Position Summary and Key Responsibilities:
The Director Research Protections is responsible for the review and oversight of all human subject research conducted at the City of Hope and its community practices. The Director for Clinical Research Protections assures and maintains compliance with federal and state regulatory requirements for the conduct of research as well as prepares AAHRPP (Association for the Accreditation of Human Research Protection Programs) applications and maintains accreditation. The Director for Clinical 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 Clinical Research Protections is responsible for planning, directing and coordinating the Research Subjects Protection program and leading a team to facilitate research involving human subjects through the research regulatory committees -- Cancer Protocol Review and Monitoring Committee (CPRMC), Protocol Review and Monitoring Committee (PRMC) and Institutional Review Board (IRB). The Director for Clinical Research Protections must also coordinate with other departments and committees involved in the oversight of human subject research including the Data and Safety Monitoring Committee (DSMC), Institutional Biosafety Committee (IBC--recombinant DNA research including human gene transfer), Radiation Safety Committee (RSC) and the Stem Cell Research Oversight (SCRO) Committee, Conflict of Interest and Commitment Committee (COICC) to ensure reviews are conducted efficiently.
Build relationship with internal stakeholders, including consulting with researchers and members of the protocol management team (PMT). Retain and develop quality committee managers who oversee the Research Protocol Analysts (RPAs). Retain and develop Managers and RPAs for the IRB and CPRMC/PRMC. 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.
Human Subject Research Review and Oversight
Assure that process and systems in use for the review and oversight of human subject research 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. Identifies needs for and develops additional policies, practices or initiatives to enhance the efficiency of the human subject research review path while maintaining compliance with the Cancer Center Support Grant requirements, federal and state regulations, and AAHRPP standards. Initiate and implement policies and procedures impacting institutional compliance with Federal and state regulations relating to scientific review and human subject research. This may include coordinating with the Analytics and Decision Support team to continue configuration and customization of the iMedRIS application which supports the CPRMC/PRMC and IRB.
Direct and implement procedures to ensure adequate meeting preparation and attendance. Ensures that committees are appropriately comprised of diverse and experienced members. The Director for Clinical Research Protections may be a member or ex-officio non-voting member of research oversight committees including the C/PRMC and IRB. Conduct regular evaluations of committee member participation.
Assemble the necessary Executive Committees (IRB, CPRMC/PRMC), 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.
In-services and orientations
Conduct and/or coordinate in-services with departments, disease teams and by invitation conduct workshops, COH Responsible Conduct of Research Seminar Series and new committee member orientation.
Serve as liaison between the COH and Federal and State agencies on matters relating to human subject protections. 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 IRB-related findings/solutions that need to be implemented. Responsible for drafting correspondence on behalf of committees to external agencies as necessary. Coordinate reviews with externally designated IRBs including, but not limited to NCI CIRB and Western IRB, as well as other Single IRBs as required by NIH requirements
AAHRPP Accreditation & Maintenance
Working with the Senior Director, Research Protections who serves as the Director of the COH HRPP, direct and coordinate the timely applications for accreditation and re-accreditation for Human Research Protection Program, as well as the annual reports. Promote and implement efficiencies consistent with best industry practices.
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.
Maintain current Assurances and IRB Registrations with OHRP, FDA and DOD, as applicable
Maintain current Federal Wide Assurance (FWA) for human subjects research with OHRP as well as DOD agencies as applicable. Ensure COH designated IRBs are appropriately registered.
By invitation from various organizations, give talks, lectures, and conduct workshops at national conferences, such as PRIM&R, NCCN Directors Meeting, and AACI.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested. Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Master’s degree. Experience may substitute for minimum education requirements.
- 5-10 years personnel and administrative management experience within the context of research regulations.
- Certified IRB Professional is preferred.
- Knowledge and understanding of 45 CFR 46 (HHS), 21 CFR 56, 50, 312, 812 (FDA), Title 17 (California Health and Safety Code), accreditation requirements (such as AAHRPP), 45 CFR 160 & 164 (HIPAA research regulations), Cancer Center Support Grant (CCSG) Guidelines and other NIH requirements related to human subject research, working knowledge of information systems relating to the management of committee review and oversight of research, as well as competency in public/group speaking.