Senior Director, Clinical Trials Office

Requisition ID: 9077

Job Title: Senior Director, Clinical Trials Office

Position Summary and Key Responsibilities:

Under the direct supervision of the Senior Vice President of Research Operations, the Senior Director, Clinical Trials Office (CTO) is responsible for the development, implementation, coordination, and leadership (administrative/organizational, regulatory, and financial) of all clinical research teams and interventional clinical trial portfolios managed within the Clinical Trials Office (CTO). The Senior Director, Clinical Trials Office will supervise the disease focused clinical research disease based directors and managers, the Manager of Multi-Center Operations, and Director of Regulatory Support Services. S/he provides key leadership for the clinical research enterprise development and guidance into resource allocation which aligns with national and institutional benchmarks. This position will collaborate with principal investigators and the clinical research team to ensure that all federal/state/local regulatory requirements are followed. S/he drives processes to ensure that institutional operational research objectives are met and that ethical obligations to research care provision are kept.

The Senior Director, Clinical Trials Office develops and maintains productive relationships with the research and clinical community at City of Hope. S/he provides oversight to achieve optimal research outcomes and collaborates with strategic planning initiatives focused on increasing clinical research provision. To this end, the the Senior Director, Clinical Trials Office works closely with the Senior Director of Research Protections, Senior Director of the Clinical Research Unit & Affiliate Practices and Senior Director of Clinical Research Services in strategically and proactively managing the department, including interpreting compliance requirements, day to day financial planning and annual budget production, on-going assessment and implementation of effective operational processes which support the current technology platforms of EPIC and OnCore.

Essential to this role is to provide management and oversight for the multidisciplinary disease teams housed in the CTO, the regulatory support services, and the multicenter study operations at City of Hope. The Senior Director, Clinical Trials Office in conjunction with the Senior Director, Research Protections ensures that audits are conducted in accordance with the clinical trial auditing standard operating process (SOP) and with established external best practices. S/he is also responsible for maintaining an ongoing monitoring program that contributes to the success of clinical trials conducted at City of Hope from the standpoint of regulatory requirements, good clinical practice, data quality, protocol compliance, protection of human subjects, and overall quality assurance.

The Senior Director, Clinical Trials Office also facilitates efficient and effective communication between each modality / disease research team(s) and its clinical research infrastructure / support service providers as it relates to the COH community clinics and affiliate research sites. The Senior Director assures that all COH clinical research meets the highest standards for speed, safety, effectiveness, and quality in a manner that enhances the clinical reputation of the organization both nationally and internationally. The position requires close collaboration with the Associate Director, for Developmental Therapeutics and Translational Research, the Medical Director of the Clinical Trials Office as well as the Medical Director, Clinical Research Unit for the City of Hope's comprehensive cancer center to achieve these objectives:

  • Demonstrate expertise in a variety of fields related to the conduct and management of a robust and vibrant clinical oncology portfolio which encompasses all study phases and to a lesser extent HIV/AIDS and Diabetes research.
  • Rely on experience, expertise and judgment to define and accomplish goals.
  • Facilitate communication among leaders and stakeholders at all organizational levels.
  • Lead and direct the work of others to oversee the conduct innovative clinical trials and advance the standard of care towards best practices in clinical research.
  • Development and effective implementation of performance metrics which drive cost efficiency and optimal results

Essential Functions:

Operational Management

  • Oversee the audit the conduct of clinical trials for protocol compliance, adverse event reporting, compliance with internal and external regulatory requirements, and GCP/ICH guidelines.
  • In collaboration with the Associate Director, for Developmental Therapeutics and Translational Research, the Medical Director of the Clinical Trials Office as well as the Medical Director, Clinical Research Unit, evaluate and optimize clinical research modality / disease research team(s) in terms of, performance, compliance, and resource utilization.
  • Develop, deploy, and revise SOPs as necessary to (1) proactively detect, eliminate and prevent regulatory compliance issues (2) minimize institutional risk (3) improve research subject safety and (4) maximize cost recovery
  • Confirm that subordinates receive all necessary operational and educational training required to understand and comply with operational expectations.
  • Ensure that CTO processes are well-integrated with the IRB's processes.
  • In conjunction with the Senior Director of Research Protections ensure that the CTO's process and procedures for identifying potential non-compliance or unanticipated problems align with the IRB's requirements for reporting allegations of non-compliance, unanticipated problems, findings of serious or continuing noncompliance, etc.
  • Address issues of non-compliance with the Senior Director of Research Protections to better integrate regulatory clinical trial activities and enhance the quality of the clinical trials that are conducted at COH.
  • Regular review of current processes and procedures.Review and implementation of best practices from literature and interactions with peer organizations.
  • In conjunction with the Senior Director of Research Protections, monitor all aspects of CTO operations to ensure institutional compliance with all applicable Federal, State, and Institutional requirements.
  • Design, implement, and monitor the impact of new policies and improved processes.
  • Create and disseminate CTU performance summaries, scorecards, and dashboards to facilitate ongoing quality and performance improvement initiatives
  • Develop Standard Operating Procedures for clinical trial workflow and assist with SOP's for clinical trial management at the disease and modality level, such as subject eligibility and consenting processes.

Regulatory Management

  • Provide leadership and oversight in the monitoring of trial data.
  • Serve as resource for issues related to external audits.
  • Provide training and encourage ongoing educational opportunities to staff.
  • Explore methods to reduce the number of deviations and findings and implement training to ensure compliance with all corrective action plans
  • Oversee the creation and implementation of monitoring checklists.
  • Assist in the development of Fast Track Policy and Procedurewhich includes recommending an IRB of choice for Fast Track; developing criteria to differentiate Fast Track from High Priority and communicating the Fast Track Policy and Procedure to Stakeholders
  • Participate in further streamlining and simplifying the informed consent documentation and guidance
  • Support streamlining and launching all iRIS application forms related to human subject research
  • Participate in revising and launching all action notices for uniformity, standardization across all committees, as well as ensuring only appropriate information is included
  • Support curating all documents associated to active protocols in the regulatory system (iMEDRIS) to ensure they are appropriately categorized and support curating all iRIS reports to eliminate redundant or unused reports
  • Assist in developing the proposal for eRegulatory Binder for leadership's consideration to support more compliant documentation and more efficient documentation/filing so that CRCs and others will have more time to dedicate to OnCore/EPIC implementation

Financial Management

  • Update and maintain all spreadsheets used to plan and track audits by risk level, sponsor, IRB number, and Principal Investigator.
  • Work in collaboration with investigators and Senior Director, Clinical Research Services to define needs, grants and contracts support, protocol billing and compliance needs as well as oversight and development of COH's Medicare coverage analysis centralized service and process.
  • Analyze, document, and improve complex intra-and inter-CTO clinical research financial transactions.
  • Develop budgets and allocate resources among CTO programs and disease and modality teams.
  • Analyze, document and improve complex intra- and inter CTO workflows.
  • Refine the acuity workload assessment tool for CTO personnel
  • Participates in protocol feasibility committee to ensure adequate protocol funding to over research related costs

Technology Management and Development

  • Implement management strategies, quality control methods and tools for providing the highest quality of support and services for our investigators and research staff.
  • Identify, create and implement work plans for all identified EPIC and OnCore process/workflow changes, engaging key stakeholders.
  • Develop SOPs for new processes/workflows that relate to research; communicate changes.
  • Build "ConnectHope" culture through targeted dissemination of capabilities and features of new system.
  • Help ensure change readiness and adoption within COH research enterprise
  • Be the lead operational contact, for the optimization and future developments for the enterprise-wide clinical trial management system, OnCore, as well as EPIC for collaborative development and deployment of ongoing efforts to improve efficiency and reduce duplicative resources.
  • Work collaboratively with investigators to define and improve operational needs for clinical trials staff, identify areas in need of additional resources or reorganization.
  • Oversee and organize procedures for OnCore as well as lead ongoing implementations and interface projects.

Personnel Management

  • Maintain complete responsibility for the day-to-day operations CTO including staffing requirements, training, organization structure, development of staff, support fast growing clinical research and assist with industry-sponsored research growth.
  • Coordinate the implementation of a new infrastructure for management of clinical trials at the City of Hope.
  • Hire, supervise and evaluate clinical research support staff and clinical research administrative support staff to coordinate efficient workflow by utilizing the most effective use of personnel and resources.
  • Work on identifying areas requiring process improvement or compliance, and collaboratively develop solutions.
  • Development and effective implementation of performance metrics and enhance the current acuity score through education and presentation at disease and modality teams
  • Direct supervision of CTO Directors, Regulatory Support Services Director, Multi Center Operations Manager and Monitoring Manager.
  • Participate as a member of the senior leadership team for clinical research operations.
  • Work with direct reports to resolve personnel issues.
  • Attend and participate in departmental staff meetings.
  • Create Job descriptions for existing CTO positions (with assistance from HR).
  • Support CTO staff training, education and development.
  • Recruit and retain high quality staff members.
  • Conduct performance appraisal of directly staff using input from others where applicable.
  • Maintain effective communication with supervisors, program leaders, faculty, managers and staff.
  • Collaborates with nursing leadership to ensure adherence with scope of practicerequirements and support of professional practice framework

Professional Development

  • Enhance knowledge in field.Keep abreast of changes in clinical research best practices.
  • Participate in continuing education courses; attend seminars and forums related to clinical research.
  • Read books, journal articles and government publications.
  • Conduct and host site visits with professional peers to identify best practices and develop a professional network.
  • Participate in institutional benchmarking studies.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Performs other related duties as assigned or requested.

The position directly supervises:

  • Clinical Research Nurse Directors and Managers (4) : Hem/HCT, Medical Oncology, Diabetes and Endocrine
  • Manager of Multi Center Operations
  • Director, Regulatory Support Services
  • Admin support (.5)

Minimum Education and Skills Required for Consideration:

  • Master's degree in Nursing, Business Management, Healthcare Management, or a related discipline.
  • Minimum of seven years of experience related to the management and conduct of oncology clinical trials in an academic setting required. Seven years or more of progressively responsible experience related to auditing, monitoring, or conduct of clinical trials.
  • Minimum of five years of direct management/supervisory experience. Experience in coordinating and managing the efforts of health care personnel who work in the clinical trials arena.
  • Working knowledge of policies and procedures that govern clinical research, including but no limited to FDA regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA).
  • Preferred Courses/Training includeCertified Clinical Research Professional (CCRP), 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.
  • Knowledge of OnCore/EPIC is preferred.

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.

City of Hope is 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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