Experience:

• 4+ years of IRB management and study reviews. The successful applicant will have experience in conducting reviews of a wide variety of protocols as well as experience managing an IRB.
• Knowledge of both biomedical and social/behavioral human subjects research. Knowledge of IACUC and IBC a plus but not required.
• Full command of common rule and an understanding of the FDA regulations, as well as knowledge of where to find regulatory guidance and documents.
• Experience with online IRB management systems (experience with Mentor IRB a plus).
• General knowledge of data management: for example, experience with spreadsheets as a tool for data transfer and data management. General knowledge of databases is a plus (but we can teach the job specific skills). We are not looking for programming abilities, just a general understanding of data management so that the applicant can think in terms of how data is managed and stored in an online system.

Qualities:

• Excellent people skills to work with a wide variety of clients and staff (investigators, client IRB staff, development team). Ability to work patiently and diplomatically with users of widely varying abilities.
• Clear and concise writing ability: writing instructions to clients for support requests; writing “how to” guides, describing new features to development team.
• Strong computer skills: Internet, Word Processing, Spreadsheets, etc.
• Ability to learn

Self-motivated and ability to work independently

General Parameters of Work:

• Work directly with the Chief Product Officer on implementation of new clients in the Mentor IRB software system with the goal of becoming independent to manage implementation with new clients. Implementation is not just a matter of configuration of software: it is a collaborative and consultative process of learning the client IRB’s needs, their current processes and advising them on best practices and how to implement their policies and procedures into a flexible online system.
• Handle support requests as they come in. Support requests are handled by email, phone and/or Skype/GoToMeeting as required.
• Conduct training (mostly online, occasionally in person) with new clients.
• Develop general guidance and help documents and short tutorial videos.
• Translate client needs into ideas for new features and translate these ideas into instructions for development of new features for the programmers.
• Review and test new features in the Mentor IRB system.
• Option to work in our Remote Protocol Management This service provides Axiom Mentor staff to clients for conducting protocol reviews and providing IRB management services (remotely) to Mentor IRB clients who contract with us for this service.