Management Consultant

Aptive

4d•Remote

About The Position

Aptive Resources is seeking a management consultant with demonstrated research and research administration experience to deliver high-quality project management to the Department of Veterans Affairs Office of Research and Development. This position requires strong client interaction skills and a demonstrated ability to work with various stakeholders across multiple tasks. Experience leading and managing projects in alignment with client goals, while managing resources and mitigating risks, is required for this position. The successful candidate will be highly organized, systematic, and proactive in managing quality and exceeding client expectations within a fast-paced environment. This individual will work to ensure research is conducted in accordance with regulation and/or institutional policy (e.g., FDA, IRB, NIH, VA). This position is remote. Primary site is Milwaukee, WI; if candidate lives nearby, this can be a hybrid role. Currently, this is a half-time role (16-20 hours/week), but it may expand into full-time (1 FTE).

Requirements

A Bachelor’s in health administration, public health, biomedical sciences, or a related field.
4+ years of relevant project management, research, and/or IRB experience in a healthcare environment
Ability to obtain and maintain a public trust clearance.
Legal authorization to work in the U.S.

Nice To Haves

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 the IRB as well as the rules and regulations governing safety regulations and/or animal study research (e.g., VA, FDA, IRB, and GCP regulations)
Expertise in effective training, education, and presentation techniques.
Active Certified IRB Professional (CIP) certification (or equivalent) desired but not required
Familiarity with relevant computer programs, including research management web-based software (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.

Responsibilities

Provide administrative and programmatic support for a VA Research Office
Support various research committees and initiatives, which may include the Subcommitee on Animal Studies (SAS), Subcommittee on Research Safety (SRS), 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 animal subjects and 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 SAS/IACUC and SRS, providing guidance regarding regulatory and policy requirements related to animal and safety guidelines.
Performs pre-committee analysis of Animal Component of Research Protocol (ACORP) 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 working 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.