Kaiser Permanente Associate Director Human Research Protection in Pasadena, California
Provides leadership for and operationalizes Kaiser Permanente's (KP) Human Research Participant Protection Program (HRPPP); ensures regulatory compliance, human subjects protection, and quality improvement for the HRPPP; provides guidance and implements best practices as they relate to HRPPP staff throughout KP, the nine KP Institutional Review Boards (IRBs), and KP investigators and research staff; develops and administers policies and procedures for the protection of human subjects in research, and assures institutional compliance with applicable federal and state regulations.
Essential Functions: - Provides consultation with institutional leaders, FWA Institutional Official, IRB Chairs and Administrators, researchers, and other research stakeholders on complex research issues. - Resolves questions or conflicts and provides clarifications regarding regulatory or policy matters related to the HRPPP. - Collaborates with multiple stakeholders and IRBs to maximize efficiency while improving human subject protection to facilitate multiregional research - Supervises staff and oversees systems to track and report IRB Authorization Agreements, Independent Investigator Agreements, regulatory agency communications, GINA (Genetic Information Nondiscrimination Act) Notices of Research Exception; as well as systems to revise and renew the KP FWA and IORG. - Assists HRPPP Director to develop annual KP IRB Leadership meeting program and develops agenda, leads, and documents monthly KP IRB Administration conference calls - Monitors and analyzes new legislation, federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community and implement effective strategies to ensure KP HRPPP compliance, including drafting, updating, and monitoring KP HRPPP Standard Operating Procedures. - Updates appropriate contacts on latest regulatory and policy developments - Establishes and implements strategies for quality assurance activities, including HRPPP review activities and other quality assurance and quality improvement (QA/QI) activities. - Monitors HRPPP and other data sources to assure internal quality, consistency of information, and adherence to regulatory timelines and requirements. - Coordinates quality assurance and improvements with other groups as required. - Advises the FWA Institutional Official of unanticipated problems involving risks to human subjects or others and alleged and documented serious and/or continuing non-compliance. - Supports activities of the KP regional IRB Directors, Administrators, and Chairs and works to ensure consistent practices across KP. - Collaborates with the Education and Training on the delivery of HRPPP training. - Advises FWA Institutional Assurance Official on KP Certificate of Confidentiality applications, IRB Authorization Agreements, Independent Investigator Agreements - Develops and maintains important strategic relationships with federal regulators. - Represents the KP HRPPP at internal and external meetings as required - Develops and maintains contacts with peers at other institutions, monitors on-going national discussions on regulatory and ethics issues.
Qualifications: Basic Qualifications: Experience - Minimum ten (10) years of work experience. - Minimum five (5) years of IRB management experience. - Minimum three (3) years of supervisory experience. Education - Bachelor's degree with clinical qualifications (eg, RN, NP), OR - Master's or doctoral degree. License, Certification, Registration - Certified IRB Professional (CIP) designation required within one (1) year of appointment to the position.
Additional Requirements: - Working knowledge of regulations related to human subjects research (e.g., Common Rule, FDA IND/IDE regulations, ICH GCP, HIPAA, GINA). - Proficiency with computer work, including Microsoft Office. - Must be able to work in a Labor/Management Partnership environment.
Preferred Qualifications: - Minimum ten (10) years of work experience preferred. - Minimum seven (7) years of experience in clinical research preferred. - Work in large organizations preferred. - Consensus-driven management style preferred. - Outside the box thinking, but able to maintain regulatory compliance preferred.
COMPANY Kaiser PermanenteTITLE Associate Director Human Research ProtectionLOCATION Pasadena, CAREQNUMBER 626758
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.