Senior Director, Clinical Research Services
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4,000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Under the direct supervision of the Senior Vice President of Research Operations, the Senior Director, Clinical Research Services (CRS) is responsible for the development, implementation, coordination, and leadership (administrative/organizational, regulatory, contractual, coverage analysis and financial) of all interventional trials conducted at City of Hope. The Senior Director, Clinical Research Services will supervise the Clinical Trials Support Services, Clinical Trials Billing Department, EPIC Protocol Content Administrators and the Protocol Development Coordinators. S/he provides key leadership for the clinical research enterprise development and guidance into resource allocation which aligns with national and institutional benchmarks. This position will collaborate with principal investigators and the clinical research team to ensure that all federal/state/local regulatory requirements are followed. S/he drives processes to ensure that institutional operational research objectives are met and that ethical obligations to research care provision are kept.
The Senior Director, Clinical Research Services develops and maintains productive relationships with the research and clinical community at City of Hope. S/he provides oversight to achieve optimal research outcomes and collaborates with strategic planning initiatives focused on increasing clinical research provision. To this end, the Senior Director, Clinical Research Services works closely with the Senior Director of Research Protections, Senior Director of the Clinical Research Unit & Affiliate Practices and Senior Director of Clinical Trials Office in strategically and proactively managing the department, including interpreting compliance requirements, day to day financial planning and annual budget production, on-going assessment and implementation of effective operational processes which support the current technology platforms of EPIC and OnCore.
Essential to this role is to provide management and oversight for all pre and post award activities for the therapeutic clinical trials conducted at City of Hope. S/he oversees a critical department that serves the research community in the negotiation and execution of all clinical trial agreements, Confidentiality Disclosure Agreements, Material Transfer Agreements, Data Use Agreements and other consortium and collaboration agreements and budgeting assessments. The position oversees the coverage analysis and corresponding budget development involving industry, federal, foundation, and internally funded clinical trials. The Senior Director will also provide guidance on the identification of administrative and patient care costs related to clinical trials and will ensure that contract and budget finalization occurs in a timely fashion. In this role, the Senior Director will interact with patient financial billing, general counsel, compliance, COH Medical Foundation, financial services and research operations.
As a leader in research operations, s/he will partner with accounting to lead the financial management of City of Hope's internal, industry, and sponsor-supported clinical trials, including project setup, invoicing, expense allocation, project financial management and project closeout. Creation and implementation of policies, procedures, and internal controls for clinical research financial management is a requirement of this role.
The Senior Director, Clinical Research Services has primary oversight over the EPIC Protocol Content Administrators. S/he will use comprehensive knowledge of therapeutic clinical research studies to develop clear, timely and comprehensive protocol-specific content, (including but not limited to detailed delivery instructions for all required pre-medications, supportive therapy, scans, labs and investigational drugs) for all assigned research studies in support of the EPIC Beacon/Willow build teams. The Senior Director in partnership with the Disease/Modality Team, Study Team and the EPIC Beacon/Willow build teams, will ensure that all research-related content in the EPIC EHR is accurate and up-to-date for both new and ongoing clinical research trials.
In order to support the strategic goal of reducing the activation timeline, the Senior Director, Clinical Research Services oversees the Protocol Development Coordinators. The Protocol Development Coordinator (PDC) is an integral part of cutting edge research at City of Hope. He/she is primarily responsible for assisting researchers with developing, writing and editing investigator-initiated clinical research protocols and clinical trial protocols. Research protocol subject matter is very broad, involving trials studying first-in-man agents, surgical instruments and diagnostic tools, and research studies examining molecular biomarkers, quality of life, and risk factors for disease.
The Senior Director provides guidance and leadership to subordinates and to departmental business 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, evaluation and development of key staff in the units.
Overall Responsibilities include:
- Demonstrated expertise in a variety of fields related to the conduct and management of clinical oncology, HIV/AIDS and Diabetes research.
- Development and effective implementation of performance metrics which drive cost efficiency and optimal results
- Reliance on experience, expertise and judgment to define and accomplish goals.
- Facilitated communication among leaders and stakeholders at all organizational levels
- Lead and direct the work of others to oversee the conduct innovative clinical trials and advance the standard of care towards best practices in clinical research.
Clinical Trials Financial Management
- Leads financial management of City of Hope's internal, industry, and sponsor-supported clinical trials, including project setup, invoicing, expense allocation, project financial management and project closeout.
- Creation and implementation of policies, procedures, and internal controls for clinical research financial management.
- Interacts, establishes cooperative working relationships, and communicates effectively with co-workers and personnel in other departments, particularly Medical Center Clinical Departments, Clinical Trials Support Services, Clinical Trials Office, and Patient Financial Services.
- Create and implement policies, procedures, and internal controls for clinical research financial management.
- Assist with interpretation of policies and procedures, both sponsor and Institutional, as they relate to compliance with laws, Medicare Coverage Analysis, National Coverage Decision, statutes and regulations dealing with clinical trial billing issues.
Clinical Trials Administration / Management
- Overseeing coverage analysis, budgeting, contracting completion in an effective and timely manner.Provide oversight to the department as needed to achieve mandated activation timeline turnaround times.
- Providing exceptional customer service and outreach to the research community in the form of steering committee or working group leadership.
- Oversight over all administrative operations including staff recruitment, on-boarding, performance management, equipment management, purchasing, and space utilization. Adhering to City of Hope's policies, procedures, compliance and practices by all staff.
- Developing and executing strategic vision for clinical trial administration. Analyzing business processes while suggesting and implementing improvements which reduces the activation timeline yet still provides exceptional service.
- Oversees the development, writing and editing non-scientific portions of investigator-initiated clinical research/trial protocol documents. May include their associated materials (letters of intent, consent documents, patient materials, IRB application, etc.).
- Works collaboratively with study team members and regulatory and operational staff, to develop or coordinate the development of the study design and protocol required information. Expands non-scientific areas of the protocol document from limited information and with minimal direct supervision.
- In partnership with and at the behest of the principal investigator, may communicate with pharmaceutical or academic partners to obtain and facilitate operational language. Supervises the review of the entire protocol document for content, consistency, clarity, formatting, and grammar to ensure a submission-ready document.
Epic Content Development
- Supervision of the team dedicated to working collaboratively with physicians, Clinical Research Nurses, Clinical Research Nurse Managers, Clinical Research Coordinators, Investigational Drug Pharmacists and the EPIC (Beacon/Willow) build team in support of clinical research trials conducted at COH.
- In collaboration with the Principal Investigator, Disease and Modality Teams and the study team, will have primary responsibility for the therapeutic clinical research content development of all therapeutic protocols that will guide the Willow and Beacon build as part of the EPIC Electronic Health Record.
- Demonstrated strategic expertise in the coordination and completion of complex order-set builds to support the day-to-day clinical research care operations of the City of Hope.
- Oversee the development of comprehensive protocol-specific content, (including but not limited to detailed delivery instructions for all required pre-medications, supportive therapy, scans, labs and investigational drug) for assigned research studies
- Actively participate in enterprise-wide system improvement initiatives and represent business area in large-scale IT implementations such as EPIC and OnCore.
- Assist with ongoing review of internal processes to streamline or create new more efficient processes; assist in executing process changes and assist with overseeing to completion.
- Analyze and document clinical research business processes in order to develop strong electronic workflow and corresponding system procedural documentation
- 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.
- Interact, establish cooperative working relationships, and communicate effectively with co-workers and personnel in other departments, particularly Patient Financial Services, Regulatory Support Services, Corporate Accounting, Office of Sponsored Research, Clinical Trials Support Services, and Office of Shared Resources.
- Prepare special analyses and reports for the Sr. VP, Research Operations.
- Participate in high level meetings to meet the Strategic goals of Research.
- Represent the organization in various civic, community and professional organizations at the local, state, and national level as required.Establishes working relationships with appropriate organizations and individuals.
- Maintain professional growth and development and keeps abreast of latest trends in area of expertise.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Bachelor's degree, Master's degree preferred.
- Seven years of progressive clinical trial administrative management experience in a large, complex organization.
- Sound financial background in an academic or non-profit setting.
- Experience at a non-profit and/or higher education medical center is required with knowledge of oncology clinical trials.
- Experience with Epic EHR system and OnCore CRMS.
- Strong experience financially managing a large portfolio of industry-sponsored and non-industry sponsored clinical trials.
- Strong knowledge of clinical research, including Medicare coverage analyses and clinical trials budgeting and federal guidelines/regulations pertaining to clinical research.
- Demonstrated knowledge of Electronic Health Records System and Clinical Research Management System.
- Must be detail-oriented with strong problem-solving skills.
- Must have the ability to work closely and effectively with a diverse group of administrators; strong interpersonal and leadership skills; proven ability to effect and influence change through a collaborative and inclusive style.
- Must have a passion for excellent customer service and commitment to exceptional quality.
- Expresses commitment to City of Hope's mission, personally identifies with its vision and takes pride in shared success.
- Exhibits flexibility while influencing others to improve processes and implement changes.
- Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required.
- Excellent written and oral communication.
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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