Director, Safety and Data Quality for Clinical Research Trials
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 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.
Under the direct supervision of the Senior Director of Research Protections, the Director, Safety and Data Quality (SDQ) is responsible for the direction, oversight and supervision of the various compents of the Office of Safety and Data Quality, including Clinical Trials Monitoring; Data and Safety Monitoring Office which supports the Data & Safety Monitoring Committee (DSMC); Auditing; Quality Assurance and Quality Control and CTRP/CT.gov & CTOL Ops and assures and maintains compliance with federal and state regulatory requirements for the conduct of research. The Director for Safety and Data Quality, reports to and collaborates with the Senior Director, Research Protections on a regular basis. The Director for Safety and Data Quality must also coordinate with other departments and committees involved in the oversight of human subject research including the Institutional Review Board (IRB); Cancer Protocol Review and Monitoring Committee (CPRMC), Protocol Review and Monitoring Committee (PRMC), 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), Research Compliance and most importantly the Clinical Trials Office (CTO) and investigators to ensure safety and data quality.
The Director, Safety and Data Quality serves as a member of the Research Protections leadership team. The Director, Safety and Data Quality strategically and proactively manages the department, including interpreting compliance requirements, on-going assessment and implementation of effective administrative processes.
- Provide supervision and leadership and oversight to each team. Serve as resource for issues. Provide training and encourage ongoing educational opportunities.
- Retain and develop high quality managers who can train and develop their staff in areas related to regulatory compliance as well as data quality and patient safety. Build relationships with internal stakeholders, including consulting with researchers and members of the protocol management team (PMT). 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. Maintain effective communication with supervisors, program leaders, faculty, managers and staff. Collaborates with CTO leadership to ensure adherence with scope of practice requirements and support of professional practice framework.
Quality & Performance Improvement
- Assure that process and systems in use for auditing, monitoring and reporting on human subject research are cutting-edge and consistent with industry best practices and advise the Senior Director, Research Protections and professional staff on issues related to relevant NIH and other Federal regulations, policies and guidance. Ensure 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 data quality and safety. This may include coordinating with the Analytics and Decision Support team to continue configuration and customization of the iMedRIS application which supports the DSMC.
- Direct and implement procedures to ensure adequate meeting preparation and attendance. Ensures that the DSMC is appropriately comprised of diverse and experienced members. The Director for Safety and Date Quality may be a member or ex-officio non-voting member of the DSMC and other research oversight committees including the C/PRMC and IRB. Conduct regular evaluations of committee member participation.
COH Institutional Data & Safety Monitoring Plan
- Responsible for the implementation and maintenance of the COH institutional Data & Safety Monitoring Plan as required by the NCI and Cancer Center Support Grant. Work with internal stakeholders to ensure the COH DSMP meets the NCI criteria as well as industry standards. Ensure updates to the DSM Plan are submitted to NCI in a timely fashion via the COH Cancer Center Associate Director for Administration
Cancer Center Support Grant (NIH Designation as a Comprehensive Cancer Center)
- Responsible for drafting the Annual Progress Reports as well as the Competitive Research Plan for the Cancer Protocol & Data Management component of the CCSG. Working with the Sr. Director, Research Protections, develop presentation materials on the progress of the CPDM component for the annual meeting of the COH External Advisory Board as well as the NCI site visitors for the competitive renewal.
In-services and orientations
- Conduct and/or coordinate in-services with departments such as the CTO, disease teams and by invitation conduct workshops, and new study team orientation. Conduct targeted training upon request or as needed as part of correction action plans to support data quality and safety in clinical trials.
- Serve as liaison as needed between the COH and external auditors/monitors on matters relating to safety, data quality and clinical trials reporting. Coordinate as necessary and participates in Federal 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. Responsible for drafting correspondence on behalf of committees to external agencies as necessary.
Metrics and Reporting
- Develop metrics and regular reporting for workload volume and data quality and protocol compliance 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 promote quality conduct of research consistent with national metrics. Create and disseminate SDQ performance summaries, scorecards, and dashboards to facilitate ongoing quality and performance improvement initiatives. Design, implement, and monitor the impact of new policies and improved processes.
- By invitation from various organizations, give talks, lectures, and conduct workshops at national conferences, such as SoCRA, PRIM&R, and AACI.
Minimum Education and skills required for consideration:
- Master's degree in Health Care Administration or related field, or Clinical Research. Experience may substitute for minimum education requirements
- Must have at least 7years progressively responsible experience related to auditing, monitoring, or conduct of clinical trials.
- Must have at least 5 years of experience related to the management and conduct of oncology clinical trials in an academic setting.
Preferred Education and skills:
- Graduate degree(s) preferred
- Certified Quality Auditor,
- Certified Clinical Research Professional
- Experience in coordinating and managing the efforts of personnel who work in the clinical trials arena.
- Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA and DHHS regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA), National Cancer Institute Cancer Center Support Grants (NCI CCSG) requirements and City of Hope Comprehensive Cancer Center programs and processes.
- Knowledge and experience in managing clinical trials.
- Knowledge of regulatory guidelines and requirements for the conduct of clinical trials and research subjects protection.
- Knowledge and experience in the clinical research environment.
- Knowledge and experience in health care setting.
- Broad knowledge of medical terminology.
- Knowledge of clinical care in a clinical research setting.
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.
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