Kaiser Permanente IRB Analyst in Oakland, California
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 Baord (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.
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation preferred or
will be required to complete CIP/CIM certification when eligible.
IRB coordinator and/or human research regulatory coordinator experience preferred.
Has working knowledge of scientific and medical concepts and terminology
Additional Preferred Qualifications:
Has a working knowledge of scientific and medical concepts and terminology.
Experience reviewing Exempt and/or Expedited research.
Ideal candidates would have experience working in an IRB or regulatory department and providing either regulatory or administrative support to an IRB Committee.
Demonstrated strong interpersonal, oral and written communication skills.
TITLE: IRB Analyst
LOCATION: Oakland, California
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.