Executive Director of Clinical Trials, Affiliate & Community Practices

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

To be part of 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, urgency, patient-centric focus, respect, accountability, and compassion-must guide what we do, as individuals and professionals, every day.

Under the direct supervision of the Senior Vice President of Research Operations, the Executive Director of the Affiliate & Community Practices (CP) is responsible for the care delivery, standardization, coordination, and leadership of all clinical trials conducted within the COH Community Practices as well as the COH Affiliate Practices. The Executive Director, Affiliate & Community Practices will be responsible for ensuring optimal research patient flow in the community practices utilizing current and future infusion beds/ chairs to minimize the wait times as well as the standardization of processes and procedures to improve the patient experience for research subjects at the COH owned Community Practices.

This position is directly responsible to ensure that the community practice clinical trials are aligned with CCSG requirements to meet the spirit of the guidelines which require that trials are opened to meet the patient needs within the City of Hope designated catchment areas. The person in this position will be the primary point of contact with City of Hope community and affiliate practices which are projected to grow substantially in the next five years. S/he clearly delineates roles, responsibilities and accountabilities for protocol initiation in the community practices and is responsible for initiating training programs as needed to keep the community staff abreast of current guidelines and modifications within EPIC and Oncore.

This position will collaborate with the Clinical Trials Office Leadership on the Duarte campus 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 Executive Director, Affiliate & Community Practices 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, Affiliate & Community Practices also facilitates efficient and effective communication between each site and the clinical research infrastructure / support service providers including the community clinics and affiliate research sites. 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,
• Partners with communication and marketing to advance novel therapies to our patients; 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. S/he 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. Prepare reports, presentations, 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.
• Manage and implement departmental programs and goals that support the strategic plan for the organization and expansion of city of Hope clinical research.
• Prepare reports and metrics for discussion within the clinical integration SPI Research workgroup which will be instrumental in shaping the future course of effective clinical research in the community. Effectively communicate (written & oral) across the organization.
• Identify and implement processes that increase accrual across community practices and affiliates by using EPIC reports to set accrual targets for each study opened at the community practice
• Perform in depth analysis of community practices and affiliates capabilities to enroll on trials and to perform in a sustainable fashion.

Personnel Management

• Recruit and maintain an adequate number 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 plan for community practices and direct and/or coordinate efforts to increase efficiency. Monitor time and effort tracking reports on a periodic basis. Collaborates with human resources to provide counseling or performance improvement of staff as needed.
• Responsible for the orientation and ongoing training and development of staff. Develop and implement ongoing training programs for staff. Responsible for tracking the current status of all required licenses, certifications and any required competencies.
• Manage and lead staff to develop collaborative working relationships with other departments as applicable.

Patient Care and Quality Research

• The person in this position will be the primary point of contact with City of Hope community practices which are projected to grow substantially in the next five years. Must be able to develop and sustain positive and effective working relationships with community practice faculty and regional clinical leaders. Establish standards for clinical research activities to assure patient safety, protocol compliance and timely and accurate data collection.
• Assists in the process of determining which investigator initiated and pharma protocols can move forward operationally within the community practice research hubs Identify and develop processes and standard operating procedures to support quality research.
• 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.
• Assure satisfaction of research subjects, investigators, physicians, disease and modality 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. Assure regulatory standards are met. Initiate and support quality improvement processes within the department.
• Measure performance of staff to meet research protocol, regulatory and patient care standards. Monitor and report results of ongoing quality metrics as appropriate. Support & facilitate critical thinking of staff. Participates in or leads committees and working groups within the institution as required or applicable. Escalate any concerns regarding compliance to appropriate authorities and conduct investigations as required

Fiscal and Budget

• In partnership with the Senior Director of Research Administration, the Senior/Executive Directors develops annual budget for assigned department. 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.
• Identifies and communicates opportunities for improved efficiency and/or cost saving within the department. Monitors expenses and supports cost saving programs.
• Collaborates with the Senior Vice President of Research Operations and executive leadership in the development of new programs or services.

Basic education, experience and skills required for consideration:

• Must have a Bachelor's degree in Business Management, Healthcare Management, or a related discipline.
• Must have a minimum of five years of progressively responsible experience related to auditing, monitoring, or conduct of clinical trials.
• Must have a minimum of five years of experience related to the management and conduct of oncology clinical trials in an academic setting.
• Must have experience in coordinating and managing the efforts of health care personnel who work in the clinical trials arena.
• Must have 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.

Preferred education experience and skills:

• Certified Clinical Research Professional
• Advanced Degree

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.