PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The Director of IRB Operations leads and manages the day-to-day operations of the Human Research Office (HRO) within Human Research Affairs (HRA) ensuring that the office effectively and efficiently operates in compliance with applicable state and federal regulations and institutional policies and procedures. The Director of IRB Operations reports to the Director, Human Research Affairs.
Principal Duties and Responsibilities
Provides leadership, guidance, and management on all aspects of day-to-day IRB operations; establishes and maintains culture of excellence, inclusion, and superior customer service; provides guidance on best practices and management of direct reports
Hires, manages, and develops management staff and other staff supporting IRB operations; oversees training of new HRO staff; develops a high trust, high performance work team
Monitors staff workloads and redistributes as needed
Prepares and oversees HRA budget, organizational structure and function of HRO
Guides and facilitates IRB management system updates, including business requirements and user acceptance testing
Oversees business processes for ceding IRB review to external IRBs
Guides and facilitates the transition of new Partners entities to the Partners IRB system
Participates with HRA Directors and research leadership in strategic planning; implements strategic plan at the direction of the Director; works to meet strategic goals and targets
Human Subject Research Review and Oversight
Interprets relevant state and federal regulations; develops and/or revises institutional policies and procedures, as needed, to assure compliance with applicable laws and regulations
Provides guidance to staff on complex regulatory issues
Provides guidance and input on reports to regulatory agencies of noncompliance, suspension or termination of research, or unanticipated problems involving subjects or others
Reports non-compliance issues to the Institutional Officials, Senior Vice President for Research, or Chief Academic Officer as needed or as directed
Communicates as needed with federal and state regulatory agencies, such as the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP), and the Massachusetts Department of Public Health on matters relating to human subject protections
Coordinates, as needed, and participates in regulatory agency site visits and audits; analyzes and assesses audit findings and proposes and implements changes to IRB policies and procedures to address findings, when needed
Drafts correspondence on behalf of HRA to external agencies as needed or as directed
AAHRPP Accreditation & Maintenance
Oversees preparation and timely submission of Association for Accreditation of Human Research Protection Program (AAHRPP) accreditation application and annual reports
Metrics and Reporting
Develops and analyzes key operational and performance metrics to measure progress against goals and targets and identifies opportunities for improvement; aligns metrics to industry best practices and keeps review timelines consistent with national metrics; distributes reports to senior leadership on a regular basis and upon request
Integrates performance metrics into performance reviews
Activities across the Partners System
Acts as IRB operations liaison with relevant offices at PHS and at the hospitals
Conducts other activities/projects at the direction of the HRA Director.
Minimum of a Masters degree in related field required
Working knowledge of state and federal regulations that pertain to human subjects research
Minimum of 10 years human subjects research oversight experience
Minimum of 5 years of management experience with budget responsibility
Experience working in an academic medical center IRB office strongly desired
Excellent communication skills – both oral and written; ability to clearly and effectively communicate to individuals at all levels, including junior research staff, senior researchers (senior faculty members, research leadership), IRB members
Demonstrated leadership and mentoring skills to effectively manage and develop staff members
Excellent analytical skills and critical thinking
Excellent organizational skills, ability to pay close attention to detail
Ability to treat confidential information with utmost discretion
Ability to multi-task and prioritize in a fast-paced environment
Ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives
Ability to work with IRB management systems
Internal Number: 3064775
About Partners HealthCare
As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Partners HealthCare supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.
We’re focused on a people-first culture for our system’s patients and our professional family. That’s why we provide our employees with more ways to achieve their potential. Partners HealthCare is committed to aligning our employees’ personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development—and we recognize success at every step.
Our employees use the Partners HealthCare values to govern decisions, actions and beha...viors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.