Our client, a Boston-based University, needs a temporary (3+ months) CARB-X Animal Compliance Specialist who 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 may be a remote full-time position, although only local candidates in the area will be considered.
The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) program is the largest externally funded program at the University, and is a global non-profit partnership dedicated to accelerating antibacterial research and development to tackle the threat of drug-resistant bacteria.
The Animal Compliance Specialist 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 novel, high-risk, or policy interpretation issues to the Assistant Director, Research Compliance.
Other tasks include, but are not limited to:
Description: 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 University 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 novel, high-risk, or policy interpretation issues to the Assistant Director, Research Compliance.
Requirements and Skills
- Analytical Skills: Intermediate
- Clerical/Admin: Advanced
- Computer/Technical: Intermediate
- Oral Communication Skills: Intermediate
- Project/Process Management: Advanced
- Writing Skills: Intermediate
Work Experience: 3 – 5 years
- 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