Job Description
Job Summary:
- 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.
- Regulatory interpretation, policy decisions, risk assessments, and final compliance determinations remain the responsibility of the Assistant Director, Research Compliance.
- This position explains requirements to PDs regarding documentation required to support compliance with applicable federal and non-federal research regulations and answers their routine questions.
- The progress of PDs and their timely payment is depending on their compliance, so this support is highly important for the PDs success.
- The Animal Compliance Specialist will serve as a resource for the PDs and performance sites on the unique compliance requirements of CARB-X.
- The incumbent will report to, and work closely with, the CARB-X Assistant Director, Research Compliance to identify and resolve compliance issues.
Responsibilities will include:
- Managing all information related to the compliance process including data and documentation to audit standards; propose changes to SOPs, templates, and guidance documents as necessary for review and approval by the CARB-X Assistant Director, Research Compliance; and proactively identifying and advancing opportunities to improve the process and tools.
- Escalates unusual, high-risk, or complex compliance issues to the CARB-X Assistant Director, Research Compliance for interpretation and resolution.
- The Animal Compliance Specialist performs assigned compliance activities in accordance with established CARB-X policies, SOPs, and regulatory guidance, referring Client, high-risk, or policy interpretation issues to the Assistant Director, Research Compliance.
Essential Function 1: Percent Time (%): 60%
- Coordinate and execute day-to-day animal research compliance activities for CARB-X PDs and Performance Sites (PSs).
- Review 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, NC3Rs, and client requirements, identifying issues requiring follow-up or escalation.
- Assist PDs and PSs in preparing and revising compliance documentation to meet established regulatory requirements and answering routine questions regarding CARB-X animal compliance requirements.
- Track the status of compliance submissions, approvals, action items, and required follow-up activities to support timely study initiation and continuation while proactively identifying opportunities to prevent project delays.
- Maintain complete, accurate, and audit-ready compliance records and supporting documentation, monitor expiration dates for protocols, licenses, assurances, and approvals, and notify appropriate stakeholders of upcoming actions.
- Identify routine compliance issues, research questions within established guidance, recommend solutions consistent with existing policies and procedures, and escalate Client, high-risk, or policy interpretation issues to the Assistant Director, Research Compliance.
Essential Function 2: Percent Time (%): 10%
- Prepare and coordinate Domestic and Foreign Assurance documentation, communicate with PSs regarding required information, and facilitate submission.
- Support OLAW administrative activities, including IIA activations/in activations and annual reporting.
Essential Function 3: Percent Time (%): 20%
- Partner with CARB-X Alliance Directors and Alliance Managers to communicate requirements to PDs.
- Serve as a resource to relevant PD on animal research compliance requirements.
- Assist the Alliance team in preparing compliance documentation ahead of Quarterly Meetings.
- Consult with CARB-X Assistant Director, Research Compliance and Alliance Lead on issues as needed.
Essential Function 4: Percent Time (%): 10%
- Proactively identify challenges to the timely and robust satisfaction of animal compliance requirements.
- Research issues related to foreign or domestic requirements, and with foreign or domestic performance sites and provide findings and recommendations for review by the Assistant Director, Research Compliance.
- Propose realistic options for resolution, engaging with client Central Offices and other stakeholders as assigned or directed.
- Stay abreast of regulatory changes, software tools and systems related to compliance to identify opportunities for improvement.
- Propose and draft revisions to SOPs, templates and guidance documents based on regulatory or process changes for review and approval by the Assistant Director Research Compliance.
- Ensure compliance and quality assurance.
Skills & Experience:
- 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.
Additional Skills:
- Analytical Skills: Intermediate.
- Clerical/Admin: Advanced.
- Computer/Technical: Intermediate.
- Oral Communication Skills: Intermediate.
- Project/Process Management: Advanced.
- Teaching: Not Applicable.
- Writing Skills: Intermediate.
- Work Experience: 3 – 5 years.