Provides administrative support to the Harvard University-Area Institutional Review Board. Works with researchers, the IRB Chairperson and members, and other University offices to ensure 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. Investigates and resolves issues of noncompliance. Supports the IRB Chairperson and other IRB members by providing professional analytical and technical assistance while interacting 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.
He/she will report to the Senior IRB Administrator in the Harvard University-Area IRB office.
Principal Duties and Responsibilities (Essential Functions*):
Analyze and review applications for the IRB to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and Harvard University-Area IRB guidelines;
Determine whether research projects are exempt from further review, review and approve certain research projects on behalf of the IRB as a designated reviewer;
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;
Prepare documents for deliberation at IRB meetings, attend IRB meetings, prepare meeting minutes, and communicate IRB determinations and actions to researchers;
Develop and participate in training and educational activities on human research protections that are presented to researchers and administrators;
Provide guidance to researchers and administrators on the use of the Electronic Submission Tracking & Reporting (ESTR) system used by the Harvard University-Area IRB to manage applications for review and automate correspondence;
Conduct monitoring of Harvard University-Area approved human research projects;
Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development;
Other duties as required.
Salary Grade: 056
Union: 00 - Non Union, Exempt or Temporary
Candidates MUST meet the following basic qualifications in order to be considered for this role:
Bachelor's degree with at least 2 years of experience related to the field of human subjects research protections.
Demonstrated knowledge and understanding of the federal regulations on human research protections.
Demonstrated proficiency in the MS-Office Suite of computer applications.
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 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 database and automation systems 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.
* To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.
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: 46975BR
About Harvard University
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.