Director, Clinical Trials Administration

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.

Position Summary

The Director of Clinical Trials Administration provides expertise and direction over study start-up and financial management processes related to translational and clinical research, serving as a principal advisor to the Senior Director of Clinical Research Services.

General Responsibilities include:

• Providing support and direction to the Clinical Trials Support Services (CTSS) core responsibilities - coverage analysis, budgeting, and contracting to achieve completion in an effective and timely manner.
• Providing support and direction to the Clinical Research Billing (CRB) team in terms of general financial management of City of Hope's clinical trials: sponsor invoicing, charge reconciliation, and institutional recharging.
• Assuming responsibility for CTSS and CRB portions of the study start-up process encompassing the services listed above within City of Hope's Clinical Trials Management System (OnCore).
• Providing exceptional customer service and outreach to the research community in the form of steering committee and/or working group leadership.
• Creating and implementing of policies, procedures, and internal controls.
• Coordinating all administrative operations including staff recruitment, on-boarding, performance management, equipment management, purchasing, and space utilization.
• Ensuring adherence to City of Hope's policies, procedures, compliance and practices by all staff.
• Analyzing business processes while suggesting and implementing improvements.
• Developing and executing strategic vision for clinical trial administration.

This role requires maintaining an effective partnership between Department Chairs and research operations leadership. The range of duties is broad and requires an understanding of the mission and goals of the City of Hope. S/he works closely with research and finance leadership to ensure achievement of financial performance goals as well as the long-term growth objectives of City of Hope's clinical research enterprise. S/he is expected to be an expert within different aspects of clinical research operations with a proven track record of success within the clinical trials/research space while possessing significant managerial experience, preferably in an academic or non-profit space.

Key Responsibilities include:

CTSS Management

• Ensure timely, efficient, and accurate coverage analyses, budgets, and contracts are developed for all clinical trials, as needed, within the overall institutional guidelines and policies.
• Provide direction regarding City of Hope's perspective on coverage analysis development in conjunction with Research Compliance.
• Provide oversight of the day-to-day operations of the CTSS office. Partner with the Senior Director of Clinical Research Services determining the short- and long-term vision for CTSS. Also oversee of the process of building complete and accurate budget estimates for investigator initiated clinical trials.
• Under the supervision of the Senior Director, direct the administrative and financial requirements of the department and ensure success in all activities.
• Provide oversight and ownership of CTSS-based databases, metrics development, and data accuracy.
• Remove roadblocks for tasks that are within the purview of the CTSS office beyond pre-established timelines to ensure quick resolution, and escalation of challenges as needed.
• Work with the Senior Director, Research Protections to confirm alignment across study start-up practices, including IRB approval and ICF development.
• Work with the Director, Clinical Research Content to ensure alignment between finalized budgets / billing grids and Beacon treatment plans in the COH Electronic Health Record (Epic)
• Liaise with Patient Finance to ensure appropriate payment or reimbursement designations are in place based on institutional compliance decisions, nationally recognized guidelines, and/or information from denials management reports

CRB Management

• Lead the financial management of City of Hope's internal, industry, and grant-supported clinical trials, including project setup, invoicing, expense allocation, project financial management and project closeout.
• Manage clinical trial activity under the purview of CTSS and CRB by directing the reconciliation of expenses charged and end-date. Identify annual fiscal needs and make financial recommendations to the Senior Director.
• Keep abreast of COH accounting procedures and directives, and keep the Senior Director informed of the same.
• Interact, establish cooperative working relationships, and communicate effectively with co-workers and personnel in other departments, particularly Medical Center Clinical Departments, Clinical Trials Office, and Patient Financial Services.
• Develop, refine, and advise on practices related to clinical research charge collection in order to maximize expected revenue return.
• Develop monthly disease and modality team financial reports as well as community practice financial reports for dissemination to cancer center, disease/modality team, community practice and research operations leadership.

Clinical Trials Policy Management

• Develop, revise, strategize, and implement policies, procedures, and internal controls for clinical research financial management, coverage analysis, and budget development as they relate to research administration.
• Assist with interpretation of policies and procedures, both sponsor-driven and institutional, as they relate to compliance with laws, Medicare Coverage Analysis, National Coverage Decisions, Local Coverage Decisions, statutes and regulations specific to clinical trials billing.

Information Technology

• Actively participates in enterprise-wide system improvement initiatives and represent business area in large-scale IT implementations such as Epic and OnCore.
• Serve as a subject matter expert with regard to the OnCore CTMS modules specifically related to both CRB and CTSS core responsibilities.
• 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.

General

• Ensure active collaboration between CTSS and CRB to improve budget development practices as it relates to recharges and study sponsor invoicing / payments.
• Work with the Office of General Counsel and the Contract Administrator to assist with the finalization of Master Service Agreements and Clinical Trial Agreements as needed.
• 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.
• Interacts, establish cooperative working relationships, and communicate effectively with co-workers and personnel in other departments, particularly Regulatory Support Services, Corporate Accounting, the Office of Sponsored Research, and the Office of Shared Resources.
• Serve on steering committees and/or working groups as appointed by the Senior Director; participate in high level meetings to meet the strategic goals of research.
• Provide the Senior Director with fund projections and staffing lists for both research and support staff on a regular basis and at fiscal closing.
• Provide and prepare special analyses and regular reports, including department performance metrics, on staffing, resources, internal initiatives, etc. and advise on desirable actions and procedures to Department Chair(s) and senior leadership.
• Liaise with supporting campus units including, but not limited, to Human Resources, Payroll, Office of Sponsored Research, Research Finance, Research Data and Management Analysis, Corporate Accounting, Clinical Trials Office, Subject Protections Committees, Office of Foundation Relations and Facilities and use those contacts to request support and solve problems.
• Represent the organization in various civic, community and professional organizations at the local, state, and national level as required. Establish working relationships with appropriate organizations and individuals.
• Maintain professional growth and development and keeps abreast of latest trends in area of expertise.

Department Management

• Provide 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
• Provide leadership in the recruitment, selection, evaluation and development of key staff in the units.
• Provide training to Principal Investigators, Sponsors, Legal counsel, CRO's, Business Managers, CRA's, and/or Support Staff on COH policies and procedures regarding clinical trial billing processes, as needed.
• Provide timeline / general status updates to Investigators, Study Teams, COH Leadership on a weekly basis or as requested.
• Work with Facilities and Information Technology Services to effectively manage and plan for changing needs in the areas of facilities, computers and other equipment.
• Maintain responsibility for the physical security of department space and maintain relationships with campus units that are responsible for security and safety.
• Advise the Senior Director and leadership on the use of department space and desirable modifications to improve operations.
• Ensure that fiscal year end closing is completed on time and accurately as it pertains to CTSS and CRB.

Personnel Management

• Direct all CTSS / CRB personnel and serve as a management resource for on boarding.
• Manage writing of job descriptions, hiring, layoffs, terminations, evaluations, appointment entry on COH systems, record keeping, and other aspects of personnel management.
• Use COH systems to monitor personnel appointments, payroll, travel claims and other reimbursements, expenditures, transfers of funds and other transactions.
• Direct / supervise staff training, prioritize and assign work to the department staff, and follow up to ensure accurate and timely completion of work.
• Coordinate and delegate staff work and assist staff by answering questions and informing them of COH procedures.
• Hold regular meetings with departmental personnel to discuss administrative issues and issuing of guidelines for internal procedures. Cascade information from the Senior Director or other leadership meetings attended by the Director.
• Review and approve time sheets (via API) for directly supervised staff

Basic education, experience and skills required for consideration:

• Must have a Bachelor's degree in healthcare administration, business, finance, science or related field.
• Must have at least Ten (10) years of current business/research/hospital management experience may substitute for master's education.
• 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 Systems and Clinical Research Management Systems.
• Must have the ability to analyze complex administrative and financial data, create reports and craft effective solutions to both long- and short-term problems.
• 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.
• Demonstrated ability to supervise and motivate professional and administrative support staff, including interviewing, selection, training, performance reviews and disciplinary action.
• Excellent written and oral communication

Preferred education experience and skills:

• Master's degree or MBA/MHA
• Experience at a non-profit and/or higher education medical center.
• Experience with Epic EHR system and OnCore CRMS.

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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