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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 Analyst

Location: Oakland, CA Additional Locations:
Job Number: 814137 Date posted: 08/13/2019
Description:

Manages regulatory aspects of small to large scale research projects. Works independently in accordance with established objectives.



Essential Responsibilities:

  • 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.

  • Basic Qualifications:

    Experience

  • Minimum two (2) years in clinical research or clinical trials, clinical research compliance, and the protection of human subjects, or equivalent.
    Education

  • 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

  • N/A

     

    Additional Requirements:

  • 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.

     

    Preferred Qualifications:

  • 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
  • preferred.
  • Ideal candidates would have experience either working directly in an IRB, as a study/research coordinator, or in a regulatory environment focused on human subjects research.
  • Demonstrated strong interpersonal, oral and written communication skills.
  • Has a working knowledge of scientific and medical concepts and terminology.  
  • Experience reviewing Exempt and/or Expedited research. 
  • 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: 4:30 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: Institutional Review Board (IRB) 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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