Under the direction of the IRB Senior Manager, the IRB Analyst II is responsible for assisting with the board operations of the Kaiser Permanente Interregional Institutional Review Board (KPiIRB) to ensure compliance with federal and state laws, regulations, guidelines, and institutional policies to protect human subjects in research. Manages regulatory aspects of small to large scale research projects. Works independently in accordance with established objectives.
This position is remote but will need to be based in any of our KP Regions: WA, OR, CA, CO, GA, HI, and VA, MD, DC
The IRB Analyst II will do the following:
Performs regulatory review and analysis of research study submissions to the KPiIRB for consistency, completeness, and compliance with federal and state regulations and KPiIRB policies and procedures.
Solves routine issues within the framework of federal regulations, laws and guidance pertaining to human subject protections and the KPiIRB 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 KPiIRB by preparing and previewing items on the IRB meeting agendas, attends IRB meetings, records, and writes IRB meeting minutes, and follow-up correspondence, as assigned.
Consults with stakeholders, researchers, staff, IRB members and other partners 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 the KPiIRB.
Performs other duties as assigned.
Kaiser Permanente conducts compensation reviews of positions on a routine basis.
Minimum three (3) years in clinical research or clinical trials, clinical research compliance, the protection of human subjects, or internal review board, or equivalent.
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 work in a high volume fast paced work environment.
Must be organized and re-prioritize tasks as needed and be flexible.
Kaiser Foundation Research Institute (KFRI) is a national program that was established in 1958 by the KP Health Plan/Hospitals Board of Directors to administer and support research in KP. Supporting a system of nine IRBs, KFRI holds the Federalwide Assurance for human subjects protection for all KP Regions.
KFRI, on behalf of all regional KP research organizations, reviews and submits all applications for federal research funds and executes all contracts and subcontracts involving federal funds. As the fiscally responsible party, KFRI also is the authorized recipient of all federal research funding awarded to KP.
KFRI, sometimes in collaboration with other KP departments and groups such as the regional research departments, National Legal, National Compliance, and National Controller, offers comprehensive review and support services to investigators to ensure compliance with federal regulations.