PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The IRB Specialist is a member of the Kaiser Permanente of Colorado (KPCO) Institutional Review Board (IRB) and works in collaboration with the KPCO IRB Chair, Director and the IRB Coordinator. This position assists in the administration of the KPCO HRPP. 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.
- 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 Standard Operation Procedures, IHR 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.
-Complete expedited reviews. - 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.
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
Internal Number: 838585
About Kaiser Permanente Colorado
As a member of Kaiser Permanente Colorado's team, you'll be proud of the contributions you make every day.
We work together to improve the health of our members, coworkers, and the communities where we work and live. Whether you join us in the metro areas of Denver and Boulder or in Front Range communities from Fort Collins to Pueblo, you'll enjoy breathtaking natural beauty of the Rocky Mountains along with urban flair.
The areas we serve offer something for everyone-historic districts, family neighborhoods, and access to some of the best hiking, biking, kayaking, fishing and ski resorts in the world. Prepare to be inspired.
Immediate Opening: Excellent Benefits, Competitive Salary
Full Time Opportunity, Denver Regional Offices – Denver, CO
• Free Medical Benefits
• Tuition Reimbursement
• Pension Plan
• Sick Days
• Work Life Balance