City of Hope Director, IACUC and Laboratory Research Protections in null, United States
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 5000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
The Research Protections Unit is responsible for the review and oversight of research involving animals, stem cells, recombinant DNA and pathogenic biologics conducted at the City of Hope. The Director for Laboratory Research Protections assures and maintains compliance with federal and state regulatory requirements for the conduct of research as well as prepares AAALAC accreditation applications and maintains accreditation. The Director for Laboratory Research Protections, reports to the Senior Director, Research Protections and is expected to collaborate with the Senior Director, Research Protections on a regular basis. The Director for Laboratory Research Protections is responsible for leading a team to facilitate research studies through research regulatory committees, including the Institutional Animal Care and Use Committee (IACUC), Stem Cell Research Oversight Committee (SCRO), Institutional Biosafety Committee (IBC) and Occupational Safety and Biohazard Committee (OSBC). The Director for Laboratory Research Protections must also coordinate with other departments and committees involved in the oversight of human subject research including the Institutional Review Board (IRB), Data & Safety Monitoring Committee (DSMC), Research Compliance, Occupational Safety and Health, Office of Sponsored Research (OSR), etc.
Key Responsibilities include:
Build relationship with internal stakeholders, including consulting with researchers and members of the Animal Resource Center (ARC). Retain and develop quality committee managers and research protocol analysts who support the SCRO, IACUC, IBC and OSBC. Liaise with research compliance and internal audit representatives as appropriate. Works with various stakeholders to build consensus and navigate the COH culture to effect change.
Research Review and Oversight
Assure that process and systems in use for the review and oversight of research involving animal, stem cells, recombinant DNA as well as pathogenic biologics are cutting-edge and consistent with industry best practices and advise the Senior Director, RPU and professional staff on issues related to Federal and State regulations involving human and protection. Identify needs for and develop additional policies, practices or initiatives to enhance the efficiency of the basic and animal research review path while maintaining compliance with federal and state regulations and requirements, AAALAC standards and other best practices. Initiate and implement policies and procedures impacting institutional compliance with Federal and state regulations relating to animal and basic research. This may include coordinating with the Analytics and Decision Support team to continue configuration and customization of the iMedRIS application which supports the SCRO, IACUC, IBC and OSBC. Serve as subject matter expert to provide advice and guidance on applicable research regulations, policies or processes to IACUC, SCRO, IBC, OSBC members and COH staff. Establishes educational opportunities and provides training to laboratory personnel and COH staff in areas covered by IACUC, SCRO, IBC and OSBC.
IACUC, SCRO, IBC and OSBC
Direct and implement procedures to ensure adequate meeting preparation and attendance. Ensures that committees are appropriately comprised of diverse and experienced members. Clarifies regulatory requirements and verifies needed information and/or documentation for committee disposition of specific studies. The Director for Laboratory Research Protections may be a voting member or ex-officio non-voting member of research oversight committees including the IACUC, SCRO, IBC and OSBC. Conduct regular evaluations of committee member participation.
Assemble the necessary Executive Committees (IACUC, SCRO, IBC, OSBC), produce a summary of the issues presented by the acts of non-compliance, summarize the Executive Committee members' discussion, outline issues that must be addressed, develop strategies based on the regulatory requirements for assessing the acts of non-compliance and Executive Committee's recommendations, prepare talking points and recommendations for the Chair to bring before the respective full Board meetings, etc. May as necessary directly contact the Institutional Official, Senior Vice President for Research Operations or the Chief Scientific Officer.
Maintain Current Assurances with OLAW
Negotiates and amends, as necessary, the COH IACUC institutional assurances with Office of Laboratory Animal Welfare (OLAW).
Accreditation and Maintenance
Prepare IACUC application and coordinates timely submission for AAALAC re-accreditation as well as any annual reports. Coordinates preparation for AAALAC inspection visits.
Serve as liaison between the COH and Federal and State agencies on matters relating to research involving animals, stem cells, recombinant DNA and pathogenic biologics, including but not limited to FDA, USDA, NIH, OLAW, CIRM, OBA. Writes and submits annual reports to federal and state regulatory and funding agencies as required. Coordinate as necessary and participates in regulatory agency site visits and audits. Analyze and assess audit findings and determine if the audit findings need to be clarified and if any corrective actions must be taken by the institution vis-à-vis committee-related findings/solutions that need to be implemented. Responsible for drafting correspondence on behalf of committees to external agencies as necessary and coordinate with research compliance.
Metrics and Reporting
Develop metrics and regular reporting for workload volume and review timelines as well as other reports as needed or requested. Distribute and publish reports to Executive Committees and senior leadership on a regular basis. Align to industry best practices and keep review timelines consistent with national metrics.
Actively participates in national research regulatory activities, e.g. national conferences. Responds to requests for comments on proposed Congressional legislation, studies and other national issues impacting research.
Minimum Education and Skills Required for Consideration:
- Must have Bachelor's degree in Health Care Administration, a scientific focus or other related field.
- Must have at least 5 years of experience managing an institutional animal care and use committee.
- Must have thorough knowledge of the USDA regulations and PHS Policy requirements for care and use of laboratory animals and working knowledge of AAALAC accreditation requirements.
- Must have administrative knowledge of the requirements for use of stem cells, recombinant DNA materials, and use of chemical and infectious hazards.
- Must have working knowledge of federal and state of California regulations governing human subjects research.
- Must have at least 5 years management experience in the area of animal or clinical research.
Preferred Education and Skills:
- Master's degree in Health Care Administration, a scientific focus or other related field.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.