Assistant Director, Research Administration and Human Subjects Protection

The Assistant Director, has Research Administration and Human Subjects Protection primary responsibility to manage the HBS program for the protection of research participants ensuring compliance with all federal, state and local regulations, including HBS and Harvard University IRB policies and procedures.

Reporting to the Senior Director, Research Administration and Behavioral Research Services, and working closely with members of the research administration team, 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 HUA IRB policies. Identifies protocols that meet regulatory criteria for exemption from human subjects review. 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'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 submission review process of protocols by HBS faculty in the Harvard-wide electronic submission and tracking and reporting (ESTR) system. Reviews the ESTR queue, prioritizing and allocating 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.