Job Title: CARB-X Animal Compliance Specialist
Job Location: Boston, MA (Can be remote – Must be local to Boston, MA)
Job Duration: 3 months (Possibility of temp to perm)
Pay: $30.00/hr on w2
Job Details:
Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is the largest externally-funded program at *** reporting to the Vice President and Provost for Research. CARB-X is a global non-profit partnership dedicated to accelerating antibacterial research and development to tackle the threat of drug-resistant bacteria. The CARB-X portfolio is the world’s most promising early development pipeline of innovative products to prevent, diagnose and treat life-threatening bacterial infections. CARB-X is grant-funded and currently supported by multiple government and foundation funders. The CARB-X environment is innovative, dynamic, energetic, and rapidly evolving. 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. 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%
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 *** 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%
Description: Prepare and coordinate Domestic and Foreign Assurance documentation, communicate with PSs regarding required information, and facilitate submission. Support OLAW administrative activities, including IIA activations/inactivations and annual reporting.
Essential Function 3:
Percent Time (%): 20%
Description: 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%
Description: 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.
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
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.