Reporting to the Senior Director, Research Administration and Behavioral Research Services, and working closely with members of the research administration team, Harvard Business School (HBS) faculty, and administrative partners at HBS and across Harvard University (HU), the Assistant Director supports the research and scholarly activities of the HBS faculty by managing the administrative review process (IRB) for the use of human subjects in HBS research and ensuring the ethical principles that apply to human research projects are adhered to.
Human Subjects (IRB) Review
Analyzes and reviews all submissions by HBS faculty to ensure completeness and compliance with applicable federal regulations, State laws, Harvard, and HBS IRB policies. Identifies protocols that do not meet the regulatory criteria for human subject research. Determines whether research projects are exempt from further review; reviews and approves certain research projects as a designated reviewer; corresponds with researchers, articulating required modifications to study documentation, including consent forms, in order to secure approval, and requesting additional information needed before approval can be considered.
Is a subject matter expert on federal regulations, State laws, Harvard, and HBS IRB policies related to the protection of research participants. Provides guidance to individual researchers regarding IRB submissions, incomplete protocols, policy questions, and serves as a consultant on matters pertaining to the use of human subjects in HBS research. Serves as the point of contact on research related policies and procedures to HBS faculty, researchers and other administrators.
Serves as the liaison to Harvard University's Committee on the Use of Human Subjects (CUHS), attending staff meetings and ensuring policies and procedures are consistently applied at HBS.
Maintains active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development
Program Management and Delivery
Manages the entire submission review process of protocols by HBS faculty from beginning to end in the Harvard-wide electronic submission and tracking and reporting (ESTR) system. Reviews the ESTR queue, prioritizing submissions for review, ensuring goals relating to timely output, turnaround, accuracy, and customer service are met. Maintains up to date workflow documentation on all processes.
Provides guidance to researchers and administrators on the use of the Electronic Submission Tracking & Reporting (ESTR) system used to manage applications for review and automate correspondence.
Creates and maintains a system of monitoring relevant metrics to inform strategic decision making and policies around the use of human subjects in HBS research.
Develops, implements, and manages IRB education and training programs for faculty and staff promoting best practices, policies and procedures related to the use of human subjects in HBS research.
Responsible for other duties as assigned.
During the current period of COVID-19 related restrictions, this position may start as a remote position with the transition to onsite at HBS campus in Boston, MA when the office reopens.
While we continue to monitor the evolving COVID-19 guidelines and restrictions, we appreciate your understanding and flexibility with our interview process. Please note that we will be conducting interviews virtually (phone and or Zoom) for selected candidates until further notice.
Harvard will require COVID vaccination for all Harvard community members who will have any on-campus presence. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. More information regarding the University's COVID vaccination requirement and exceptions may be found at the University's
Bachelor's degree or equivalent experience required.
5-7 years of experience required, specifically in the area of conducting IRB reviews of social/behavioral research projects in a high-volume office where customer service is a priority.
Demonstrated knowledge of human subject protection and related regulations normally acquired through employment with an Institutional Review Board (IRB) required.
Current Certified IRB Professional (CIP) designation required. In the absence of such a designation, CIP eligibility must be obtained within 1 year of hire.
Experience using Huron Research Suite (Formerly Click) software or a similar IRB electronic-system software in the review of social / behavioral research protocols.
Excellent judgment and sound decision-making skills.
Experience in successfully managing projects from inception through completion (i.e., pre-review and designated review).
An understanding of and ability to manage highly confidential information.
The ability to communicate with a diverse group of people with sensitivity.
Demonstrated ability and comfort in teaching and presenting ethical and regulatory requirements in the protection of participants in research.
Demonstrated ability to work effectively in a complex organization and across multiple units and levels.
Ability to take initiative and work independently with an entrepreneurial spirit, flexibility, and high-capacity assess priorities and to meet competing deadlines.
A strong customer service orientation and excellent interpersonal skills.
EQUAL OPPORTUNITY EMPLOYER: We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Internal Number: 54408BR
About Harvard University Business School
Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world. The University has twelve degree-granting Schools in addition to the Radcliffe Institute for Advanced Study, offering a truly global education. Established in 1636, Harvard is the oldest institution of higher education in the United States.