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Harvard University Admin Pro/Indiv Contrib in Cambridge, Massachusetts

52193BRAuto req ID:52193BRJob Code:358056 Admin Pro/Indiv Contrib Location:USA - MA - Boston Business Title:IRB Review SpecialistSub-Unit:------------ Salary Grade:056Time Status:Full-time Union:00 - Non Union, Exempt or Temporary Basic Qualifications:

  • Bachelor’s degree required or equivalent experience required

  • 3+ years directly related experience required

  • Demonstrated knowledge and understanding of federal regulations and guidance governing human research required

PLEASE NOTE: Shortlisted candidates will be required to conduct a (written) sample IRB application review to demonstrate regulatory and review knowledge.

PLEASE NOTE: The finalist for this position must have the Certified IRB Professional (CIP) designation or be CIP-eligible. If the successful applicant does not already possess the CIP designation, they will be required to obtain it within 1 year of start date -- and the CIP status must be maintained in good standing throughout employment as IRB Review Specialist. Additional Qualifications:

  • Master's degree in a related field preferred

  • Experience with an eIRB submission system preferred

  • Experience maintaining strict standards of confidentiality preferred

  • Strong analytical, written and oral communication skills, and experience multi-tasking in a busy office environment while maintaining superior customer service preferred

  • Experience using multiple technical applications including word processing, database management, spreadsheets, graphics and presentation software, electronic calendar, email, and other technical applications preferred

Additional Information:

  • Harvard University requires pre-employment reference checks and background screenings.

  • This position has a 90 day orientation and review period.

  • The Harvard T.H. Chan School of Public Health does not provide visa sponsorship for administrative and staff positions.


The Harvard T.H. Chan of Public Health is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – including fostering respect for all, serving the greater good, and welcoming individuals from diverse backgrounds, experiences, and perspectives. To learn more about the Chan School’s mission, objectives, and core values, please visit our website here.

Harvard offers an outstanding benefits package including:

  • Time Off: 3- 4 weeks paid vacation, paid holiday break, 12 paid sick days, 11.5 paid holidays, and 3 paid personal days per year.

  • Medical/Dental/Vision: We offer a variety of excellent medical plans, dental & vision plans, all coverage begins as of your start date.

  • Retirement: University-funded retirement plan with full vesting after 3 years of service.

  • Tuition Assistance Program: Competitive tuition assistance program, $40 per class at the Harvard Extension School and discounted options through participating Harvard grad schools.

  • Transportation: Harvard offers a 50% discounted MBTA pass as well as additional options to assist employees in their daily commute.

  • Wellness Options: Harvard offers programs and classes at little or no cost, including stress management, massages, nutrition, meditation and complimentary health services.

Harvard access to athletic facilities, libraries, campus events and many discounts throughout metro Boston.

Join the Harvard T.H. Chan School of Public Health to support our mission of health research and education, and to be a part of the oldest institution of higher learning in the country!Department:Office of Regulatory Affairs & Research CompliancePre-Employment Screening:Criminal, Education, IdentityJob Function:General Administration, ResearchJob-Specific Responsibilities:Duties and responsibilities include, but are not limited to, the following:

  • Serve as a member of the Harvard Chan School and Harvard University Faculty of Medicine IRB panels and participate, as prompted by department assignments and submissions, in convened IRB review of non-exempt human research (initials, continuing reviews, and modifications) and reportable new information, including adverse events and violation reports in accordance with federal, state, and local laws and regulations, School and University Policies and Procedures. When applicable, participate in agenda check in meetings prior to meeting preparation. When applicable, draft and submit submission-specific meeting minutes to the Associate Director of IRB Operations in a timely manner

  • Working independently, exercise the authority to make not-human-subjects research and/or exemption determinations; approve non-exempt minimal risk research using the expedited review procedure; approve minor changes in approved research not otherwise eligible for expedited review; review reportable new information; review financial conflict of interest reports, and prepare submissions for monthly convened IRB meetings

  • Serve as primary contact for assigned departments: provide accurate guidance, recommendations, best practices, and explanations to faculty, staff, and students in a timely manner

  • Review, assess, assign, and route incoming correspondence and IRB submissions in a timely manner; anticipate and resolve problems; keep ORARC leadership informed of project(s) status

  • Update and maintain ESTR system, internal tracking logs, and electronic filing system; draft, edit and prepare correspondence (including convened IRB review notification letters), reports and other material using word processing, spreadsheets and/or databases

  • Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development

  • Participate in ORARC educational activities and workshops, including IRB member education, QIP education series, and department-specific sessions, as needed

  • Other duties as assigned

PLEASE NOTE: Shortlisted candidates will be required to conduct a (written) sample IRB application review to demonstrate regulatory and review knowledge.

PLEASE NOTE: The finalist for this position must have the Certified IRB Professional (CIP) designation or be CIP-eligible. If the successful applicant does not already possess the CIP designation, they will be required to obtain it within 1 year of start date -- and the CIP status must be maintained in good standing throughout employment as IRB Review Specialist.

PLEASE NOTE: Until our return to campus and full operational status, which is still to-be-determined, this interview process and position will take place in a modified manner – including virtual interviews, remote onboarding, and remote work.

School/Unit:Harvard T.H. Chan School of Public Health 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 Office of Regulatory Affairs and Research Compliance (ORARC) ensures the quality and integrity of research conducted at the Harvard T.H. Chan School of Public Health. ORARC is responsible for a broad range of regulatory affairs and research compliance functions, which require coordinating with various Harvard departments in areas such as conflicts of interest, data and information security, research integrity, intellectual property, animal research and biological safety. ORARC also oversees efforts in international research compliance, which includes the review of institution collaboration agreements/MOUs, and providing global research ethics training.

ORARC provides administrative support for the Harvard Longwood Campus (HLC) Human Research Protection Program (HRPP), which acts as shared service across the Harvard Longwood Medical Area (LMA) Schools (Harvard Medical School, Harvard School of Dental Medicine, and Harvard T.H. Chan School of Public Health). The two primary units of the HLC HRPP include its Quality Improvement Program (QIP) and Institutional Review Board (IRB) Operations. The IRB Review Specialist is a critical member of the IRB Operations staff who is primarily responsible for performing designated review for assigned departments across the Harvard LMA Schools.

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