Executive Director, Clinical Research Operations (Community and Orange County)

About City of Hope

City of Hope is an independent biomedical research and treatment center 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 wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope's exceptional 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

Position Summary

To be part of Clinical Research Operations at City of Hope (COH), 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 Clinical Research Operations and the Physician in Chief, Orange County, the Executive Director of Community and Orange County Clinical Research (ED COCCR) 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 in Orange County (CPOC), and Orange County campus (OC). ED COCCR 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. S/he works collaboratively with the VP of Clinical Research Operations, OC Senior Leadership (Assistant Chief Nursing Office (ACNO), Senior VP of Clinical Operations, and the Physician in Chief) 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 COCCR provides clinical trials operations support both in the community and OC facilities. The ED COCCR coordinates with standard of care nursing peers to ensure high quality research. H/She will oversee and participate in the development of the clinical research portfolio in the community and the OC. The ED COCCR 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 OC.

The person in this position will be the primary point of contact with COH CPOC and OC campus that supports clinical research. They will 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 the various research systems.

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

• 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. They will present to internal and external groups on study activities, protocols, and other topics as needed.

Key responsibilities Include:

Service Excellence:

• Directs and collaborates with the clinical research unit (CRU) nursing leader(s), the charge nurses, infusion nurses, clinical research nurses (CRNs), clinical research physicians and other members of the study management team and ancillary services to ensure safe patient flow, enhancing patient experience by facilitating the right patient, in the right bed or chair, at the right time.
• Shares accountability for safe, effective, high quality care and optimal outcomes in the CRU.
• Ensures the delivery of Patient and Family Centered Care at COH by working with patients and their families based on: Participation, Dignity and Respect, Information Sharing, and Collaboration.
• Serves as a role model and create a great "First Impression" by demonstrating exemplary customer service skills for all customer groups including patients, family/friends, physicians, staff, research study team and support department personnel.
• Identifies and analyzes service excellence trends and ensures staff accountability for adherence to COH Service Excellence standards.

Operational and Goal Setting

• Ensure standardized functioning and workflows across the Enterprise and 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 COH clinical research.
• Effectively communicate (written & oral) across the organization.
• Oversee the implementation of processes at new COH facilities responsible for executing clinical research.

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.
• Accountable for ensuring safe staffing levels and clinical competence to provide excellent nursing care to every clinical trial patient at COH.
• Maintains complete responsibility for staffing requirements, training, organization structure, development of staff, support fast growing clinical research and assist with industry-sponsored research growth.
• Develop, maintain, and monitor staffing plans for the community and OC.
• 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.
• 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.

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 Enterprise alignment.
• 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 VP CRO, OC Leadership and CTO leadership, develop budget(s) 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.

Operational Management

• Oversees the staff in conducting clinical trials according to the protocol and in compliance with internal and external regulatory requirements, applicable Federal, State, and Institutional requirements, and GCP/ICH guidelines.
• Oversees the development, revision and deployment of standard operating policies (SOPs) and works instructions to (1) proactively detect, eliminate and prevent regulatory compliance issues; (2) minimize institutional risk; (3) improve research subject safety; and (4) maximize cost recovery.
• Manages 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.
• Reviews and implements best practices from literature and interactions with peer organizations.
• Participates as a member of the senior leadership team for clinical research operations.
• Serve as a subject matter expert and resource for faculty, staff, and personnel for clinical research related issues.
• Oversees and participates in the implementation of management strategies, quality control methods and tools for providing the highest quality of support and services for our investigators and research staff.
• Leads the optimization and future developments for the enterprise-wide clinical trial management system (CTMS) and Epic for collaborative development and deployment of ongoing efforts to improve efficiency and reduce duplicative resources.
• Works collaboratively with investigators to define and improve operational needs for clinical trials staff, identify areas in need of additional resources or reorganizations.
• Collaborates with the Senior Director of Research Systems for ongoing technological upgrades, implementations, and interface projects.

Basic education, experience and skills required for consideration:

• Must have a Master's degree in Nursing or Healthcare Management completed or in progress, or a related discipline.
  • Candidates currently enrolled in a Master's program must have a completion date within 3 years of employment.
• Must have at least 7 years of progressively responsible experience related to the conduct of clinical trials.
• Must have at least 10 years of experience related to the management and conduct of oncology clinical trials in an academic setting required.
• 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), and The Joint Commission Standards
• Must have knowledge and experience in managing clinical trials.
• Must have knowledge of regulatory guidelines and requirements for the conduct of clinical trials and research subjects protection.
• Must have knowledge and experience in the clinical research environment.
• Must have knowledge and experience in health care setting.
• Must have knowledge broad knowledge of nursing scope of practice.
• Must have knowledge of clinical care in a clinical research setting.
• Must have knowledge of quality and performance improvement methodologies, safety and reliability science
• Must be 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

Required Certification/Licensure:

• Active California Registered Nurse license.
  • If out of state, must obtain CA RN license within 120 days of start date.

Preferred education experience and skills:

• Certified Clinical Research Professional
• Certification in Oncology Nursing
• 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

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.

• Posting Date: May 20, 2021
• Job Field: Clinical Research
• Employee Status: Regular
• Shift: Day Job