Director, Clinical Trial Support Services

The Director of the Clinical Trials Support Services 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 is fully responsible for coverage analysis and corresponding budget development involving industry, federal, foundation, and internally funded clinical trials. The 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 director will assume direct oversight for the coverage analysis process and trials determinations and will interact with patient financial billing, general counsel, compliance, COH Medical Foundation, financial services and research operations.

Responsibilities include:

  • Overseeing coverage analysis, budgeting, contracting completion in an effective and timely manner.
  • Assisting Budget and Contract Administrators 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.
  • Coordinating 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.
  • 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.

Essential Functions:

Programmatic Direction

  • 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.
  • Under the supervision of the Senior Director, direct the administrative and financial requirements of the department and ensure success in all activities.
  • Implement the Senior Director’s instructions and keep the Senior Director apprised of important events.
  • Work with the Senior Director, Research Administration to develop cost centers and assist with budgeting and invoicing questions.
  • Provide regular reports, including performance metrics, on staffing and resources 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 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.

Departmental Management

  • Ensure coverage analyses, budgets, and contracts are developed for all clinical trials, as needed.
  • Manage a timely, effective, and efficient turnaround of the coverage analysis, budgeting, and contracting workload, all-inclusive.
  • Remove roadblocks for tasks that have been within the purview of the CTSS office beyond pre-established timelines to ensure quick resolution, and escalation of challenges as needed.
  • Serve on steering committees or working groups as appointed by the Senior Director.
  • Manage clinical trial activity under the purview of CTSS 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 same.
  • Provide the Senior Director with fund projections and staffing lists for both research and support staff on a regular basis and at fiscal closing.
  • Use COH systems to monitor personnel appointments, payroll, travel claims and other reimbursements, expenditures, transfers of funds and other transactions.
  • Ensure that fiscal year end closing is completed on time and accurately as it pertains to CTSS.
  • Ensure that annual budgets for CTSS are developed accurately, on time, and within the overall institutional guidelines.

Personnel Management

  • Direct all CTSS 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.
  • Supervise staff training, prioritize and assign work to the department staff, and follow up to ensure accurate and timely completion of work.
  • Coordinate 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.

Facilities, IT, and Equipment Management

  • Work with Facilities and Information Technology Services to effectively manage and plan for changing needs in the areas of facilities, computers and other equipment.
  • Responsible for the physical security of department space and maintain liaison 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.
  • Anticipate and plan for changing equipment and facility needs as the department work develops.
  • Serve as principal liaison to campus units for repairs and modifications to offices and utilities including HVAC, phones, data lines and locks.
  • Manage inventoried equipment including preparation of annual inventory reports which includes provision of a yearly listing of all shared equipment within the department.
  • Ensure maintenance contracts are obtained for copiers and other office equipment and that routine maintenance is performed as well as repairs for breakdowns.

Other Responsibilities

  • Work with the Office of General Counsel and the Contract Administrator to negotiate and finalize Master Service Agreements and Clinical Trial Agreements.
  • Liaise with Patient Finance to ensure appropriate payment or reimbursement designations are in place based on Institutional compliance decisions as well as nationally recognized guidelines.
  • Oversee of the process of building complete and accurate clinical trial budgets or the development of relevant budget estimates.
  • 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.
  • Provide timeline / general status updates to Investigators, Study Teams, COH Leadership on a weekly basis or as requested.

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.

Minimum Education and Skills Required for Consideration:

  • Bachelor’s degree in healthcare administration, business, finance, science or related field. Master’s degree or MBA/MHA or equivalent preferred.
  • 5-8 years of healthcare management experience in an academic research or healthcare environment and 5 years of progressively responsible management experience.
  • Demonstrated experience in clinical trial budget development, contracting, coverage analysis drafting, and overall financial management.
  • Excellent interpersonal and organizational skills. High level of integrity and honesty in maintaining confidentiality.
  • Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations, Medicare policy on Routine Costs in Clinical Trials.
  • Demonstrated professionalism and integrity.
  • Demonstrated knowledge of the principles of management and accounting and their use in a research/scientific/medical environment.
  • Ability to analyze complex administrative and financial data, create reports and craft effective solutions to both long- and short-term problems.
  • Demonstrated ability to work independently, set own priorities, recognize problems and follow up to ensure effective action is completed.
  • Excellent oral and written communication skills.
  • Skill in working collaboratively in a team-oriented environment, recognizing others’ expertise and collaborating on final outcomes.
  • Demonstrated ability to supervise and motivate professional and administrative support staff, including interviewing, selection, training, performance reviews and disciplinary action.
  • Strong proficiency in MS Software including, Microsoft Word, Excel, and PowerPoint.
  • Oncore experience a plus.

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.

City of Hope is 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. #LI-LF

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