Kaiser Permanente IRB Administrator in Oakland, California
The IRB Administrator is instrumental in the support of the IRB Operations, to meet its primary responsibility of protecting the rights of human research subjects. This position manages regulatory aspects of small to large-scale research projects and direct interaction with IRB board, investigators as well as clients in an administrative capacity. Leads IRB staff and assists IRB members as needed. 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.
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.
Serves as a primary point of contact and subject matter expert to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections and the KPNCAL IRB policies and procedures.
Acts as point of 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 o fIrB support staff, IRB members, reserachers and investigators.
Leads, advise, and counsel on matters of general research compliance and ethical human participant research practices
Provides educaton and guidance to IRB members to assure that the board is equipped with current tools to protect the safety and welfare of human subjects in research.
Independently composes and edits complicated sensitive correspondence, reports and documents related to outcomes and findings of the human subject protection programs. Prepares, analyzes and summarizes data from IRB activities.
Communicates with investigators to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any.
Provides guidance to staff, research coordinators and investigators in interpreting and applying regulations, policies and guidance for protocol review, or 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.
Manages small to large-scale projects in a high volume fast paced work environment.
Provides back-up to IRB Manager as assigned.
Performs other duties as assigned.
Minimum four (4) years in clinical research or clinical trials, clinical research compliance, the protection of human subjects, or internal review board
Bachelor's degree in science, healthcare OR four (4) years of experiience in a directly related field.
High School Diploma or General Education Diploma (GED) required.
License, Certification, Registration
Has the ability to investigate, comprehend, and interpret applicable federal, and state policies and procedures and communicate these to stakeholders.
Ability to learn and master proprietary software such as IRIS, IRBNET as these programs are critical to day-to-day operations.
Intermediate or advanced level competencies with Microsoft Office suite (Outlook, Word, Excel).
Demonstrates strong interpersonal, oral and written communication skills.
Ability to independently manage several projects at once and ability to work in a high volume fast paced work environment. Must be organized and re-prioritize tasks as needed, and be flexible.
Must be able to work in a Labor/Management Partnership environment.
Clinical research coordinator and/or human research regulatory coordinator experience, IRB experience preferred.
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation preferred or will be required to complete CIP/CIM certification when eligible, and ability to complete CEU's required to maintain certification.
Master's degree preferred.
TITLE: IRB Administrator
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.