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
The Clinical Trials Manager (CTM) provides consistent leadership and general oversight of the daily activities of the Portfolio Supervisors and the disease teams s/he support, to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The CTM supports research operations strategic priorities to enhance interdepartmental communication and collaboration and assist in the development of best practices and tools for protocol execution, management and oversight as well as ensure, protocol compliance, quality data collection and compliance with Service Level Agreements (SLAs). The candidate has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements. S/he make decisions independently and oversee important activities relevant to clinical research activities at COH with the support, oversight and supervision of the Senior Director, Clinical Trials Office.
The candidate requires a strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. S/he needs strong leadership skills (scientific and business) and ability to coordinate and lead teams to high performance. The candidate must work to build and maintain relationships with investigators and other external partners and promote COH's reputation. The candidate is accountable for performance and compliance for assigned protocols compliance with ICH/GCP regulations, institutional policies and procedures, quality standards and adverse event reporting requirements internally and externally. The candidate is the point of contact for assigned protocols and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet institutional commitments for assigned protocols. S/he is responsible for quality and compliance in assigned protocols managed under the portfolio supervisors. The CTM is responsible for collaboration with functional outsourced vendors, investigators, other external partners.
It is expected that the CTM will collaborate internally under general direction from the Senior Director of Clinical Trials Office and will be responsible for the independent management of the assigned clinical trials and research projects. The CTM also serves as a subject matter expert and provides training and oversight to the portfolio supervisors to determine the feasibility and value of endorsed clinical trials, and successful management and execution of all aspects of every clinical trial. The Clinical Trials Manager will be responsible for managing the volume of the studies under his/her purview and working with the portfolio supervisor to resource research staff to each study as appropriate.
Further, s/he will assist the Senior Director in the long term planning for the Clinical Trials Office, in addition to the management of the budgets of each of the studies conducted by the trams that s/he supervises. The CTM is expected to work closely with the clinical trials billing team, in addition to other departments, such as Office of Sponsored Research, Office of Shared Resources, the Institutional Review Board, etc.
The Clinical Trials Manager will also be expected to facilitate communications and act as a liaison between the department and outside company sponsors, such as pharmaceutical and biotechnology companies. Additionally, the incumbent will be responsible for overseeing clinical trials or studies involving several different clinical sites. This position requires a high level of expertise and judgment, analysis, and to assist with extensive management demands. Requires independent decision making to prioritize requests and strong organizational skills to develop administrative systems and procedures. Also expected to provide reports on study related financial expenses and income. Ensures that the department is following organizational and federal rules, policies, and regulations regarding clinical researchKey Responsibilities include:
Basic education, experience and certification required for consideration:
- Planning and Goal Setting
- Update and enhance the protocol acuity scoring system.
- Create and implement policies and procedures to ensure work standardization.
- Utilize rounding boards and staff huddles to support Organizational and CTO goals.
- Build and sustain relationships with internal and external stakeholders.
- Support the strategic plan for the organization and for clinical research.
- Support departmental implementation of new technology (OnCore and EPIC) and services.
- Retrieve and deliver pertinent reports to leadership as requested.
- Effectively communicate (written & oral) across the organization.
- Serve on working groups to enable City of Hope to meet its strategic goals.
- Quality Research Oversight
- Responsible for ensuring protocol compliance by staff and providing recommendations for corrective action when necessary.
- Provide back-up support as needed for other CTMs and Portfolio Supervisors.
- Meet regularly with disease program leaders, investigators and CTO Leadership to provide necessary updates.
- Communicate and escalate unresolved issues at the appropriate time to the appropriate level of management.
- Identify and initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work.
- Lead the preparation for external audits in collaboration with Research Quality Monitoring.
- Assist in the review of audited protocols for adherence work with the research team to construct responses to the audit report.
- Meet with internal and external monitors to communicate any issues or challenges and develop corrective action plans as needed.
- Provides input in the development of departmental Policies and Procedures.
- Collaborates with CTO Leadership to lead, manage and document performance improvement projects.
- Develop and manage standard work in identified Subject Matter Expert (SME) area.
- Personnel Management
- Support efforts to recruit and maintain an adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements.
- In collaboration with CTO Leadership, develop, maintain and monitor staffing plan for assigned teams.
- Monitor time and effort tracking reports on a periodic basis and review with Portfolio Supervisor as needed.
- Collaborate with human resources to provide counseling or performance improvement of staff as needed.
- Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable.
- Attends all pertinent departmental COH and Working Group meetings.
- Fiscal and Budget
- Provide financial input for their portfolios in the quarterly and annual budget preparations.
- Collaborate with CTO Leadership to identify disease team needs on a monthly as well as annual basis.
- Develop, manage and report on Disease Team portfolio measures.
- Develops quarterly and annual staffing plan in collaboration with CTO Leadership.
- Identifies and communicates opportunities for improved efficiency and/or cost saving within the department.
- Provide documentation to support the purchase of equipment, supplies and/or for department repairs.
- Provide input and support to CTO and Research Operations Leadership in the development of new programs or services or disease teams.
- Participates in operational and feasibility assessments performed within the disease programs.
- Disease Team Management
- Work in conjunction with the disease team program lead physicians, Principal Investigators, Clinical Research Nurse Managers and CTO Leadership to accomplish goals, projects and research initiatives for assigned disease teams
- Collaborates across multidisciplinary teams
- Provides guidance, direction and management to Portfolio Supervisor regarding disease team meetings (e.g., Protocol Priority List, create agendas, minutes, coordinate speakers, scheduling, etc.)
- Develops corrective action plans (CAPAs) as needed and ensure adherence to them through training and monitoring
- Develops working relationships with study sponsors for future collaborations
- Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Preferred education experience and certification:
- Bachelor's Degree.
- Seven or more years' experience as a Clinical Research Coordinator with 2 or more years supervisory experience.
- CCRP (Certified Clinical Research Professional) certification.
- Master's Degree.
- Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) certification.
- To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.
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.