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Compliance, Privacy & Regulatory

Putting Integrity Into Practice

Promoting honesty and integrity across our daily actions and interactions, our compliance, privacy, and regulatory professionals provide the guidance and resources to uphold the highest ethical standards.

IRB Administrator

Location: Oakland, CA Job Number: 715202 Date posted: 07/13/2018
Description: 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.

Essential Responsibilities:
  • 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.

  • Basic Qualifications:
  • Basic Qualifications:
  • 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
  • N/A

    Additional Requirements:
  • 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.

    Preferred Qualifications:
  • 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.

    Primary Location: California,Oakland,1800 Harrison 1800 Harrison Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:00 AM Working Hours End: 4:00 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Individual Contributor Job Category: Compliance / Privacy / Regulatory Department: Regional Compliance Office- IRB Adminsitration Travel: No
    Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.

    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 and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
  • About Compliance, Privacy & Regulatory Careers

    Compliance, Privacy & Regulatory Careers

    We've established a comprehensive, world-class compliance, privacy, and regulatory program, giving you the chance to make a difference in the lives of millions. As a member of this team, you'll engage with internal stakeholders to foster an environment of safety and trust for our members, physicians, and employees alike.

    Helping to establish and maintain an effective compliance program, you'll ensure that we operate according to the highest ethical standards and follow all applicable laws, standards, policies, and procedures. Everything we do — from developing policies and training to protecting privacy and security — reinforces our commitment to our members, regulators, and the communities we serve.

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