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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.

Program Manager, Human Subject Research Protection Program

Location: Seattle, WA Additional Locations:
Job Number: 824058 Date posted: 08/23/2019
Description:

The purpose of this position is to a) develop a quality improvement (post-approval) monitoring program, coordinate and conduct monitoring of ongoing research studies, and training in regulatory requirements and ethical standards for research involving humans and their data; (b) perform ethical and regulatory analysis of research study submissions to the Kaiser Permanente Washington Institutional Review Board (KPWA IRB) and maintain appropriate documentation of these studies to ensure compliance with research regulations and KPWA IRB policies and procedures; (c) assist with the development, coordination, and management of individual projects for Human Subjects Research Protection Program.



Essential Responsibilities:

Human Research Protections Program, Quality Improvement Program


  • Develop, implement, and manage a quality-improvement (post-approval) monitoring program. The individual will be responsible for overseeing research monitoring activities in collaboration with internal and external research stakeholders. Responsibilities include developing reports, conducting monitoring visits, (including discussing results with the study PI and project team members), coordinating implementation of research compliance efforts, and assisting with regulatory compliance through monitoring regulatory changes, and program evaluation. Includes escalating high priority issues or risks as appropriate and providing input on corrective action plans. Serve on regional and national working groups.  

    Human Research Protections Program, Project Management

  • Under the oversight of the HRPP Director, the HRPP Program Manager manages key initiatives and special projects for the Human Research Protection Program, such as ongoing development of guidance and SOPs, training and education, compiling research compliance reports, program assessment, creating data management systems, and tracking team goals. Serves on KPWA committees and working groups.
    Institutional Review Board


  • Use advanced research compliance concepts to interpret and apply a wide variety of highly complex federal, state and institutional policies, regulations and guidelines to research projects submitted KP Washington Region IRB. Make determinations and communicate decisions to project teams. Provide consultation, mentoring, and training to KPWA Scientific Investigators and relevant project staff on the appropriate application of federal, state and institutional research policies and regulations. Serve as a Committee member of the Human Subjects Review Committee. Serve on regional and national working groups.

    Professional Development

  • Practices self-development and promotes learning in others by proactively providing information, resources, advice, and expertise with coworkers and customers; building relationships with cross-functional stakeholders; influencing others through technical explanations and examples; adapting to competing demands and new responsibilities; listening and responding to, seeking, and addressing performance feedback; providing feedback to others; creating and executing plans to capitalize on strengths and develop weaknesses; supporting team collaboration; and adapting to and learning from change, difficulties, and feedback. Maintain up-to-date knowledge of federal, state, and institutional policies concerning research compliance.

  • Basic Qualifications:

    Experience

  • Minimum three (3) years of experience with federal, state, and local regulations related to protection of human subjects and applying ethical principles regarding protection of human subjects.
  • Minimum three (3) years of experience working in human subjects research, including research design and data management.
  • Minimum three (3) years of experience with project management.
  • Minimum two (2) years of experience with developing and providing education or training.

  • Minimum two (2) years of experience in a medical or health care organization or any other covered entity subject to HIPAA requirements.

    Education


  • Bachelor's degree in a health science, clinical, legal, or public health field OR bachelor's degree in an unrelated field AND four (4) years of directly related experience.

    License, Certification, Registration

  • N/A


    Additional Requirements:

  • Excellent interpersonal skills to work effectively and diplomatically with researchers, staff, IRB members and other stakeholders.
  • Excellent written and oral communication skills.
  • Advanced skills with Microsoft excel, Word, and PowerPoint.
  • Excellent attention to detail and organizational skills.
  • Ability to work well in a team-oriented environment.

  • Ability to maintain confidentiality of information and records with tact and discretion.



    Preferred Qualifications:

  • Experience as Institutional Review Board staff.
  • Experience with auditing or monitoring research studies for human subjects compliance.
  • Thorough knowledge of the HIPAA privacy rule as it relates to research.
  • Experience writing policies, procedures, and guidance.
  • Experience in leadership role with or without direct reports.

  • Experience working cross-functionally across departments, functions, or business lines.


  • Advanced degree.
  • Primary Location: Washington,Seattle,Met Park East 1730 Minor Ave. Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon - Fri Working Hours Start: 9:00 am Working Hours End: 5:00 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: Research and Development Department: Human Research Protection Program/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 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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