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Director of Research Regulatory Compliance
The Office of the Vice Provost of Research (OVPR) provides the key services necessary to deliver exceptional results in research.
The Regulatory program in the Office of the Vice Provost for Research oversees the use of human subjects, animals, biohazardous materials, chemicals and radiation/laser use in research, teaching and training at Tufts University and supports the institutional committees that govern these areas. The proper use and housing of research animals is overseen by several different entities. Some are regulatory bodies that implement Federal or State law and others are groups that give accreditation to institutions that exemplify high standards of care for laboratory animals. The Social, Behavioral and Educational Research Institutional Review Board (IRB) assures, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research in these subject areas. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. It is the purview of the Institutional Animal Care and Use Committee (IACUC) to ensure that all activities that involve animals are in compliance with all these governing bodies and their mandates. Likewise, the proper use of biohazardous materials, chemicals and radiation/laser use is overseen by several entities including regulatory bodies that implement Federal or State or City laws. It is the purview of the Institutional Biosafety Committee (IBC), the Institutional Radiation & Laser Safety Committee (IRLSC) and the Institutional Chemical Safety Committee (ICSC) to ensure that all activities that involve biohazards, chemicals, and radiation/laser materials are in compliance with all these governing bodies and their mandates. Importantly, these regulatory and safety committees often work in close partnership with the safety programs charged with day-to-day oversight of animal care, use of biohazardouse materials, chemicals, radioactive materials and lasers.
What You'll Do
- Directs and oversees institutional compliance with federal regulations that govern a subset of human research and all animal and biohazardous research conducted at all four campuses of Tufts University and at Tufts Medical Center
- Ensures compliance with the following regulations and accreditation: Animal Welfare Act, Public Health Service Policy, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Guide for the Care and Use of Laboratory Animals, Association for the Assessment of Laboratory Animal Care, Int’l, Massachusetts Research Animal Regulations, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, as well as other local regulations
- Confirms the Institutions have the proper policies and processes to maintain compliance and good standing with regulatory agencies
- Assists with licensing of special-use laboratories, such as those performing BSL2 and BSL3 research, which requires responsiveness to Federal, State and Local (Boston, Grafton, Medford) policies and guidelines. This responsibility directly affects continued research funding and activities
- Directs the activities (SBER IRB, IACUC) or provides regulatory support (IBC, IRLSC, ICSC) for the regulatory committees that span all four campuses at Tufts University and at Tufts Medical Center
- Provides leadership of these regulatory charges at the Institution and establishes and executes the processes to achieve compliance
Oversight of SBER IRB and IACUC Administrative Staff
- Directs the daily operations of the SBER IRB and IACUC office
- Oversees the regulatory review processes, identifies efficiencies to increase faculty satisfaction with the regulatory processes, setts priorities, establishes practice and policy
- Provides leadership and development of the staff, such as hiring, training, mentoring and career development, establishing operational objectives and assignments, delegating assignments, overseeing coordination of work, and providing administrative supervision
The employee is expected to perform the following overarching activities to support high performance of the regulatory committees:
- Establishes metrics to measure operational effectiveness and efficiency of regulatory committees and drive strategic decisions
- Implements training and outreach, policy and procedure development, monitoring, quality review control, reporting and enforcement of research regulatory matters
- Assists in interpreting complex regulations, provides expert advice to the Senior Director/AVP and the Office of University Counsel and routinely recommends opportunities to improve and promote research regulatory efforts
- Special projects as assigned
Interaction with Other Institutional Offices
- Manages interactions with offices tangential to the SBER IRB/IACUC/IBC/IRLSC/ICSC regulatory committees
- Represent the Office of the Vice Provost for Research across campuses and between Tufts University and Tufts Medical Center to advance the research mission, serving as a key member on committees, task forces and councils as necessary
- Liaises with stakeholders such as Comparative Medical Services, Industrial Hygiene, Laboratory Animal Medicine Services, Occupational Health and Research Administration
- Works in close partnership with the Safety Programs charged with day-to-day oversight of animal care, use of biohazardous materials, chemicals, radioactive materials and lasers
- Identifies areas of risk, implements opportunities for partnership, and mediates solutions that will remove impediments to compliant research and increase efficiency
What We're Looking For
- Knowledge and skills typically acquired through completion of a Masters degree
- 8+ years in a biomedical regulatory position
- Minimum of 3 years of supervisory experience
- Knowledge of the federal regulations for human subject research and animal research
- Certified Professional IRB and/or IACUC Administrator
- Proficient use of the Microsoft Office suite of applications
- Proficiency in Wikis, electronic databases/document tracking, and management of websites
- Ability to communicate with all levels of faculty and staff within the institutions in an accurate, concise, helpful, and customer-service oriented manner
- Ability to follow the guidelines, policies, and procedures of the institutions and to facilitate compliance of others with these rules
- Knowledge of the federal and state regulations for recombinant and synthetic nucleic acid molecules and laboratory safety
Minimum $121,300.00, Midpoint $151,650.00, Maximum $182,000.00
Salary is based on related experience, expertise, and internal equity; generally, new hires can expect pay between the minimum and midpoint of the range.
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