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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 Manager Division of Research

Location: Oakland, CA Additional Locations:
Job Number: 833821 Date posted: 10/04/2019
Description:
This position reports to the Division of Research and
supports submissions to the IRB. It is located at the Division of Research and
does not sit within the IRB.




The DOR IRB Manager is a key member of the DOR Administration
leadership team. The position manages a team of DOR IRB analysts responsible
for reviewing, consulting on, coordinating, and processing the full range of
IRB packets (from new research applications to protocol violation reports)
prior to IRB submission. The DOR IRB Manager provides expert risk management
consultation and guidance on all regulatory and compliance aspects of DOR
research projects, including HIPAA Privacy issues, and coordinates
investigations with Regional Compliance. The position also coordinates
research-related agreements and processes (e.g., data sharing agreements,
business associate agreements, representation of activities preparatory to
research), and may serve as signatory for the agreements.





This position supervises the IRB Analysts, monitors
effectiveness, recommends streamlining opportunities and manages educational
activities. Manages regulatory aspects of small to large-scale research
projects. Works independently in accordance with established objectives.





Essential Responsibilities:



-  Manages the work of the IRB Analyst, provides
coaching, training and mentoring and recommends hiring or disciplinary actions.



-  Develops or assists in developing, implement, and
manage efficient procedures to facilitate the processing of human research
protocols in accordance with Kaiser Permanente, federal, and state policies and
procedures.



-  Conducts reviews of biomedical and behavioral
research studies in compliance with Federal regulations and Institutional
policies and procedures. Identify issues and concerns that must be addressed in
order to approve the research under the expedited procedure. Comprehension of
and ability to problem solve within the framework of federal regulations, laws,
and guidance pertaining to human subject protections, including 45 CFR 46,
21CFR50, 56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and
the Belmont Report, and the KPNCAL IRB policies and procedures.



-  Acts as point 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 of IRB support staff, IRB
members, researchers and investigators.



-  Provides guidance, advise, and counsel on matters of
general research compliance and ethical human participant research practices.



-  Serves as an expert liaison between the research
investigator and the IRB. Educate stakeholders on relevant and emerging
regulations and related risk management issues.



-  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 research coordinators and
investigators regarding applications in preparation for submission to KPNCAL
IRB.



-  Conducts educational presentations as needed.



-  Performs other duties as assigned.





Additional Information:



-  This position reports to the Division of Research
and supports submissions to the IRB. It is located at the Division of Research
and does not sit within the IRB.



-  Providing expert consultation and coordination on
research-related risk management, compliance, and HIPAA privacy issues.
Coordinating related agreements and processes (e.g., data sharing agreements,
business associate agreements, representation of activities preparatory to
research, etc.) May serve as signatory for agreements. May coordinate
investigations with Regional Compliance. 



-  Developing and disseminating IRB-related guidance in
support of Division of Research investigators and project teams, in
collaboration with DOR leadership and others. Overseeing the maintenance of DOR
IRB webpages.



-  Tracking, monitoring, and reporting on DOR IRB
submissions.



-  Demonstrated ability to exercise excellent judgment
when providing guidance and consultation, making decisions.



-  Demonstrated ability to manage to deadlines.



Education

-Bachelor's degree in science, healthcare OR 4 years of experience in a directly related field.

-High School Diploma or General Education Diploma (GED) required.

 

License, Certification, Registration

-Certified IRB Professional (CIP) or Certified IRB Manager (CIM) designation OR complete CIP/CIM certification when eligible, and ability to complete CEUs required to maintain certification.

 

Additional Requirements:

-Ability to manage several projects at once and ability to work under pressure.

-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.

-Ability to learn and master proprietary software such as IRIS, IRBNET as these programs are critical to day-to-day operations.

-Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management.

-Has the ability to supervise, advise, and counsel on matters of general research compliance and ethical human participant research projects.

-Must be able to work in a Labor/Management Partnership environment.

 

Preferred Qualifications:

-Master's degree.

 

Experience with the following:

-Developing and providing related training to stakeholders.

-Overseeing the maintenance of the DOR IRB Support Services webpages.

-Managing business systems.

-Preparing reports presentations for senior leadership and other audiences as requested.

-Deep subject matter expertise and knowledge of federal, state, and institutional requirements related to human subject-s research, including current state as well as future direction.

-Strong Management background with excellent written and verbal communication and problem-solving skills.

-Experience with the regulatory and IRB-related needs of a health care research organization of comparable size.  

Primary Location: California,Oakland,2000 Broadway 2000 Broadway Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 8:30 AM Working Hours End: 5:30 PM Job Schedule: Full-time Job Type: Standard Employee Status: Regular Employee Group/Union Affiliation: Salaried, Non-Union, Exempt Job Level: Manager with Direct Reports Job Category: Compliance / Privacy / Regulatory Department: Div of Research 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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