Health Plan, Hospital, Public and Private, Research Facility
4 Year Degree
Manages regulatory aspects of small to large scale research projects. Works independently in accordance with established objectives.
Performs regulatory review and analysis of research study submissions to the Kaiser Permanente NCAL Institutional Review Board (KPNCAL IRB) for consistency, completeness, and compliance with federal and state regulations and KPNC IRB policies and procedures.
Solves routine issues within the framework of federal regulations, laws and guidance pertaining to human subject protections and the KPNCAL IRB policies and procedures.
Provides guidance and consultation regarding the interpretation of regulations, laws, and policies to researchers, staff, and research administrators related to IRB research submissions.
Advises and counsels on matters of general research compliance and ethical human participant research practices.
Staffs and coordinates the KPNC IRB by preparing and previewing items on the IRB meeting agendas, attends IRB meetings, records and writes IRB meeting minutes, and follow-up correspondence.
Consults with stakeholders, researchers, staff, IRB members and other customers on research projects. Communicates with investigators to facilitate the review process.
Provides guidance to research coordinators and investigators regarding applications in preparation for submission to KPNCAL IRB.
Peforms other duties as assigned.
Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time Kaiser Permanente reserves the right to reevaluate and change job descripitons, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees.
Minimum two (2) years in clinical research or clinical trials, clinical research compliance, and the protection of human subjects, or equivalent.
Bachelor's degree OR four (4) years of experience in a directly related field.
High School Diploma OR General Education Diploma (GED) required.
License, Certification, Registration
Ability to learn and master proprietary software such as IRIS, IRBNET as these programs are critical to day-to-day operations
Experience with Microsoft Office Professional software
Ability to independently manage several projects at once and ability to work under pressure.
Complete a medical terminology course within 6 months
Excellent interpersonal, oral, and written communication skills to work effectively with researchers, IRB staff, IRB members, senior leadership and other customers.
Ability to successfully and professionally communicate complex information to a wide variety of audiences.
Must be able to work in a Labor/Management Partnership environment.
Ideal candidates would have experience either working directly in an IRB, as a study/research coordinator, or in a regulatory environment focused on human subjects research.
Demonstrated strong interpersonal, oral and written communication skills.
IRB coordinator and/or human research regulatory coordinator experience preferred.
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation preferred or will be required to complete CIP/CIM certification when eligible.
Has working knowledge of scientific and medical concepts and terminology preferred.
NOTE: Temporary remote work from other locations may be available.
Primary Location: California,Oakland,1800 Harrison 1800 Harrison
Internal Number: 886183
About Kaiser Permanente - Northern California
Founded in 1945, Kaiser Permanente is recognized as one of America’s leading health care providers and not-for-profit health plans. We currently serve 12.3 million members in 8 states and the District of Columbia.
Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists, and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery, and world-class chronic disease management.
We are dedicated to care innovations, clinical research, health education, and improving community health.
Kaiser Permanente exists to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve.
We are trusted partners in total health, collaborating with people to help them thrive and creating communities that are among the healthiest in the nation.