Director, IRB Operations

Partners Healthcare System Somerville, MA
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 behaviors. 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.

Overview

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

Essential Functions:

1.Personnel Management

* 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

2.Conducts regular staff meetings; addresses staff conflict and individual performance issues. Operations

* 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

3.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

4.Non-compliance 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

5.External Agencies

* 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

6.AAHRPP Accreditation & Maintenance

* Oversees preparation and timely submission of Association for Accreditation of Human Research Protection Program (AAHRPP) accreditation application and annual reports

7.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

8.Activities across the Partners System

* Acts as IRB operations liaison with relevant offices at PHS and at the hospitals

9.Other

* 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

Skills Required

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

Working Conditions

office environment

Supervisory Responsibility

35 overall

Direct Reports TBD

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