Note: The job is a remote job and is open to candidates in USA. Aptive Resources is seeking a management consultant to deliver high-quality project management to the Department of Veterans Affairs Office of Research and Development. The role involves providing administrative support for various research committees, processing research proposals, and ensuring compliance with regulatory requirements.

Responsibilities

• Provide administrative and programmatic support for a VA field research Office, primarily related to the Subcommittee on Research Safety (SRS), but also potentially interacting with other committees such as the Institutional Animal Care and Use Committee (IACUC), and the Research and Development (R&D) Committee. Tasks may include creating agendas in IRBNet, taking meeting minutes, and entering data into IRBNet following committee meetings, as appropriate
• Process research proposals involving the use of hazardous biological or chemicals in medical research, including receipt, logging, routing, tracking, inquiry, evaluation, review, action and response
• Review annual continuation requests, process administrative approvals, incident reporting, and semi-annual external reports
• Coordinate communication between research committees, providing guidance regarding regulatory and policy requirements related to safety guidelines
• Perform pre-committee analysis of research protocol and Safety Survey forms, including contacting investigators and requesting additions or corrections
• Conduct database administration, audits, and project tracking through IRBNet and Excel spreadsheets
• Use IRBNet to process, track, and document research projects and send out committee decision letters
• Communicate deficiencies/inconsistencies found in the IRBNet entries to research team and work with the team to ensure that all documents are complete and accurate
• Support the Research Office to conduct audits of regulatory documents
• Provide IRBNet training to VA research staff, PIs, and other researchers
• Field general and regulatory questions from investigators and study teams
• Use checklists and instructions to verify completeness of protocol submissions

Skills

• A Bachelor's degree in related field such as health administration, public health, or biomedical sciences
• 4+ years of relevant project management, research, and/or research oversight committee experience (e.g., R&DC, SRS, IACUC, IRB) in a healthcare environment
• Ability to obtain and maintain a public trust clearance
• Legal authorization to work in the U.S
• Experience with VA/DoD and knowledge of military populations
• High level of experience and comfort working independently with senior leadership, faculty, staff, students, medical professionals, and external agencies in complex organizations
• Advanced knowledge of the scope and function of Research Safety Committee regulations and compliance (e.g., VA Research Guidelines, Directives, and Handbooks)
• Ability to support research committee administration and management (e.g., submission processing, draft meeting agenda and minutes, facilitate meetings, communicate with PIs and committee members, generate determination letters)
• Expertise in effective training, education, and presentation techniques
• Familiarity with relevant computer programs, including research management web-based software (VAIRRS/IRBNet experience preferred) and Microsoft Office suite, including SharePoint data/electronic file management tools
• Attention to detail and competent application of English grammar and punctuation
• Ability to work well under pressure, multi-task, and manage deadlines
• Must possess discretion and mature judgment, as confidential information is routinely encountered

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