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 & QA/QI 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.
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
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 overarching mission of the Harvard School of Public Health is to advance the public’s health through learning, discovery, and communication.
To pursue this mission, the School produces knowledge through research, reproduces knowledge through higher education, and translates knowledge into evidence that can be communicated to the public, policy makers, and practitioners to advance the health of populations.
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