Sr Human Subject Research Spec

University of Rochester-posted 12 days ago
Full-time • Mid Level
Rochester, NY
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As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. GENERAL PURPOSE: Manages and oversees the activities that establish, monitor and maintain human subject research, including responsibility for ensuring proper staff training. Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas. Manages, designs, implements and evaluates study changes. May supervise others up to two employees. This position is lead prevention interventionist and project manager for multiple grants testing evidence-based programs (EVPs) that strengthen natural social networks in community settings. Preventing suicide, depression and substance use are focus areas of these EVPs. The position entails engaging community members and sites, coordinating and leading program implementation, and human subjects research to evaluate impact of these programs. Duties include recruiting sites, training of program implementers and supervising and monitoring program fidelity, independently implementing EVPs, liaising with site leadership, and interacting with research participants. May provide training on federal, state, sponsor and/or institutional regulations, policies and practices related to human subject research. May supervise others.

  • Overall Project Management: Lead site visits to community settings (overnight travel required) presenting to leadership, complete enrollment steps, and create project time-lines.
  • Direct the activities of subordinate training and research staff; liaison between sites, study team, PI and University to monitor and maintain working relationships, positive communications and effective results with regard to program implementation and coordination of human subject studies.
  • Direct Evidence-Based Program Implementation: Develops and implements training curriculum to prepare Evidence-Based Program (EVP) implementers (school and UR trainer team) and trainer consultants.
  • Delivers EVPs, conducts train-the-trainer preparation, and ongoing supervision and monitoring of trainer fidelity.
  • Independently implement EVPs in multiple school settings.
  • Direct Human Subjects Research on Sites: Develops, implements, and evaluates recruitment strategies, standardized assessments with participants and data systems, as well as study management systems.
  • Recruits and enrolls participants.
  • Uses approved protocols to address safety concerns in coordination with site administrators.
  • Intervention, Study Design, Innovation: Contribute to the planning, development and refinement of each evidence-based program and study design, protocols, consent forms, processes and policies.
  • Make recommendations to principal investigators for new approaches to extending EVPs for community organization leadership, trainers, and participants.
  • Participating in writing academic papers and grants.
  • Supervisory duties: Trains and ongoing direction for research coordinators and other staff about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements.
  • Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
  • Contribute to writing reports for funding agencies and schools.
  • Financial: Transact contracts with external organizations for trainer consultants.
  • Transact school payments, track budgets, and reimburse program expenses.
  • Regulatory: Coordinates and monitors financial data for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls.
  • Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes.
  • Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines.
  • Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.
  • Bachelor's degree
  • 5 years of experience or equivalent combination of education and experience
  • Strong interpersonal and leadership skills.
  • Background in mental health and/or public health (strongly preferred).
  • Prior project management experience including leading a team to implement project protocols (preferred).
  • General knowledge of Windows, Microsoft Word, Microsoft Excel (preferred)
  • Strong organizational, communication, and interpersonal skills (preferred)
  • Human Subjects Protection Program (HSPP) and NIH' s Good Clinical Practice training prior certification (strongly preferred)
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