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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.

Institutional Review Board (IRB) Specialist

Location: Aurora, CO Additional Locations:
Job Number: 838585 Date posted: 10/23/2019
Description:
The Human Research Participant Protection Program (HRPPP) Administrator is a member of the Kaiser Permanente of Colorado (KPCO) Institutional Review Board (IRB) and works in collaboration with the KPCO IRB Chair and the IRB Coordinator. The HRPPP Administrator collaborates with the KPCO RRC Chair and RRC Coordinator/Administrative Support. This position assists in the administration of the KPCO HRPPP with the HRPPP Director. The KPCO HRPPP supports the KPCO IRB and is responsible for assuring that appropriate steps are taken to protect the rights and welfare of human subjects participating in biomedical and behavioral research. This position is accountable for creating a culture of compliance, ethics and integrity. Maintains knowledge of and assures departmental compliance with Kaiser Permanente's Principles of Responsibility and policies and procedures, and applicable regulatory requirements and accreditation standards. Responds appropriately to observed fraud or abuse.


Essential Functions:

- Coordinate activities of the KPCO IRB with investigators, Board members and affiliated institutions.
- Manage the process for ensuring appropriate documentation of all aspects of the KPCO IRB and Privacy Board for the Health Insurance Portability and Accountability Act (HIPAA) to ensure accuracy and compliance with federal regulations, appropriate state laws, KP policies and procedures, and the HIPAA Privacy Rule pertaining to research with human subjects.
- Prepare and disseminate timely written notifications to investigators (and designees) regarding IRB actions.
- Coordinate the collection and preparation of materials for IRB meetings and ongoing review.
- Develop, implement, and/or oversee orientation and education of investigators and IRB members in the protection of human subjects participating in human subjects research, in compliance with federal and local regulations.
- Coordinate the timely and complete written/computerized records that document the decisions and operations of the KPCO IRB in compliance with institutional policies and any applicable federal regulations.
- Develop and maintain knowledge of IRB regulations and accreditation standards, KPCO IRB and RRC Standard Operation Procedures, CRU Standard Operating Procedures.
- Coordinates other IRB activities, e.g., federal audits, discussions with investigators and communications with research subjects.
- Oversee IRB tracking and documentation systems.
- Serve as a resource to the institution, KPCO IRB and investigators regarding current and developing FDA and OHRP regulations and HIPAA Privacy Rule laws regarding the participation and protection of human research subjects.
- Other duties as assigned.
- Maintain current information and knowledge of all applicable Kaiser policies, local, state and federal laws and regulations, and accreditation standards.
- Ensures that the training activities incorporate all applicable KP policies, local, state and federal laws and regulations, and accreditation standards.

Basic Qualifications:
Experience
- Minimum two (2) years of experience in an IRB related position.
Education
- Bachelor's degree in public administration or health care related field is required.
License, Certification, Registration
- N/A


 


Additional Requirements:
- Outstanding verbal and written communication skills and human relations skills.
- Excellent project management, time management, problem solving and customer service skills.
- Proficiency in relational databases, spreadsheets and word processing applications is required.
- Ability to interpret and apply federal regulations and organizational policies and procedures relative to the administration of research activities.
- Strong work group, staff member, team and committee leadership and management skills.



Preferred Qualifications:
- Minimum three (3) years of experience in clinical or health services research is preferred.


- Master's or doctoral degree preferred.
- Current CIP and/or CIM designation preferred.

Primary Location: Colorado,Aurora,Waterpark II 2530 S. Parker Rd. Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon - Fri Working Hours Start: 8:00 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: Compliance Travel: Yes, 5 % 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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