IRB Administrator | Harvard University Administration
Harvard University Administration
Location
Cambridge, MA | United States
Job description
Job Summary
The IRB Administrator is part of a team that reviews and approves human subjects research protocols overseen by the Harvard University-Area (HUA) IRB. The IRB Administrator:
Collaborates with researchers, the IRB Chairperson and IRB members, and other University offices to ensure the protection of the rights and welfare of participants in the human research activities conducted by the University's faculty, scientists, and students. Assists researchers in adhering to IRB requirements, federal and state regulations, state law, University policies, and the ethical principles that apply to human research projects. Interacts closely with researchers from University-area schools including the Faculty of Arts and Sciences, Harvard Kennedy School of Government, Harvard Graduate School of Education, the Harvard Law School, Harvard Divinity School, Harvard Graduate School of Design, Harvard University Health Services, Radcliffe Institute for Advanced Study, Harvard School of Engineering and Applied Sciences, and Harvard Business School.
Primarily, the IRB Administrator independently approves human subjects research in their capacity as an Alternate Member of the HUA IRB. The IRB Administrator is identified by the IRB Chair as an experienced IRB reviewer who conducts activities on behalf of the IRB. This includes collaborating with researchers to determine the applicability of IRB oversight; interpreting regulatory requirements on a case-by-case basis; identifying flexibility in the regulations and policy to support novel research procedures; and synthesizing information from research protocols, grants and contracts, and regulations in the context of a given study. The IRB Administrator employs their professional and educational expertise in their independent decision making.
For those studies reviewed by the Convened HUA IRB, the IRB Administrator may be asked to contribute analytical, regulatory, and technical assistance during monthly IRB meetings. The IRB Administrator may serve as a voting alternate member if the primary member (faculty or community member) is not present.
This position will report to the IRB Assistant Director in the HUA IRB office.
Position Description
When conducting reviews of human subject's research as an Alternate Member of the HUA IRB:
- Correspond and meet with researchers, providing guidance on research development, and the applicability of human subject regulations and/or other laws and policies; strategize with researchers on how to conduct research in a manner that is both compliant with regulatory demands and meets research project expectations.
- Hold regular office hours for researchers and University administrators.
- Conduct scientific and scholarly review of research design as required.
- Determine whether research projects are exempt from further review.
- Review and approve non-exempt research projects as an Alternate Member of the HUA IRB.
- Analyze and review research protocols to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and Harvard University-Area IRB guidelines.
- Correspond with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered.
- Investigate and resolve issues of noncompliance.
When providing support to the Convened HUA IRB:
- Prepare documents for deliberation at IRB meetings, attend IRB meetings, compose meeting minutes, and communicate IRB determinations and actions to researchers.
- Correspond with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered.
Other responsibilities:
- Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development.
- Conduct monitoring of HUA IRB-approved human research projects.
- Develop training and educational activities on human research protections and present to researchers and administrators.
- Lead IRB staff meetings; select and conduct continuing education for IRB staff on regulatory and policy topics.
- Identify potential gaps in IRB policy and propose a revision to policy; serve on internal working groups to develop new or revised internal process, IRB policy, and/or research resources including IRB website development.
- Other duties as required.
Basic Qualifications
Candidates MUST meet the following basic qualifications in order to be considered for this role:
Bachelor's degree and 2 years of experience related to the field of human subjects research protections.
Additional Qualifications and Skills
Strong written and oral communication skills are essential, with demonstrated ability to organize, write about and discuss regulatory and complex issues clearly. The ability to communicate with a highly diverse group of people with sensitivity to cultural differences. Proven ability to take initiative and work both independently and as a team member, ability to manage multiple projects simultaneously, and work well under deadlines. Familiarity with electronic databases and automation systems is strongly preferred. An advanced degree in social or behavioral science, law, or public health is preferred. Experience working in a fast-paced academic research environment and with faculty from various academic disciplines is preferred.
Additional Information
There are 2 (two) available IRB Administrator positions.
Harvard University supports a hybrid workplace model which will actively support some remote work. Specific days and schedules for on-site work and remote work will be discussed during the interview process. Please note hybrid workers must reside in a state where Harvard is registered to do business (CA, CT, GA, IL, MA, MD, ME, NH, NJ, NY, RI, VA, VT, and WA).
The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up to date on CDC-recommended vaccines.
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