GENERAL SUMMARY/ OVERVIEW STATEMENT:

The IACUC Regulatory Compliance Specialist has the overall responsibility for ensuring regulatory compliance within the areas of the animal care and use program that fall under the responsibility of the IACUC office. Leads the investigation, review and reporting of potential compliance concerns and adverse events. Manages the post-approval monitoring program to promote and assess compliance with approved IACUC protocols and institutional policies and standards. Oversees and coordinates the IACUC semiannual program review and facility inspection. Completes and submits all required Federal and State reports and acts as a liaison for all regulatory inspections. Develops and maintains IACUC protocol review processes and procedures that are consistent with applicable state and federal regulations and institutional policies. Serves as program manager for the AAALACi site visit and ensures the program meets the accreditation standards for IACUCs.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

* Investigate, review and report compliance concerns and reported events

o Receive all reported incidents and events; review for merit and conduct investigation with appropriate stakeholders; Prepare reports for review by the IACUC Compliance Subcommittee and final determination by the IACUC

o Record IACUC deliberations and determinations. Communicate results to appropriate parties

o Ensure corrective actions plans are implemented by research teams and other parties, alerting the Director and IACUC for support, as needed

o Identify and tabulate trends for IACUC review; identify, communicate and participate in opportunities for continuous improvement in IACUC processes and the animal care and use program

* Oversee all activities related to the PAM program including

o Schedule, coordinate and participate in, document, and ensure follow-up on all PAM activities

o Review annual reports, facility access requests and staff amendments

o Oversee and coordinate the IACUC semiannual program review and facility inspection. Schedule the inspection of all animal housing and use areas involving the committee members, consultants and the entire animal research community. Manage the semiannual program review. Document and present findings to the Committee. Prepare the report to the Institutional official. Ensure all findings and deficiencies have a corrective action plan and timeline for correction that is communicated to stakeholders in a timely manner. Document implementation of all corrective actions.

o Identify and tabulate trends for IACUC review; identify, communicate and participate in opportunities for continuous improvement in IACUC processes and the animal care and use program

* Complete and submit all required Federal and State reports and acts as a liaison for all regulatory inspections, including all reports to USDA APHIS, NIH OLAW, AAALACi, MDPH and the City of Cambridge.

* Assist investigators in understanding IACUC expectations for research using laboratory animals;

* Participate in the interpretation of animal welfare regulations to define IACUC policies, practices and procedures.

* Leads the investigation, review, and reporting

* Ensures all Federal and State reporting requirements are met, developing systems and procedures, and collecting the data necessary to ensure reports are accurate and timely.

* Monitor laboratory animal research activities to determine adherence to and compliance with institutional policies and applicable state and federal regulations by active participation in the following:

o Review of IACUC protocols, amendments, annual reports

o Prepare and submit semi-annual inspection and program evaluation reports to the IACUC and IO

o Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated

o Review and update of IACUC policies

o Program inspections (USDA, AAALAC, Cambridge commissioner, others)

o Preparation of annual reports and assurance letters to regulatory and accreditation agencies

o Other compliance monitoring including but not limited to: monthly census check, animals transfers, holding protocol, found dead animals (USDA species only), PAM Audits

* Develop forms and tools to enhance documentation of research activities and animal health monitoring to assure compliance with applicable USDA and PHS regulations, policies and guidelines including but not limited to:

o Tracking of facility inspections/audits/deficiencies/reportable events

o Continuous enhancement of the eIACUC application forms

o Defining the specifications for and maintenance of reports from Insight-Microstrategy

o Data update / data curation including: researcher's qualifications and experience; orientation/training attendance; OHS clearance; Other training (Cage side NHP training, CITI)

o Update and maintain IACUC internal website

* Identification and implementation of methods or tools for training and education of researchers and IACUC members

* Remain up-to-date on Federal and State regulations pertaining to laboratory animal care

* Other responsibilities as needed including:

o Serve as back-up for other office staff members

o Serve as IACUC representative on program-related meetings inside and outside the organization

o Participate in process improvement initiatives

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

o Extensive knowledge of animal welfare regulations and IACUC best practices

o Excellent oral and written communication skills

o Excellent organizational skills. Ability to manage to timelines and targets in administrative improvements. Capable of working independently.

o Excellent interpersonal skills. This position involves interacting with employees, customers, consultants and vendors at all levels of the organization and with very diverse backgrounds.

o Has a customer-focused attitude and enjoys working with similarly dedicated persons in a team fashion within a high-energy research environment.

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable):

CPIA preferred. Additional certifications such as ACLAM or AALAS or equivalent preferred

EDUCATION:

Bachelor's degree in related field required; Master's degree preferred.

EXPERIENCE:

5-10 years of experience required with a minimum of 3-5 years IACUC experience required.

WORKING CONDITIONS:

Standard office environment and onsite monitoring in animals holding areas and research laboratories. This is a hybrid position with a minimum expectation of 3 days on-site (preferably 4 days on-site) and 1 day remote.