Senior Director, Clinical Research Services

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

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, budgetary, 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 team, the Clinical Trials Billing department, and the Clinical Research Content department (comprised of Protocol Content Administrators, Oncore Calendar Builders, and eCRF Developers). S/he provides key leadership for clinical research enterprise development and guidance into resource allocation which aligns with national and institutional benchmarks. This position will collaborate with principal investigators and clinical research teams 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 staff to develop 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, the Senior Director of the Clinical Research Unit, the Senior Director of the Community & Affiliate Practices, the Senior Director, Research Applications & Data Management, and the Senior Director of the 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 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. The position oversees the coverage analysis and corresponding budget development processes involving industry, federal, foundation, and internally funded clinical trials. The Senior Director will also provide guidance on the identification of operational and patient care costs related to clinical trials and will ensure that budget assessments or contract / budget finalization occurs in a timely fashion. In this role, the Senior Director will typically interact with accounting, general counsel, compliance, COH Medical Foundation, Patient Financial Services, and other shared services teams.

As a leader in research operations, s/he will partner with accounting and revenue cycles teams to lead the financial management of City of Hope's internal, industry, and sponsor-supported clinical trials, including project setup and budget development, invoicing, expense allocation, project financial management, charge segregation and project closeout. The Senior Director will also partner with research compliance leadership as it pertains to co-mingled responsibilities around coverage analysis development, charge allocation, and charge segregation activities. 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 also has oversight over the Protocol Content Administrators via the Director of Clinical Research Content. S/he will use comprehensive knowledge of therapeutic clinical research studies to assist the team in developing 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 Disease/Modality Teams, Study Teams, and Epic Beacon/Willow build teams, will ensure that all research-related content in the Epic Electronic Health Record is accurate and up-to-date for both new and amended clinical research trials.

S/he will also partner with the Director of Electronic Case Report Form (eCRF) Administration and provide oversight to the development team. The Senior Director will be tasked with managing the complexities and intricacies of form creation as it pertains to locally based clinical research projects. S/he will use industry expertise to assist in the determination of form development costs, staff budgeting, and database maintenance for the research community utilizing this shared service. S/he will also partner with related leadership as it pertains to the OnCore CTMS and the Research Applications & Data Management team in order to develop best practices and SOPs related to the eCRF process at COH.

Finally, this position has responsibility in the oversight of the OnCore calendar builder team. S/he works extensively with clinical research coordinators, principal investigators, and various stakeholders at City of Hope to assist with building calendars in accordance with clinical research protocols / budgets within the OnCore Clinical Trials Management System (CTMS). This position will be responsible for the ongoing oversight of the OnCore calendar building team to increase the competencies of the organization and to ensure compliance with regulations and internal policies. The position is also responsible for providing leadership in the recruitment, selection, evaluation, and development of key staff related to this process.

Key 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
• Leadership and direction as it relates to the work of others, specific to the conduct of innovative clinical trials, and advancement in best practices standards within the clinical research space.

Clinical Trials Financial Management

• Leads financial management of COH's internal, industry, and sponsor-supported clinical trials, including project setup, invoicing, expense allocation, project financial management, charge segregation 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.
• Creates and implement policies, procedures, and internal controls for clinical research financial management.
• Assists with interpretation of policies and procedures, both sponsor and institutional, as they relate to clinical research billing compliance, Coverage Analysis, National / Local Coverage Decisions, statutes and regulations dealing with clinical trial billing issues.

Clinical Trials Administration / Management

• Oversees coverage analysis, budgeting, contracting processes in an effective and timely manner. Provides oversight to the clinical and operations departments as needed to achieve mandated activation timeline turnaround times.
• Provides 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. Adheres to City of Hope's policies, procedures, compliance, and practices by all staff.
• Develops and executes strategic vision for clinical trial administration. Analyzes business processes while suggesting and implementing improvements which reduces the activation timeline yet still provides exceptional service.
• As needed, works collaboratively with study team members and regulatory and operational staff, to develop or coordinate the development of study design and protocol required information.
• In partnership with, and at the behest of the principal investigator, communicates 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.

Protocol Content Development

• Provides general oversight of the team dedicated to working collaboratively with physicians, Clinical Research Nurses, Clinical Research Nurse Managers, Clinical Research Coordinators, Investigational Drug Pharmacists and Epic(Beacon/Willow) build teams in support of clinical research trials conducted at COH.
• In collaboration with the Principal Investigator, Disease and Modality Teams, and study teams, responsibility over the therapeutic clinical research content development of all therapeutic protocols that guide Willow and Beacon builds 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.
• Oversees 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 drugs) for assigned research studies.

OnCore Calendar Builders

• Oversees the build and configuration of electronic study calendars with budget details for clinical trial data capture in accordance with the terms of the protocol.
• Supervises the process by which the OnCore protocol information, both new studies and amendments, adheres to the actual clinical trial protocol calendar and external budget documents.
• Develops prioritization schema to aid in workload management for calendar and budget build tasks.
• Performs system testing as directed and quality control of application functionality during application upgrades.
• Partners with Information Technology teams to support COH stakeholders and users who encounter problems or have questions.
• Collaborates with direct supervisor, finance teams, clinical research teams, project managers, consultants and vendors to ensure overall completion of goals, schedules, and deadlines.

Information Technology

• Actively participates in enterprise-wide system improvement initiatives and represent business area in large-scale IT implementations such as Epic and OnCore.
• Assists with ongoing review of internal processes to streamline or create new more efficient processes; assists in executing process changes and assist with overseeing to completion.
• Analyzes and documents clinical research business processes in order to develop strong electronic workflow and corresponding system procedural documentation.

Management / Leadership

• Works with other departments to ensure compliance with sponsor and research regulations, streamline workflows, and improve processes and general efficiencies while maintaining an atmosphere that fosters the research mission of the organization.
• Manages other critical day-to-day compliance and operational processes for the clinical research enterprise, including: expense review/approval, patient reimbursement decisions, etc.
• Interacts, establishes cooperative working relationships, and communicates 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.
• Prepares special analyses and reports for the Sr. VP, Research Operations.
• Participates in high level meetings to meet the strategic goals of research.
• Represents 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.
• Maintains 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, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
• Performs other related duties as assigned or requested.

Basic education, experience and skills required for consideration:

• Must have Bachelor's degree
• Must have seven years of progressive clinical trial administrative management experience in a large, complex organization.
• Must have sound financial background in an academic or non-profit setting.
• Must have experience at a non-profit and/or higher education medical center is required with knowledge of oncology clinical trials.
• Must have experience with Epic EHR system and OnCore CTMS.
• Must have strong experience financially managing a large portfolio of industry-sponsored and non-industry sponsored clinical trials.
• Must have strong knowledge of clinical research, including Medicare coverage analyses and clinical trials budgeting and federal guidelines/regulations pertaining to clinical research.
• Must have demonstrated knowledge of Electronic Health Records System(s) and Clinical Trial Management System(s).
• 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.
• 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.
• Must anticipate needs, responds quickly, provides guidance and support, monitors and follows up as required.
• Must have excellent written and oral communication.

Preferred education experience and skills:

• Master's 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.