PSs).
• Reviewing Vertebrate Animal Section (VAS) documents, congruency statements, IACUC (or equivalent) approval letters, and other required compliance documentation for completeness and conformance with CARB-X, OLAW, NC3
  
  Rs, and
  *** requirements.
• Assisting PDs and PSs in preparing and revising compliance documentation to meet established regulatory requirements.
• Tracking the status of compliance submissions, approvals, action items, and required follow-up activities.
• Maintaining complete, accurate, and audit-ready compliance records and supporting documentation.
• Identifying routine compliance issues, research questions within established guidance, recommending solutions consistent with existing policies and procedures.
• Preparing and coordinating Domestic and Foreign Assurance documentation.
• Partnering with CARB-X Alliance Directors and Alliance Managers to communicate requirements to PDs.
• Proactively identifying challenges to the timely and robust satisfaction of animal compliance requirements.
• Staying abreast of regulatory changes, software tools and systems related to compliance to identify opportunities for improvement.

Qualifications

Working knowledge of and interest in animal research regulations. Strong organizational skills with high attention to detail. Experience reviewing IACUC protocols or animal use documentation. Familiarity with OLAW Assurances and AAALAC-accredited programs. Experience working with CROs, academic research organizations, or federally funded research. Familiarity with international animal research compliance requirements. Excellent written and verbal communication skills. Ability to work independently in a remote, fast-paced, and collaborative environment.

Required Skills

• Strong organizational skills with high attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently in a remote, fast-paced, and collaborative environment.

Preferred Skills

• Experience reviewing IACUC protocols or animal use documentation.
• Familiarity with OLAW Assurances and AAALAC-accredited programs.
• Experience working with CROs, academic research organizations, or federally funded research.
• Familiarity with international animal research compliance requirements.