Kaiser Permanente IRB Analyst in Oakland, California
Conducts expedited review of biomedical and behavioral research involving human participants in the capacity of an IRB committee member like review by the convened IRB. Manages regulatory aspects of small to large scale research projects. Manages the workflow and assists IRB staff. Works independently in accordance with established objectives.
Conducts reviews of biomedical and behavioral research studies in compliance with Federal regulations and Institutional policies and procedures. Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure.
Comprehension of and ability to problem solve within the framework of federal regulations, laws and guidance pertaining to human subject protections, inlcuding 45 CFR 46, 21CFR50, 56 HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, and the KPNCAL IRB policies and procedures.
Acts a point person for scientific questions, and for decision-making and problem-solving for day-to-day IRB operations including the resolution of technical problems and questions of IRB support staff, IRB members, researchers and investigators.
Communicates with investigators to faciliate the review process while incorporatng complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any.
Provides guidance to research coordinators and investigators regarding applications in preparation for submission to KPNCAL IRB.
Serves as a primary reviewer and voting member of a convened IRB.
Conducts educational presentations as needed.
Ability to manage several projects at once and ability to work under pressure.
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 four (4) years in clinical research or clinical trials, clinical research compliance, and the protection of human subjects, or equivalent.
Minimum four (4) years of experience with federal, state, and local regulations related to protection of human subjects and applying principles regarding protection of human subjects
Minimum four (4) years of experience working in Microsoft Office suite and Electronic research systems.
- Bachelor's degree in science, health care or related field required.
License, Certification, Registration
Experience with Microsoft Office Professional software
Must be able to work in a Labor/Management Partnership environment.
Clinical research coordinator and/or human research regulatory coordinator experience IRB experience preferred.
Master's degree preferred.
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation preferred.
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.