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Kaiser Permanente Careers

Research & Development

Innovation in Practice

Operating one of the industry’s largest and most respected research programs, Kaiser Permanente employs nearly 1,800 research experts at 9 specialized centers across the country. With a research budget of $221 million and more than 2,500 studies and clinical trials underway at any given time, this is a place where you can have a profound impact on the future of health.

Research Clinical Trials Quality Assurance Reviewer

Location: Pasadena, CA Additional Locations:
Job Number: 801830 Date posted: 06/12/2019
Description:

The Clinical Trials (CT) Quality Assurance Reviewer position(s) is located at the Kaiser Permanente Southern California Department of Research & Evaluation (R & E) Clinical Trials Division. This position performs internal quality assurance and compliance auditing of clinical trials work conducted within the Southern California (SC) region to ensure accuracy, timeliness, quality of work, and compliance with all applicable federal, state, and local regulations, KPSC Institutional Review Board approvals, regulatory agency guidelines, and KP policies and procedures. This position is also responsible for consultation regarding CT compliance training and education and of CAPA follow-up and validation. This position provides CT compliance, quality, and risk management consultation to investigators in clinical trial sites across the region.  Position assists in the development of and implementation of new clinical trial quality/compliance/risk systems.  Position works in conjunction with the KPSC clinical trial investigators and CT Operations regarding ongoing cost-effective CT quality, compliance and risk activities. This position is also responsible for protecting the health, safety, and welfare of research participants.



Essential Responsibilities:

  • Conducts on site (including multi-site) clinical trial quality assurance/ compliance monitoring and provides prompt feedback to research staff and management.

  • Assists the CT Quality & Compliance Manager in the development of recommendations to the KPSC CT Quality Committee (CTQC) for corrective action plans to the CT research site and satellite sites when a confirmed quality/compliance/risk issue is identified.

  • Collaborates with audit team in the development and implementation of updates/ revisions to quality and compliance standards/monitoring systems to ensure regulatory objectives are met.

  • Works closely with the clinical trials program structure related to training, and operations functions; supports delivery of CT compliance training and education to promote a continuous learning environment.

  • Measures accuracy, comprehension, and effectiveness of training sessions and materials.

  • Provides input to the development and updating of Human Research Protections (as requested) and CT compliance training programs and supports training delivery at local research sites.

  • Seeks current information and maintains current knowledge base to assist in the development and implementation of the compliance risk management processes.

  • Develops criteria by which risk management needs within the CT program may be assessed.

  • Analyzes risk management data and makes recommendations for the incorporation of risk management principles at each CT site.

  • Promotes effective interaction among the CT research sites in the establishment of risk identification systems, including the acquisition, organization and dissemination of information, data analysis and documentation.

  • In conjunction with the CT compliance and operations management, ensures that audit processes are in alignment with research risk processes.

  • Assist in the implementation of audit controls and conducts audits to assess adherence with policies, procedures, and legal/regulatory requirements.

  • Ensures accurate and timely presentation of audit findings and recommendations to management via verbal and written reports.

  • Appropriately conducts and documents all audit processes and findings.

  • Assists in the collection and trending of data from site reports (e.g. external monitor reports, protocol violation reports, etc) and quality assurance audits.

  • Validates continued maintenance of corrective action plans and conducts compliance investigations as appropriate.

  • Compiles risk management information for dissemination to CT sites in a timely manner.

  • Provides input to the development and dissemination of best practices across the CT research program.

  • Works in conjunction with CT Quality and Compliance Manager and appropriate reporting department/staff to produce ongoing reports related to compliance, risk management, and quality.

  • May assist regional CT management in evaluating and formulating quality/risk procedures, department goals and objectives.

  • Assumes responsibility for other projects as assigned.

  • Establishes appropriate working relationships with peers.

  • Requires extensive travel in the KPSC region.

  • Must have own reliable transportation for travel.

  • Performs job functions according to the factors listed below under Job Criteria.
  • Basic Qualifications:
    Experience
  • Minimum four (4) years of experience in quality assurance/improvement and/or compliance in a health care setting required.
  • Education
  • Bachelor's degree in public health, health care administration or other related field OR four (4) years of experience in a directly related field.
  • High School Diploma or General Education Development (GED) required.
  • License, Certification, Registration
  • N/A.

  • Additional Requirements:
  • Working knowledge or experience with audit techniques, concepts and standards.
  • Willingness to obtain other certifications, if required.
  • Demonstrated knowledge of and adherence to federal, state, and other regulatory standards, requirements, and guidelines related to clinical trials research.
  • Strong working knowledge of ongoing monitoring techniques (including criteria development and trending); medical care delivery in hospital and outpatient settings; quality management principles, tools, and risk management techniques are required.
  • Effective communication and leadership skills.
  • Demonstrated excellent written and oral communication and presentation skills.
  • Strong analytical and critical thinking skills required.
  • Demonstrated ability to work in a team-based, collaborative environment.
  • Demonstrated ability to manage projects and work independently to develop creative solutions to ongoing complex issues/challenges.
  • Strong computer skills in Microsoft systems, including Word, Excel and Power Point and other web-based systems.
  • Must be able to work in a Labor/Management Partnership environment.

  • Preferred Qualifications:
  • Experience related to regulatory compliance in healthcare or related field preferred.
  • Strong knowledge of database systems preferred.
  • Current CRA certification or CCRP; CIP, preferred. 
  • BA/BSN in Nursing.
  • Experience in clinical trials and monitoring activities preferred.
  • Experience in external audits and quality assessments preferred.
  •  

    Notes:

  • This position will report to the Clinical Trials Operations Manager, Regulatory Affairs.
  • Primary Location: California,Pasadena,S. Los Robles Administration 100 S. Los Robles Ave Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:30 AM Working Hours End: 5:30 AM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Individual Contributor Job Category: Research and Development Department: Division of Clinical Trials Travel: Yes, 25 % of the Time 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 Research & Development Careers

    Careers in Research & Development

    Recognized worldwide for their scientific expertise, our researchers collect data on topics including cardiovascular disease, diabetes, mental health, and drug safety — just to name a few.

    In addition to studies centered at these facilities, our physicians and researchers conduct clinical trials of new drugs, medical devices, and other therapies through several organized centers and independently at single sites. Put together, Kaiser Permanente's research centers and scientists comprise one of the largest and most comprehensive nonacademic research programs in the United States.

    As a member of this team, you'll engage in meaningful work that has the power to affect outcomes and improve global health. Focused on areas like public-sector health services, epidemiology, and behavioral and clinical research, the work you do will ultimately allow us to improve the cost effectiveness and quality of the care we deliver — all while saving lives.

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