Director IRB Administration

Kaiser Permanente

Location: remote or Oakland, California

When you join Kaiser Permanente, you’ll be part of an organization dedicated to total health. At every level and in every department, it’s what we stand for. By using your innovation and your creativity, you can play a role in the health of communities across town and around the country by serving 12.5 million of our members. No matter your background, your ideas can help drive a health care pioneer. You can play a role in the future of health.

Director IRB Administration
Oakland, California

Provides administrative leadership and direction to the operational aspects of a large regional institutional review board, overseeing all IRB submissions from TPMG physician researchers, and KPNC HP/H non-physician researchers in a manner that effectively maximizes quality and compliance with federal and state regulatory research standards, participant safety, KP policy, and staff satisfaction. In collaboration with and under the supervision of the Director Human Research Protections, provides supervision to a medium size professional research compliance staff and oversight of the research infrastructure to assure compliance with federal, state, and local regulations across the region.

Essential Functions:
• Management, Training and Development: Supervises the Northern California IRB staff and oversees the IRB budget. Coordinates the continuing process of training and developing the IRB staff, IRB Members, and investigators and their staffs.
• Regulatory and Compliance Functions: Maintains an in-depth knowledge of changing federal, state and local regulations and organizational policies pertaining to human research subject protections. Assures the KPNC IRB is in compliance with Federal and State regulations and Kaiser Permanente policies. Reports serious/continuing noncompliance with regulations, unanticipated problems involving risks to subjects or others, and suspension/termination of IRB approval to institutional officials, federal government and others, as required. Applies regulatory review criteria and initial categorization of the level of IRB review.
• Information Systems Management: Serves in an advisory role in to management and improvement of the electronic IRB system (IRBNet). Oversees maintenance of accurate IRB records.
• Operations: Communicates with hundreds of clinical and non-clinical investigators, research staff, two IRB Chairs and IRB members to answer questions, provide advice and/or direction, resolve problems and provide proactive guidance and training. Provides support to investigators by assuring the accuracy of submissions and responds to investigators regarding deficiencies, inconsistencies or concerns. Serves as liaison between investigators and IRB staff regarding the IRB policies or IRB activities. Participates in the development of new policies and standard operating procedures. Ensures implementation and oversees management of policies and procedures. Coordinates the selection, orientation and training of new IRB members. Serves as a member on the Northern California IRB. Participates in the KP National IRB Leadership Group.
• Continuous Quality Improvement: Develops and implements a quality management plan for the work processes of the Northern California IRB staff.
• Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, 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 seven (7) years in research compliance, research design, clinical trials, health care, public health, the protection of human subjects, or equivalent.
• Minimum seven (7) 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 seven (7) years of experience with federal, state, and local regulations related to protection of human subjects.
• Minimum seven (7) years of experience in project and people management.
• Minimum five (5) years of experience working in Microsoft Office suite and Electronic research systems.
Education
• A Bachelor's degree in public health, law, social science, business, management or related field.
Additional Requirements:
• Demonstrated ability to write concisely and effectively.
• Working knowledge of medical or health-related research, medical terminology.
• Demonstrated aptitude for self-motivation, collaboration.
• Proven management skills for multiple priorities and activities with demonstrated attention to details.

Preferred Qualifications:
• A Master's degree in public health, law, social science, business, management or related field.
• Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation preferred.

For immediate consideration, please visit http://kp.org/careers for complete qualifications and job submission details, referencing job number 1049989.

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.

This position supports Kaiser Permanente’s code of conduct and compliance by adhering to all laws and regulations, accreditation and licensure requirements, and internal policies and procedures.

kp.org/careers

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