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 Research and Innovation which supports university-wide strategic initiatives and operational functions of Virginia Tech's $590+ 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 3500 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 researchers 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:
o 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
o 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
o Single IRB (sIRB): Support effective singleIRB, SmartIRB, and Common Rule institutional policy and procedure development and implementation
o 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
o Clinical trials: Manage VT's clinicaltrials.gov entries to ensure compliance with the NIH/FDA clinical trial requirements
o FDA: Advise on regulatory requirements for the use of investigational devices and drugs in human subjects research
o Metrics and process improvement: Collect and analyze internal and external data for assessment and improvement of protocol reviewing and administrative functions
o Collaborations with external IRBs: Coordinate and review collaborative or multisite research; prepare and review interinstitutional reliance agreements; coordinate with faculty and track submissions to external IRB
o Training, education, and outreach: Develop and deliver training modules for researchers on a variety of human subjects topics
o 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)
o Additional subject matter expertise as determined by the HRPP Director: For example, research with children, biomedical research, research with incarcerated populations, consent.
