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 purpose of this position is to coordinate and provide training and education in regulatory requirements and ethical standards for research involving humans and their data. The purpose of this position is also to perform preliminary ethical and regulatory analysis of research study submissions to the Kaiser Permanente Northwest Institutional Review Board (KPNW IRB) and maintain appropriate documentation of these studies to ensure compliance with research regulations and KPNW IRB policies and procedures.
Responsible for developing and providing training and education to CHR including investigators, staff,, project teams, and IRB members regarding human subjects protection and other related regulatory and ethical topics. Formats include individual or group training, development of printed or web-based materials, and others as needed. Provides expert advice and knowledge on regulatory requirements and KPNW policies and procedures. Responsible for communicating evolving regulatory and procedural standards to the research community and other stakeholders.
Reviews and evaluates research protocols, modifications, and continuing reviews to determine appropriate level of review and facilitates approvals based on federal, state and local laws and KPNW standard operating procedures pertaining to research with human subjects. Corresponds with study teams to ensure applications are clear and complete. Ensures timely processing of all submissions in order to meet deadlines and workflow standards. Serves as delegated alternate IRB member and carries out minimal risk reviews as appropriate. Uses electronic submission and data management system with accuracy to track submissions, retrieve protocol information, and retain documentation and archives in accordance with policy and regulation. Uses additional databases, electronic and paper files, etc. to facilitate operating procedures of the HRPP.
Contributes to continuous quality and process improvement efforts related to the review of human subjects protocols, including assisting with development and maintenance of policies and procedures.
Shares responsibility of coordinating and preparing for monthly IRB meetings and collecting documentation for IRB determinations. This includes conducting pre-review of submissions, assembling documents for review, distributing protocols and instructions to the Board, creating appropriate correspondence, and review follow-up. Collaborates with team by taking meeting minutes, creating agendas, and recording Board attendance, Presents training and education topics during board meetings.
Other duties as assigned.
Minimum two (2) years of experience working as an IRB Coordinator or in a similar position (e.g., working with and applying regulatory requirements pertaining to health related research).
Minimum two (2) years of experience in a position requiring managing multiple priorities and activities.
Minimum one (1) year of experience with developing and providing education or training.
License, Certification, Registration
Certification as a Certified IRB Professional (CIP), Certified Clinical Research Associate (CCRA), Certified HIPAA Professional (CHP) or equivalent certification required within 1 year of hire/transfer.
Excellent attention to detail
Working knowledge of the regulations of the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) pertaining to human subjects research
Working knowledge of the HIPAA privacy rule as it applies to research
Ability to interpret and apply ethical principles related to the participation of human subjects in research.
Excellent interpersonal skills to work effectively and diplomatically with researchers, staff, IRB members and other customers
Excellent written and oral communication skills to convey training information in a clear concise way, engaging and connecting with large or small audiences, as well as being familiar with content and learning objectives
Excellent time management and organizational skills
Ability to follow through with assignments and independently prioritize work
Ability to work well in a team-oriented environment
Ability to maintain confidentiality of information and records with tact and discretion
Advanced skills with Microsoft excel, Word, and PowerPoint
Experience working with an electronic IRB system and/or ability to organize effective record keeping and information retrieval systems
Minimum two (2) years of working in a medical or health care organization or any other covered entity subject to HIPAA requirements
Advanced degree in a research or education related field
Working knowledge of Good Clinical Practices (GCP)
Thorough knowledge of KP policies and procedures for doing research with human subjects
Thorough knowledge of philosophy and function of an IRB
Thorough knowledge of the HIPAA privacy rule as it relates to research
Internal Number: 738051
About Kaiser Permanente Northwest
At Kaiser Permanente Northwest, the work you do every day supports the health of our members. That's because each of us-from our financial,business, and IT experts, to our RNs, allied health professionals, and physicians-shares a commitment to providing the best possible care experience. Widely regarded as a mecca for outdoor enthusiasts, the Pacific Northwest blends urban bustle with open space in a way that is sure to enhance your own state of well-being. Looking to build a rewarding career in an environment that supports your success? Join us and put your beliefs into practice.
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,state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation,gender identity, protected veteran, or disability status.