Job Information
Harvard University IRB Administrator in Cambridge, Massachusetts
66585BRAuto req ID:66585BRJob Code:405012 Admin Professional (N) Department Office Location:USA - MA - Cambridge Business Title:IRB AdministratorSub-Unit:Office of the President and Provost Salary Grade (https://hr.harvard.edu/salary-ranges#ranges) :056Time Status:Full-time Union:55 - Hvd Union Cler & Tech Workers Basic Qualifications:Candidates MUST meet the following basic qualifications 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: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 a demonstrated ability to organize, write about, and discuss regulatory and complex issues clearly. The ability to communicate with highly diverse groups 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 an academic research environment and with faculty from various academic disciplines is preferred.
Additional Information:This positon has a 3-month orientation and review period.
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. Department:Harvard University-Area (HUA) Institutional Review Board (IRB)Pre-Employment Screening:Education, IdentitySchedule:Full time. Monday through Friday, 35 hours per week. Job Function:General Administration Position Description:Principal Duties and Responsibilities (Essential Functions*):
When conducting reviews of human subjects research as an Alternate Member of the HUA IRB:
Correspond and meet with researchers, providing guidance on research development, the applicability of human subjects 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 meeting; select and conduct continuing education for IRB staff on regulatory and policy topics;
Identify potential gaps in IRB policy and propose 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.
School/Unit:University Administration EEO Statement: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, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.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, the 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.
Commitment to Equity, Diversity, Inclusion, and Belonging:Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.Benefits:We invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards) to learn more about our outstanding benefits package, which may include:
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.
Work Format:Hybrid (partially on-site, partially remote) LinkedIn Recruiter Tag (for internal use only):#LI-KP1Work Format Details:This is a hybrid position that is based in Massachusetts. Additional details will be discussed during the interview process. All remote work must be performed within one of the Harvard Registered Payroll States, which currently includes Massachusetts, Connecticut, Maine, New Hampshire, Rhode Island, Vermont, Georgia, Illinois, Maryland, New Jersey, New York, Virginia, Washington, and California (CA for exempt positions only). Certain visa types and funding sources may limit work location. Individuals must meet work location sponsorship requirements prior to employment.