IRB Administrator

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.

• 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.

• 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.

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.

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.

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.

• Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers.
• Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date.
• Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
• Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service.
• Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.
• Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions.
• Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.
• Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more.
• Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.