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 (SPH). The ORARC provides independent review and oversight of SPH research and other regulatory activities. It's overall purpose is to ensure the quality and integrity of research conducted at the Harvard T.H. Chan School of Public Health. 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 Human Research Protection Program (HRPP), which acts as shared service across the Harvard Longwood Medical Area Schools. The Quality Improvement Program (QIP) is one of the major components of the Harvard Longwood Campus HRPP. QIP works independently, but complementary to the Harvard Longwood Campus IRB to facilitate the IRB review and approval process. QIP consists of three distinct units: Compliance, Education, and Human Research Support.
The QA/QI Specialist responds to assigned research support service requests, including staff personnel support, IRB submission assistance, study start-up consultation, on-site monitoring, and external audit preparation. They also use independent judgment to identify areas for improvement and recommend best practices to customers for implementation at study site(s), act on behalf of the Quality Improvement Program to provide research community with technical regulatory expertise, and adhere to federal regulations, ethical guidance, University policy, and the Harvard Longwood Campus Human Research Protection Program toolkit.
Additional duties and responsibilities include, but are not limited to, the following:
Provide front-line support and information for customers of the Quality Improvement Program, including HLC faculty, students, and staff regarding its services and tools
Develop and deliver educational curriculum for the HLC research community by request and when initiated by ORARC (both domestically and abroad), including managing the QIP Ed Series and other QIP-initiated educational/training offerings
Conduct on-site reviews (both domestically and abroad) to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process; report confidential, and often sensitive, on-site reviews/audit findings to Investigators; recommend corrective actions
Serve as the primary Protocol Registration and Results System (PRS) Administrator for the Harvard LMA Schools clinicaltrials.gov accounts (e.g. - providing new user accounts; addressing (or refer to clinicaltrials.gov admin) user inquiries; implementing regular monitoring to reconcile address deficiencies and reconcile problem records, etc.)
Draft, edit and prepare correspondence, reports, study management tools, and other material using word processing, spreadsheets and/or databases
Contribute to office goals by accomplishing other related duties as required and assigned by ORARC leadership (e.g. - accreditation activities, participant outreach activities, sIRB support, etc.)
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
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
Experience with an eIRB submission system preferred
Direct experience drafting grant applications/proposals for a variety of funders, including federal government, industry, and/or private foundations 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 a 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: 50243BR
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.