Virginia Tech is a public land-grant university, committed to teaching and learning, research, and outreach to the Commonwealth of Virginia, the nation, and the world. Building on its motto of Ut Prosim (that I may serve), Virginia Tech is dedicated to InclusiveVT—serving in the spirit of community, diversity, and excellence. We seek candidates who adopt and practice the Principles of Community, which are fundamental to our on-going efforts to increase access and inclusion, and to create a community that nurtures learning and growth for all of its members. Virginia Tech actively seeks a broad spectrum of candidates to join our community in preparing leaders for the world.
About the Division of Scholarly Integrity and Research Compliance
The Division of Scholarly Integrity and Research Compliance (SIRC) at Virginia Tech supports the business management of the Human Research Protection Program (HRPP). SIRC is deeply committed to both the highest ethical standards in scholarship, and to the proactive facilitation of basic, translational and transformative scientific research for the improvement of the human condition across the world. The office assists researchers with the fulfillment of their responsibility for compliance with policies and regulations pertaining to research. The SIRC is a critical unit within the Office of the Vice President for Research and Innovation (OVPRI) which supports university-wide strategic initiatives and operational functions of Virginia Tech’s $520+ million research enterprise and associated technology commercialization activities, which span nine academic colleges, eight university research institutes, and three affiliated corporations. The university is embarking on its next phase of strategic growth in research across its Blacksburg, Roanoke, and Northern Virginia locations, including the recent integration of the Virginia Tech Carilion medical school as Virginia Tech’s 9th college in 2018. Managing over 4500 IRB protocols a year, Virginia Tech’s HRPP team is committed to ensuring protection of the rights, dignity, and safety of all human subjects involved in teaching and research activities.
The HRPP Protocol Coordinator holds a key position in support of Virginia Tech’s ambitious plans to become a leading 21st century land grant university that delivers innovative solutions to the most pressing global challenges of our time. The HRPP Protocol Coordinator will be part of a dedicated team of HRPP professionals. The coordinator will provide oversight and management of research determinations, new protocols, and amendment submissions from Virginia Tech researchers and collaborators, and provide support for those protocols throughout the research lifecycle. As a liaison between the faculty and the office, the coordinator advises on regulatory and ethical compliance for IRB submissions and contributes to the division’s overall mission to protect the rights and welfare of human subjects involved in research. The HRPP Protocol Coordinator is responsible for, but not limited to: Creating an organizational culture within the team and across the research community that provides a safe, supportive, and enriching environment Serving as a liaison between the division, the IRB, and principal investigators to coordinate regulatory actions across the protocol lifecycle Providing excellent customer service to all staff, faculty, and IRB members for project-related inquiries and needs Serving as an expert on three or more topic areas critical to HRPP success as chosen or assigned, including: Regulations: Stay abreast of and responds appropriately to relevant regulations, laws, guidelines, ethical considerations, and common practices to be a reliable resources resource to the broader university community Policy, procedures, guidance: Assist the HRPP Director with policy, procedural, and guidance development; develop review checklists, write review guidance, manage layout and content of protocol management, create educational materials for website, reviewers, researchers, and board members Single IRB (sIRB): Support effective single-IRB, Smart-IRB, and Common Rule institutional policy and procedure development and implementation HIPAA: Serve as IRB liaison between HRPP coordinator team and the University’s HIPAA Compliance Office Data security: Stay abreast of data security best practices, including the use of apps in research, cloud based data storage, storage of sensitive and identifying information, and secure data enclaves Clinical trials: Manage VT’s clinicaltrials.gov entries to ensure compliance with the NIH/FDA clinical trial requirements FDA: Advise on regulatory requirements for the use of investigational devices and drugs in human subjects research Metrics and process improvement: Collect and analyze internal and external data for assessment and improvement of protocol reviewing and administrative functions Collaborations with external IRBs: Coordinate and review collaborative or multi-site research; prepare and review inter-institutional reliance agreements; coordinate with faculty and track submissions to external IRB Post approval monitoring: Conduct for-cause and random reviews; assist researchers with improvements that will ensure continued regulatory compliance and ethical treatment of human subjects Training, education, and outreach: Develop and deliver training modules for researchers on a variety of human subjects topics International research: Advise researchers on requirements for conducting research in other countries; manage the translation certification process for study documents (including for studies conducted with non-English speakers in the United States) Additional subject matter expertise as determined by the HRPP Director: For example, research with children, biomedical research, research with incarcerated populations, consent
•Bachelor’s degree in health/science or related field(s) or equivalent training or experience •Demonstrated progressive experience related to IRB issues and human subjects research protections •Demonstrated experience serving as a member of a research team conducting research or other experience working in an academic or medical center/school environment supporting IRB research activities •Demonstrated customer service experience •Strong analytical, time management and multi-tasking skills, communication skills, effective interpersonal skills •Ability to work independently, prioritize work, organize and manage a complex workload effectively under tight deadlines •Demonstrated ability to read and interpret complex documents such as research protocols, consent forms, federal regulations and guidelines, policies, and standard operating procedures (SOPs) •Must possess a learning orientation to changing technology •Experience in handling complex and confidential material
•Master’s degree or equivalent experience in social/behavioral or biomedical field •Certification as an IRB Professional (CIP) preferred at time of employment, required within two years of employment •Broad knowledge of research methods and terminology •Prior IRB experience with biomedical and/or behavioral research •Demonstrated prior expertise in one or more critical topic areas
Internal Number: SW0180688
About Virginia Tech
Nestled in the Blue Ridge mountains, Blacksburg VA is ranked as one of the Top 100 best places to live. It combines the bustle of an innovative University community with affordable housing and abundant natural beauty. Virginia Tech is ranked 25th in top public universities and in the top 10 in many of its engineering programs.