IRB Operations Manager - Office of the Vice Provost for Research - (20001662)
The Office of the Vice Provost for Research (OVPR) is responsible for pre-award administration of grants and contracts; supporting investigators in developing proposals and funding strategies for their research and scholarship; protection, management, and licensing of the University's intellectual property; oversight of the use animals, biological and chemical hazardous agents, human subjects, select agents, blood borne pathogens and radioactive materials and lasers in research, teaching and training; environmental health and safety; and implementation of the University's policies on conflict of interest in research, export controls, research integrity and research misconduct. The OVPR assures that the services and resources provided by the units under its direction meet the needs of the research community and satisfies the requirements of laws and regulations that govern research and protects the University's interests. This includes policy development, strategic planning and oversight. The OVPR also works closely with the research leadership of the schools and Tufts Medical Center to promote cooperation, collaboration, and sharing of resources to maintain a positive working relationship between the schools and with the hospital. Additionally, the OVPR maintains close working relationships with faculty and department chairs in order to keep abreast of the needs and direction of research and to foster an environment of open communication and responsiveness.
The Institutional Review Board (IRB) is a Federally-mandated committee that reviews all human subject research proposals to ensure that protocols are in place for the protection and welfare of human subjects of research conducted at or sponsored by the institution. The Social, Behavioral, and Educational Research (SBER) IRB oversees the social, behavioral, and educational research conducted by Tufts University investigators on all campuses and is responsible for the administration of the University's Human Subjects Protections Program.
Under minimal supervision and with extensive latitude for the use of initiative and independent judgment, the SBER IRB Operations Manager oversees the conduct of the SBER IRB Committee and directs the activities of the SBER IRB Office. S/he furnishes advice and guidance to the institutional official, members of the SBER IRB Committee, and other administrative offices responsible for aspects of human subjects research to ensure compliance with applicable federal, state, and local regulations, laws, policies, and procedures. S/he facilitates the IRB approval process via expert support of faculty, students, and staff conducting research, oversight of IRB committee management, and management of protocol review operations. S/he reviews and negotiates terms of IRB reliance agreements for oversight of collaborative and multi-institution research, and is authorized to approve and sign agreements on behalf of Tufts University. S/he also oversees post-approval protocol monitoring, including the conduct of for-cause and not-for-cause audits, and reports non-compliance and unanticipated problems as required to applicable federal agencies. S/he serves as the institutional This position manages staff and provides training and mentorship to IRB analysts and IRB committee members. Duties also include proactive outreach to faculty, facilitating multidisciplinary collaborations between all three Tufts campuses, and harmonization of policies and procedures with the Tufts Health Sciences IRB when possible. The decisions of the SBER IRB Operations Manager have a direct impact on the University, as this position carries out the University's obligations under our federal-wide assurance with the U.S. Department of Health and Human Services, and influences University risk and compliance.
3-5 years of related experience required.
Master's Degree or commensurate experience required.
Microsoft Office - word, excel, power point; internet; ability to learn electronic protocol management systems.
Substantial human subjects research oversight experience, and expertise in the human subject protection review and approval process.
Familiarity with HHS and FDA Federal Regulations pertaining to human subject research (45 CFR 46) and (21 CFR 50 and 21 CFR 56).
Excellent organizational and administrative skills.
Excellent verbal and written communication skills.
Ability to engage with all levels of faculty, students, and staff in an accurate, concise, and customer-service oriented manner.
Teaching experience or excellent public speaking skills.
Ability to adapt to a changing work environment.
Capable of functioning independently with minimal supervision.
CIP (Certified IRB Professional).
Experience with oversight of social, behavioral, educational, and anthropological research.
Familiarity with SMARTIRB online reliance system.
Familiarity with DoD Directive 3216.02.
Familiarity with Huron IRB software solution protocol management system.
Special Work Schedule Requirements: There may be a need to work additional hours during times when there is an unexpectedly high volume of protocol submissions or when there is a specific project that needs completion.
An employee in this position must complete all appropriate background checks at the time of hire, promotion, or transfer.
Primary Location: United States-Massachusetts-Boston
Organization: Office of the Vice Provost
Employee Status: Regular Schedule: Full-time
Job Posting: Nov 13, 2020, 3:36:54 PM
Internal Number: 20001662
About Tufts University
Tufts is a leader in American higher education, distinctive for its success as a moderately sized university that excels at research and providing students with a personal experience. Our unique combination of research and liberal arts attracts students, faculty and staff who thrive in our environment of curiosity, creativity and engagement.