IRB Manager Division of Research - 833821

Oakland, California

In this role, you will manage a team of Division of Research (DOR) IRB analysts responsible for reviewing, consulting on, coordinating, and processing the full range of IRB packets (from new research applications to protocol violation reports) prior to IRB submission. You will provide expert risk management consultation and guidance on all regulatory and compliance aspects of DOR research projects, including HIPAA Privacy issues, and coordinate investigations with Regional Compliance. You will also coordinate research-related agreements and processes (e.g., data sharing agreements, business associate agreements, representation of activities preparatory to research), and may serve as signatory for the agreements. In addition, you will supervise the IRB Analysts, monitor effectiveness, recommend streamlining opportunities, and manage educational activities as well as manage regulatory aspects of small to large-scale research projects and will work independently in accordance with the established objectives.

Qualifications Include:

• A bachelor’s degree in science, health care, or four years of experience in a directly related field with a high school diploma or GED; a master’s degree preferred
• Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation or complete CIP/CIM certification when eligible, and ability to complete CEUs required to maintain certification
• The ability to manage several projects at once and ability to work under pressure
• Excellent interpersonal, oral, and written communication skills to work effectively with researchers, IRB staff, IRB members, senior leadership and other customers
• The ability to successfully and professionally communicate complex information to a wide variety of audiences
• The ability to learn and master proprietary software such as IRIS, IRBNET as these programs are critical to day-to-day operations
• Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management
• The ability to supervise, advise, and counsel on matters of general research compliance and ethical human participant research projects
• The ability to work in a Labor/Management Partnership environment

Preferred Qualifications Include Experience in the following:

• Developing and providing related training to stakeholders
• Overseeing the maintenance of the DOR IRB Support Services webpages
• Managing business systems
• Preparing reports presentations for senior leadership and other audiences as requested
• Deep subject matter expertise and knowledge of federal, state, and institutional requirements related to human subject research, including current state as well as future direction
• Strong Management background with excellent written and verbal communication and problem-solving skills
• Experience with the regulatory and IRB-related needs of a health care research organization of comparable size