Executive Director, Community and Quality Clinical Research Operations

About City of Hope

City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope's translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope's specialized cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation's "Best Hospitals" in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.

City of Hope's commitment to Diversity, Equity, and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds, and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds, and perspectives; this is reflected in our work and represented in our people.

Position Summary

To be part of Clinical Research Operations at City of Hope, every employee should understand and share in the COH Vision, support our Mission, and live our Values. These values which include integrity, patient-centered, respect, accountability, and compassion-must guide what we do, as individuals and professionals, every day.

Under the direct supervision of the Vice President of Network Clinical Research Operations, the Executive Director of Community and Quality Clinical Research Operations is responsible for the care delivery, standardization, coordination, and leadership of all clinical trials conducted within the COH community, including the community and affiliate practices (CP) , Orange County (OC) as well as quality clinical research practices management across the department. The Executive Director of Community and Quality Clinical Research Operations (ED CQCRO) is an inspiring leader who provides strategic, operational, and thought leadership to support clinical research and aligns with COH mission and vision to improve the quality of care provided to all of our clinical trial patients and ensures excellence in all we do. The incumbent works collaboratively with the VP of Network Clinical Research Operations and the CTO leadership, clinical department chairs and medical staff to help develop, execute, implement, and monitor best in class clinical research with the highest quality.

The ED CQCRO provides clinical trials operations support both in the community as well as at Duarte and Orange County facilities. The ED CQCRO will also serve as a performance improvement expert and educator in clinical research and education, especially Oncology education. The ED CQCRO coordinates with standard of care nursing peers to ensure high quality research and identify opportunities for performance and quality improvement. The ED CQCRO will oversee the development of on-boarding, training and continuing educational programs using a data-driven focus that sets priorities for improvements aligned to ongoing organizational strategic imperatives. The ED CQCRO will be responsible for ensuring optimal research patient recruitment and management, as well as the standardization of processes and procedures to improve the patient experience for research subjects at the COH owned practices and facilities, including the facility located in Orange County.

This position is directly responsible to ensure all clinical trials, regardless of location, are aligned with COH policies and processes. The person in this position will be the primary point of contact with City of Hope community practices and Orange County sites that supports clinical research. The ED CQCRO clearly delineates roles, responsibilities, and accountabilities for protocol execution in the community and is responsible for initiating training programs as needed to keep the clinical research community abreast of current guidelines and modifications within EPIC and Oncore.

This position will collaborate with the Clinical Trials Office (CTO) to develop processes that benefit the patients which enable seamless transition for timely delivery of care for patients once trials are activated. Inherent in this role, is the need to provide overall education to the clinical research team to accomplish these critical goals.

The ED CQCRO develops and maintains productive relationships with the research and clinical community and other important stakeholders at City of Hope and the community practices outside of Duarte. The Executive Director, also ensures efficient and effective communication between each site and the clinical research infrastructure, support service providers. It is critically important that the Executive Director:

• Relies on experience, expertise and judgment to define and accomplish goals;
• Facilitates communication among leaders and stakeholders at all organizational levels;
• Leads and directs the work of others to oversee the conduct innovative clinical trials and advance the standard of care towards best practices in clinical research; and
• Develops and implements effective performance metrics.

The Executive Director supports high quality research, customer service excellence and fiscal responsibility while serving as a direct link between the clinical research staff and the research operations leadership. The ED CQCRO will present to internal and external groups on study activations, protocols, and other topics as needed.

Key Responsibilities include:

Operational and Goal Setting

• Create standardized functioning and work flows across the community sites and Duarte clinics. Support departmental implementation of new technology and services. Present reports, action plans, and other deliverables.
• Build and sustain relationships with internal and external stakeholders. Work in conjunction with the disease program lead physicians, Principal Investigators, foundation leadership and external sponsors to accomplish goals, projects and research initiatives for assigned protocols.
• Develop and oversee departmental programs and goals that support the strategic plan for the organization and expansion of city of Hope clinical research.
• Review reports submitted by staff members to recommend approval or suggest changes. Effectively communicate (written & oral) across the organization.
• Oversee the implementation of processes to increase accrual across City of Hope.

Personnel Management

• Supervise the recruitment and management of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements. Assign or delegate responsibilities to direct reports.
• Develop, maintain and monitor staffing plans for the community. Collaborate with human resources to provide counseling or performance improvement of staff as needed.
• Ensure all direct and indirect reports are adequately trained to perform assigned duties.
• Responsible for tracking the current status of all required licenses, certifications and any required competencies.
• Measure performance of staff to meet research protocol, regulatory and patient care standards.
• Manage and lead staff to develop collaborative working relationships with other departments as applicable.
• Support & facilitate critical thinking of staff.

Clinical Research Execution

• Ensure positive and effective working relationships within the research community. Establish standards for clinical research activities to assure patient safety, protocol compliance and timely and accurate data collection and alignment with Duarte processes.
• Identify and develop processes and standard operating procedures to support quality research.
• Assure satisfaction of research subjects, investigators, physicians, disease program lead physicians, external sponsors and other customers with the conduct of clinical research.
• Develop and foster collaborative relationships with other departments to support safe and high-quality patient care and services.

Fiscal and Budget

• In partnership with the Vice President of Network Clinical Research Operations and CTO leadership, develop annual budget for assigned areas. Monitor financial reports and variances from budget on a periodic basis.
• Submits required documents for purchasing equipment, supplies and/or for department repairs.
• Identify capital equipment and projects needs on an annual basis. Develops annual staffing plan and submits for approval. Identifies need for modifications to annual staffing plan and submits justification for new positions or changes to staffing plan.
• Identify and communicate opportunities for improved efficiency and/or cost saving within the department. Monitor expenses and supports cost saving programs.
• Collaborate with the Vice President of Network Clinical Research Operations and executive leadership in the development of new programs or services.

Training, Performance, and Quality Control and Improvement

• Develop and implement a training program and process for new clinical research personnel tailored to different levels of experience, both at City of Hope and outside.
• Establish position-based performance metrics for staff. Ensure utilization of metrics to on-going improvement and management of staff.
• Assure regulatory standards are met. Initiate and support quality improvement processes within the department.
• Ensure that City of Hope processes and procedures for identifying potential non-compliance or unanticipated problems are consistent with IRB policies and procedures. Escalate any concerns regarding compliance to appropriate authorities and conduct investigations as required.
• Lead Clinical Research Performance Improvement teams/projects.
• Manage and ensure implementation and effectiveness of performance improvement systems.
• Facilitate the implementation of performance improvement activities that lead to a positive and measurable impact on process and outcome measures.
• Research, design and conduct appropriate on-going clinical research performance and quality training.
• Establish policies, procedures, and standards to meet performance improvement and quality outcomes in a safe, productive and cost-effective manner.
• Establish a continuous performance and quality improvement effort and monitoring and reporting system.
• Identify areas of program strength and improvement, oversee the collection and aggregation of performance improvement data for all clinical research sites, analyze data, define desired outcomes. Develop recommendations that improve patient outcomes and maximize resource utilization.
• Research best performance and quality improvement practices and introduce these concepts to the CTO leadership team to be implemented when and as appropriate.
• Provide regular feedback of the status of performance and quality improvement efforts and impacts to executive leadership, management, and front-line staff.
• Develop innovative programs to address knowledge deficits in quality, regulatory, and performance improvement requirements.
• Partner with departments to evaluate and improve effectiveness of clinical research practices, resource utilization, and relationships.
• Performs other related duties as assigned or requested.

Basic education, experience, and skills required for consideration:

• Master's degree in Nursing or Healthcare Management, or a related discipline or Bachelor's degree in Nursing, the minimum experience requirement plus an additional 2 years of experience.
• Seven to ten years of experience in oncology clinical research with a focus on clinical trials and operations, patient excellence and performance improvement.
• Minimum of ten years of experience related to the management and conduct of oncology clinical trials in an academic setting required.
• 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 not limited to FDA 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 nursing scope of practice.
• Knowledge of clinical care in a clinical research setting.
• Knowledge of quality and performance improvement methodologies, safety and reliability science
• Skilled in communicating effectively, facilitating group processes and training staff; preparing data analysis
• Ability to establish and maintain effective and productive working relationships with all employees, public and private organizations
• Ability to work under pressure and to maintain efficiency and composure
• Demonstrated commitment to participatory management and a strong service orientation
• Exceptional customer service and interpersonal skills
• Proficiency in planning, coordinating and implementing patient and staff safety procedures
• Good judgment and decision-making abilities
• Excellent verbal and written communication skills
• Interest in continuous learning and a commitment to performance improvement
• Talent for leading and facilitating group and team meetings
• Attention to detail and analytical skills
• Ability to work independently within a defined strategy
• Comfortable in handling challenging situations that may involve adverse outcomes
• Ability to work within a matrix organizational structure with many stakeholders

Preferred education, experience, and skills:

• Certified Clinical Research Professional
• Certification in Oncology Nursing
• Current licensure with the California Board of Registered Nursing, or ability to obtain within 2 months of starting position
• Knowledgeable and experienced with Lean, Six Sigma, PDCA and other performance improvement methods, with a record of successful improvement projects.
• Strong record of leadership, project management, and collaboration
• Demonstrated analytic and computer skills including use of statistical control charts with strong writing, problem solving and communication skills

Additional Information:

As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.

• Job Status: Full-Time
• Relocation assistance may apply.

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.