Manager, Iacuc Compliance And Education

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The MGH Office of Animal Welfare Assurance is a group of highly motivated individuals who work collaboratively to support and promote pre-clinical research at one of the leading research institutes in the country. Our office supports the IACUC who oversees the MGH animal care and use program. The IACUC acknowledges the essential role that animal research plays in making discoveries that turn into treatments, diagnostics, and devices that improve quality of life.

The Manager is accountable for operations within the Office of Animal Welfare Assurance, and will develop and implement system-wide policies, processes and procedures to ensure full compliance of the office with Federal, State, and local regulations for the conduct of animal research. The incumbent is responsible for the knowledge and application of current animal research regulatory requirements, quality assurance/improvement, and grant-funded research activities, making independent decisions regarding regulatory interpretation, predominately as it applies to protocol review activities. Will be responsible for the Institutional Animal Care and Use Committee, ensuring the IACUC is fully constituted and operates within regulatory standards and research norms. Will also be the point-of-contact for external collaborations and relations with industry, ensuring MGH standards for excellence in animal welfare are maintained during collaborative research and contracted work, and will be responsible for regulatory reporting to the oversight agencies. Will work collaboratively with stakeholders and subject matter experts to develop high-quality training materials directed internally and externally.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Key Responsibilities, including but not limited to:

• Manage personnel matters, including all hiring, firing, compensation, and evaluation decisions for the protocol review team. Implement all institutional policies related to all phases of personnel activity, including recruitment, interviewing, compensation, benefits, orientation, performance evaluations, promotions, transfers, and terminations. Ensure appropriate training of employees. Assess employee workload and implement changes as needed.

• Manage the IACUC Board, ensuring membership meets regulatory requirements and that MGH research departments are appropriately represented, recruiting new or additional members when needed. Identify and respond to member concerns and any issues about members activities, including absences, delayed reviews or reviews not meeting ethical or local policies and standards. Maintain POI status for community representatives and ensures payments of all stipends. Develop and implement training and education program for all new members, and an effective continuous education program for the current membership, as required by the regulations.

• Oversee all aspects related to meetings including adherence of agendas, minutes, voting and other requirements to regulatory standards. Point of contact for protocol review team for member assignments, level of review, timing of review and other issues. Point of contact for investigators with funding or other circumstances needing attention.

• Accountable for protocol review policies and procedures including ensuring implementation of FCR, DMR and VVC review in accordance with regulation, making continuous improvements to maximize flexibility in the regulations and reducing administrative burden to the Investigator, the IACUC, and the OAWA. Represent protocol review in accreditation documentation, regulatory reports and during regulatory inspections. Identify, implement, and communicate changes to policy and practice in response to changing regulation or institutional decisions.

• Using available metrics, monitor consistency in review between protocol review team members, and IACUC members, implementing strategies to modify standards and practices as needed through education, training, and/or corrective action.

• Oversee the grant congruency review process, including meeting JIT requirements. Establish and maintain standards and best practices consistent with NIH and other expectations.

• Maintain the protocol form set, collaborating with the protocol review and compliance teams, prereview team, CCM, ancillary committees and other stakeholders to modify and update the form set as needed; working with the Business Analyst for the MGB governance process.

• Develop, in collaboration with stakeholders as appropriate, creative pro-active education and support materials for development and implementation of animal research protocols as requested by the IACUC Executive Committee and/or IACUC, as requested or as needed by Investigators, and at the recommendation of regulators and auditors, or in response to deficiencies they identify.

• Manage industry collaboration and the subcontracting process as it relates to IACUC regulation. Point of contact in collaboration with CCM Veterinary team member to meet all industry sponsor documentation or other needs, including preparing for site visits or other industry requirements, alerting the Director for any non-standard requirements. Manage the MOU requirements for IACUCs conducting collaborative research including accurate application of standard agreements or escalating to the Director and/or OGC to negotiate specific terms.

• Lead and oversee process improvement initiatives within the department.

• Represent the team on local/national regulatory work groups and committees as appropriate.

• Remain current on federal, state, and local laws governing animal research including attendance at conferences, workshops, seminars, or lectures.

• Contribute to the overall management, service levels and operational improvement of the department.

• Serve as a resource and role model for team members. May perform the work of team members as needed to address staffing needs, coverage and variations in work. May provide coverage for director during prolonged absence.

• Participate in and/or lead meetings, committees, projects and other ad hoc responsibilities.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Expert understanding of animal care and use within a research setting as well as regulations governing same. Engages in ongoing professional development and maintains up-to-date knowledge of affiliated topics.

• High level ability to effectively manage operations to meet the needs of the department, researchers and research enterprise. Able to identify workflow, process and other routine needs to support management and progress of the work and team. Coordinate, oversee and develop the work of others.

• Highly developed and demonstrated leadership skills to develop and manage across a range of program needs and collaborations. Able to effectively plan, influence and improve operations.

• Able to effectively document, communicate and train on regulations, policies and practices across a diverse population. Hold effective meetings with appropriate and timely follow-up.

• Advanced knowledge of scientific terminology and routine research practices.

• Advanced analytical, organizational and problem-solving skills along with the ability to work in a timely manner, meet deadlines and accommodate ad hoc responsibilities and to hold others accountable for same. Proactively monitor, identify and resolve operational matters.

• Effective communication skills both oral and written with the ability to communicate complex information in an understandable manner. Professional representative of the department through all transactions, meetings, presentations and other engagement. Strong platform skills in presenting meetings, speaking engagements and trainings. Effective in providing feedback and performance management.

• Engage in, support and promote a highly engaged and effective team. Work independently and with professionalism, collaboration and high level of engagement.

• Able to build, maintain and manage relationships with all personnel internal and external to the organization. Can implement ad hoc workgroups and teams as well as use project management skills.

• Lead and adapt to new processes, policies and protocols, ensuring work is completed to current standards. Apply and communicate new information to support the knowledge base of others.

• Financial skills to appropriately manage department expenses and budget along with a strong understanding of grants management.

• Accurate recordkeeping and data management as well as computer use (Microsoft and databases). Maintain confidential information at the highest level.

QUALIFICATIONS:

• Bachelor's degree in a related field.

• Required: A minimum of 5-7 years of experience in a research setting, with a minimum of 3 years of experience in an IACUC office or animal research setting.

• Required: A minimum of 3 - 5 years of direct management experience of an animal research compliance program required.

• Demonstrated working knowledge of federal, state, and local laws and regulations governing animal research.

LICENSES, CERTIFICATIONS and/or REGISTRATIONS:

• Current certification as an IACUC professional (CPIA) desirable.

SUPERVISORY RESPONSIBILITY:

• Direct management of 3 review specialists as well as applicable administrative staff and others as needed. Provide indirect leadership to committees and workgroups.

FISCAL RESPONSIBILITY:

• Prudent use of hospital resources. Cost-effective management of personnel expenditures, office budget, grant funds and other financial areas of responsibility.

WORKING CONDITIONS:

• Standard office environment. This is a hybrid position with a minimum expectation of 1 day on-site and 4 days remote.

• Work hours may vary due to needs of role, including meetings.