Vice President, Clinical Research
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.
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 Vice President, Clinical Research is responsible for the implementation, coordination, and executive leadership (administrative/organizational,regulatory, study management, and financial sustainability) of all interventional trials conducted at City of Hope. The Vice President, Clinical Research is accountable for and will provide executive leadership and oversight to the Clinical Trials Office (CTO), the Briskin Center for Clinical Research (BCCR) and the Community and Affiliate Practices (CAP) research operation verticals.
S/he provides proactive executive leadership for the clinical research enterprise coordinating and leading the development of resources to ensure alignment with national/institutional data and regulatory benchmarks and targets. This position will involve a high degree of collaboration with senior operational leaders, principal investigators and the clinical research team(s) to ensure that all federal/state/local regulatory requirements are followed. S/he drives processes and optimizations to ensure that institutional operational clinical research objectives are met and that ethical obligations to research care provision are adhered to.
The Vice President, Clinical Research develops and maintains productive relationships with both the research and clinical community across City of Hope. S/he provides oversight to achieve optimal research outcomes and collaborates with strategic and tactical planning initiatives focused on increasing the provision of clinical research in a timely and cost-effective manner. To this end, the Vice President, Clinical Research works closely with his/her team and the other leaders in research operations in strategically and proactively managing the departments, including interpreting compliance requirements, establishment of operational metrics, day-to-day financial planning and annual budget production, on-going assessment and implementation of effective operational processes which support the current technology platforms (e.g. EPIC, InfoEd and OnCore).
An essential component of this role is to provide management and oversight for the implementation of therapeutic clinical trials conducted at City of Hope on the Duarte campus as well as in the community and affiliate network. S/he oversees the clinical research components within the COH disease and modality teams and the clinical research conducted on the main campus and the COH community practices. This involves the review and/or development of standard operating procedures (SOPs) and guidelines for research studies and will identify and analyze operational opportunities related to research and form
action plans to create an environment of continual improvement.
S/he will drive a culture within the clinical research components at City of Hope to ensure that the community network and academic center work in concert as one cohesive and unified team. The incumbent will oversee clinical research conduct and administration on the Duarte campus and the COH community sites to ensure seamless processes for patient accrual and research data management and will work in partnership with senior enterprise leaders on discovery and clinical innovation, including the potential commercialization of such innovations. S/he serves as a senior level liaison with sponsors, NCI and other funding agencies and is responsible for communication and working with other Cancer Center offices and institutional offices as the point person for clinical research operations. S/he will have responsibility for proactively pursuing a portfolio of investigator-initiated and industry-sponsored research development and grant opportunities and is responsible for overall distribution of workload and development across the disease and modality teams.
The Vice President, Clinical Research provides guidance and leadership to subordinates and to departmental operational personnel to increase the competencies of the organization and to ensure compliance with regulations and internal policies. Responsible for providing leadership in the recruitment, selection, engagement, evaluation and development of key staff in his/her units.
Overall Responsibilities include:
- Demonstrated expertise in a variety of fields related to the study conduct and management of Oncology, HIV/AIDS and Diabetes research.
- Development and effective implementation of performance metrics which drive process and cost efficiency delivering optimal results.
- Reliance on experience, partnership, expertise and judgment to define and accomplish goals.
- Facilitate positive and productive communications among leaders and stakeholders at all organizational levels
- Lead and direct the work of others to oversee the innovative clinical trials and advance the standard of care towards best practices in clinical research.
- May be required to function as the delegate for the SVP of Research Operations as the need presents.
Key Responsibilities include:
Briskin Center for Clinical Research Oversight
- Serve as a role model creating a great First Impression, by demonstrating exemplary customer service for patients, family/friends, physicians, staff, research study teams, and support staff. Support excellence in clinical practice and promote a culture of safe, best-in-class quality care.
- Establish standards for clinical research activities to assure patient safety, protocol compliance, and timely and accurate data collection.
- Oversee a customer service oriented leadership model that supports all faculty in concert with the Briskin Center Medical Director's strategic priorities for developing, composing, and implementing protocols for clinical trials.
- Cleary delineate roles, responsibilities, and accountabilities for protocol initiation. Consistently partner with research leadership team, Senior Director of the Briskin Center for Clinical Research and the Briskin Center Medical Director in order to operationalize pharma and investigator initiated trials.
- Ensure that processes and procedures in place at COH for identifying potential non-compliance are consistent with IRB policies and procedures. Escalate any concerns regarding compliance to appropriate authorities and conduct investigations as required.
- Maintain and further develop productive relationships with all clinical research stakeholders including research patients, as well as physician investigators, disease and modality program leads, COH inpatient and outpatient departments, and external sponsors.
- Further develop and implement a strategic plan to achieve effective and efficient overall coordination and facilitation of clinical protocol activities while providing excellent patient care within the Briskin Center for Clinical Research.
- Collaborate with disease program lead physicians, principal investigators, foundation leadership, external sponsors, cancer center, and research operations leadership to accomplish goals, projects, and research initiatives that support and sustain the growth of clinical research at COH.
Clinical Trials Office Oversight
- Provide oversight regarding the audits of clinical trials for protocol compliance, adverse event reporting, compliance with internal and external regulatory requirements, and GCP/ICH guidelines.
- In collaboration with the Senior Directors of the Clinical Trials Office (CTO), evaluate and optimize clinical research modality / disease research team(s) in terms of, performance, compliance, and resource utilization.
- Working with the Senior Directors within the CTO to proactively detect, eliminate and prevent regulatory compliance issues; minimize institutional risk; improve research subject safety and maximize cost recovery
- Ensure that the CTO processes are well-integrated with the IRB and PRMS processes and
- in partnership with the Executive Director of Research Protections and Senior Directors of the CTO 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.
- Create, present and disseminate CTO performance summaries, scorecards, and dashboards to facilitate ongoing quality and performance improvement initiatives and participate in streamlining and simplifying processes and consent documentation.
- Work in collaboration with investigators and the Senior Director, Clinical Research Services to define budgetary needs required for effective patient care and efficient study and regulatory management.
- Oversee and improve complex intra-and inter-CTO clinical research financial transactions and support the development of budgets to ensure optimal staffing and allocation of resources among the disease and modality programs.
Community /Affiliate Practices Oversight:
- Oversee the care delivery, standardization, coordination, and leadership of all clinical trials conducted within the COH Community Practices as well as the COH Affiliate Practices.
- 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.
- Facilitates efficient and effective communication between each site and the clinical research infrastructure / support service providers including the community clinics and affiliate research sites.
- Create standardized functioning 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. 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.
- Recruit and maintain an adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements
Information Technology Platforms (Epic and OnCore)
- Support the "ConnectHope" culture through targeted dissemination of capabilities and features of new system. Participate in 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.
- In collaboration with the Principal Investigator, Disease and Modality Teams, the Vice President of Clinical Research will have primary oversight of the study team personnel required for the validation of the therapeutic clinical research content of all therapeutic protocols that will guide the Beacon build as part of the EPIC Electronic Health Record and OnCore implementation.
- Serve as the chair of the Clinical Research Integrated Steering Committee and actively participate in enterprise-wide system improvement initiatives and represent business area in large-scale IT implementations and operations such as EPIC and OnCore.
- Assist with ongoing review of internal processes to streamline or create new more efficient clinical research business processes in order to develop strong electronic workflow and corresponding system procedural documentation.
- Providing exceptional customer service and outreach to the research community in the form of steering committee or working group leadership.
- Oversight over all administrative clinical research operations for three critical verticals including staff recruitment, on-boarding, performance management, equipment management, purchasing, and space utilization that support City of Hope's policies, procedures, compliance and practices.
- Creates efficient and flexible processes that foster the submission, review, and execution of research protocols, ensuring that these processes are performed in the least burdensome manner.
- Creates policies and procedures that respects the need to balance the need to conduct innovative research with the need to adhere to external and internal regulations.
- Developing and executing strategic vision for study management that analyze business processes while suggesting and implementing improvements which reduces the activation timeline yet still provides exceptional service.
- Works collaboratively with study team members and regulatory and operational staff, to develop and coordinate the implementation of the protocols across the COH enterprise
- Work with other departments to ensure compliance with sponsor regulations, streamline workflows, and improve processes to improve efficiencies while maintaining an atmosphere that fosters the research mission of the organization.
- Manage other critical day-to-day compliance and operational processes for the clinical research enterprise, including: expense review/approval, patient reimbursements, etc.
- Prepare special analyses and reports for the Sr. VP, Research Operations and participate in high level meetings to meet the Strategic goals of Research.
Basic education, experience and skills required for consideration:
- Must have a Master' Degree
- Must have at least seven years of progressive clinical trial compliance, financial and/or administrative management experience in a large, complex organization.
- Must have strong experience financially managing a large portfolio of industry-sponsored and non-industry sponsored clinical trials.
- Must have a collaborative and inclusive leadership style with proven ability effect and influence and manage change through physicians, PIs and senior management.
- Proficient in team building, conflict resolution, group interaction, and project management.
- Must have Organizational, project management, quality improvement and operational effectiveness skills.
- Must be highly knowledgeable about clinical research in an academic medical environment with specific knowledge and expertise in the areas of current and emerging regulatory issues, grants and contracts from industry, private foundations, and government agencies, the role of sponsors in clinical research, and policy and guideline interpretation, communication, and application.
- Must have a passion for excellent customer service and commitment to exceptional quality.
- Must express commitment to City of Hope's mission, personally identifies with its vision and takes pride in shared success.
- Must exhibit flexibility while influencing others to improve processes and implement changes.
Preferred education experience and skills:
- Advanced graduate degree preferred in clinical, research or pharmaceutical science or related healthcare field.
- Healthcare, medical and/or clinical certifications a strong plus.
- Knowledge of National Cancer Institute Cancer Center Support Grants (NCI CCSG) requirements and City of Hope Comprehensive Cancer Center programs and processes.
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.
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