The University of Texas System - Houston, TX

posted 4 months ago

Full-time - Mid Level
Remote - Houston, TX
Educational Services

About the position

The primary purpose of the Sr. Clinical Trial Budget Analyst position at The University of Texas MD Anderson Cancer Center is to provide clinical trial budgeting expertise and support specifically to the department of Gastrointestinal Medical Oncology. This role is crucial in ensuring the thorough preparation of study budgets, negotiation of financially sound contracts, and timely tracking and collection of sponsored payments. The analyst will serve as a finance liaison, facilitating interactions between the Gastrointestinal Medical Oncology department, the Clinical Research Finance department, the Office of Grants and Contracts, the Legal office, and various industry sponsors. The position entails oversight of all industry and federal sponsored clinical trial budgets and contracts, both pre-award and post-award. In this role, the analyst will work closely with Principal Investigators, Regulatory Teams, and Research Nurse Managers to prepare detailed research cost and patient care budgets for new or modified research contracts. Participation in study initiation meetings is essential to ensure that all costs are captured accurately. The analyst will also educate research staff on the financial aspects of studies, distinguishing between standard care services and research services. Responsibilities include developing and approving investigator site and baseline budgets, completing sponsor budget forms, and reviewing coverage analysis for accuracy. The analyst will negotiate with industry sponsors and CROs on clinical trial budgets, ensuring that all research costs are covered and escalating issues to the Principal Investigator or Chair when necessary. Additionally, the analyst will be responsible for tracking protocols and protocol amendments for budget items, ensuring that all points of cost are reflected in the sponsored budget. They will also create journal entries for monthly or biweekly startup fee transfers and conduct research charge reconciliations for all assigned studies. The role requires collaboration with grant program managers and coordinators on clinical grant development, including budgeting resources and patient care costs for clinical aspects of grants. The analyst will also process budget and contract changes for protocol amendments and perform quality assurance on negotiated budgets in the Clinical Trial Management System (CTMS) OnCore to ensure accuracy. The position also involves project management, data analysis, and reporting, requiring interaction with personnel at all levels within the department and other institutional departments, as well as outside companies to resolve accounting reconciliation issues. Compliance with Good Clinical Research Practice standards is essential, and the analyst will serve as a resource for clinical trial budgeting within the department. Continuous education and professional development are encouraged, with opportunities to attend training and represent the department in a professional manner. Flexibility and adaptability to change are key components of success in this role.

Responsibilities

  • Prepare detailed research cost and patient care budgets on new or modified research contracts.
  • Participate in study initiation meetings to ensure all costs are captured.
  • Educate research staff on financial aspects of studies, including standard care vs. research services.
  • Develop and approve investigator site and baseline budgets.
  • Complete sponsor budget forms and CRF budget checklist.
  • Review coverage analysis for accuracy and incorporate it into internal departmental trial budgets.
  • Solicit budgets from participating departments in clinical trials.
  • Negotiate with industry sponsors and CROs on clinical trial budgets.
  • Review and track protocols and protocol amendments for budget items.
  • Create journal entries for monthly/biweekly startup fee transfers.
  • Conduct research charge reconciliation for all assigned studies.
  • Provide updates and departmental training related to research charge billing.
  • Liaise with CRF and other institutional authorities regarding research charge billing.
  • Develop course data logs and review with assigned clinical studies coordinator or research nurse.
  • Collaborate with grant program managers on clinical grant development, including budgeting resources and patient care costs.
  • Process budget and contract changes for protocol amendments.
  • Perform quality assurance of negotiated budgets in CTMS OnCore.

Requirements

  • Bachelor's degree in healthcare, business or related field.
  • Three years of clinical research, research administration, business administration or accounting experience, or one year with a preferred degree.

Nice-to-haves

  • Master's degree in healthcare, business or related field.
  • Clinical trial budget experience.

Benefits

  • Relocation assistance available.
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