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 provides independent review and oversight of Harvard Chan School research and other regulatory activities. It's overall purpose is to ensure the quality and integrity of research conducted at Harvard Chan School. This is accomplished through education and monitoring of research studies in order to ensure compliance with federal, state, and local regulations as well as institutional policies.
ORARC works in conjunction with various Harvard departments in areas such as conflicts of interest, data and information security, research integrity, intellectual property, animal research and biological safety. The office 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 Schools. The two primary units of the HLC HRPP include its Quality Improvement Program (QIP) and the HLC Institutional Review Board. The IRB Reliance Specialist, a new position for ORARC, will straddle responsibilities of both the QIP and IRB while serving as the lead on reliance-related inquiries and requests.
Additional duties and responsibilities include, but are not limited to, the following:
Works independently to lead and offer guidance regarding human subjects research applications submitted to the IRB where reliance is appropriate and/or anticipated
Provide front-line guidance to the Harvard Longwood Medical Area Schools faculty, staff, and students inquiring about the reliance process
Execute administrative review functions, including applicable ancillary reviews, as required, when a Harvard Longwood Medical Area School (HMS, HSDM, and Harvard Chan School) is engaged in human research and expected to rely on another institution for IRB review
Maintain a working knowledge of Harvard Longwood Campus IRB procedures, guidelines and policies for all research, and research subject to review under an IRB reliance agreement
Communicates cede determinations to HLC and external investigators for studies where HLC IRB is the reviewing IRB (sIRB) or a relying institution (participating site)
Serves as a HLC IRB liaison for external reliance platforms, including Smart IRB, where reliance determinations may be documented
Tracks reliance agreements when HLC IRB is the reviewing IRB or relying on an external IRB
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
Develop and participate in training and educational activities on human research protections that are presented to researchers and administrators
Develop and participate in QA/QI activities and initiatives designed to evaluate compliance of the HLC IRB reliance portfolio
Other duties as assigned
PLEASE NOTE: The finalist must obtain the Certified IRB Professional (CIP) designation or be CIP eligible at the time of hire. If the successful applicant does not already possess the CIP designation, they will be required to obtain it within 1 year of start date.
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!
Salary Grade: 056
Union: 00 - Non Union, Exempt or Temporary
Bachelor's degree or equivalent work experience required
3+ years experience required
Master's degree in related field preferred
Experience with an eIRB submission system or Smart IRB Online Reliance Platform preferred
Solid working knowledge of federal and state regulations governing human research and Good Clinical Practice guidelines preferred
Experience using multiple technical applications including Microsoft word processing, database management, spreadsheets, graphics and PowerPoint presentation software, electronic calendar, email, and other technical applications preferred
Strong analytical written and oral communication skills, and experience multi-tasking in a busy office environmental while maintaining superior customer service preferred
Experience maintaining strict standard of confidentiality preferred
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: 50607BR
About Harvard University T.H. Chan School of Public Health
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.