Job Abstract

Mission Statement

The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees, and the public.

Summary

The primary purpose of the Sr. Clinical Trial Budget Analyst position is to provide clinical trial budgeting expertise and support to the department of Gastrointestinal Medical Oncology. Ensure thorough preparation of study budgets, negotiation of financially sound contracts, and timely tracking and collection of sponsored payments. Serves as a finance liaison for finance interactions between GIMO, Clinical Research Finance department, the Office of Grants and Contracts, and Legal office, and various industry sponsors. Specifically, this position will have oversight of all industry and federal sponsored clinical trial budgets and contracts (pre-award and post award).

Key Functions

Research Contracts and Budgets

· Works with Principal Investigators, Regulatory Team and Research Nurse Managers to prepare detailed research cost and patient care budgets on new or modified research contracts as required.

· Participates in study initiation meetings to ensure all costs are captured. Educates research staff on financial aspects of study, including which services are standard of care and which are research.

· Develop and approve investigator site and baseline budget.

· Completes Sponsors budget forms.

· Completes CRF budget checklist. Reviews and interacts with CRF regarding coverage analysis data.

· Reviews coverage analysis for accuracy and inclusion into internal departmental trial budget.

· Solicits budgets from participating departments in the clinical trial (e.g., CTRC, QIAC).

· Negotiate with industry sponsors and CROs on new and amended clinical trial budgets. Ensures all research costs are covered, escalates to PI and/or Chair if negotiations reach a standstill.

· Reviews and tracks protocols and protocol amendments for budget items to ensure all points of costs are reflected in the sponsored budget. Update internal budgets as necessary and update Department Finance Team.

· Ensures that department policies and procedures conform to institutional standards as it relates to research patient charges, their budgeting, and their expenditure.

· Creates journal entries for monthly/biweekly startup fee transfers.

· Ensures research charge activity is flowing smoothly for all newly activated studies.

· Conducts research charge reconciliation for all assigned studies.

· Periodically provides updates and departmental training related to research charge billing.

· Liaison with CRF and other institutional authorities regarding research charge billing.

· Develops course data logs and reviews with assigned clinical studies coordinator or research nurse. Assures they are updated timely.

· Collaborate with grant program manager/coordinators on clinical grant development including budgeting of resources and patient care costs for clinical aspects of grant to ensure accurate pre-award submission.

· Processes budget and contract changes for protocol amendments.

· Performs a QA of negotiated budgets in CTMS OnCore to ensure accuracy.

Project Management / Data Analysis / Reporting

· Interacts with all levels of personnel within the department, other institutional departments, as well as outside companies to resolve problems/errors or questions regarding basic accounting reconciliation items.

· Assist with any departmental needs as required, to include special financial and research reports as requested.

· Consults with departmental finance team regarding expense transactions related to each protocol.

· Assists with any OnCore post award budget management queries as required.

Compliance, Education, and Professionalism

· Ensures compliance with Good Clinical Research Practice standards.

· Attends in-services, departmental meetings, mandatory training and/or other events to remain abreast of new policies/procedures affecting the conduct of protocols.

· Serve as a resource for clinical trial budgeting for the department.

· Work closely with members of the regulatory team on assigned studies.

· Crosstrain with members of the existing team on clinical trial budgeting and regulatory submissions.

· Attend other educational and training opportunities as identified, utilizing institutional resources as well as applicable professional societies for the industry.

· Represent department in a pro­fessional and appropriate manner within institution, as well as externally.

· Support and advance the institutional and departmental missions.

· Flexibility and adaptability to change are key components of success in this role.