Clinical Trials Budget Analyst - Investigational Cancer Therapeutics

About the position

The primary purpose of the Clinical Trial Budget Analyst - Pre-Award position is to develop, process and negotiate industry sponsored contract budgets and amendments, provide accounting/analysis and management of assigned Principal Investigator(s) financial data for budgeting and strategic financial planning. Performs special assignments as required and prepares detailed audit reports, cost reports, etc., for departmental and institutional use.

Responsibilities

• Works with Director, Research Planning & Development to prepare budgets for industry-sponsored clinical trials.
• Prepares and reviews Advance Setup.
• Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI teams and/or Sponsors to resolve these.
• Works with ICT's Regulatory, Budget and PI teams and CRF to review the preliminary and final versions of the Coverage Analysis, accurately reports any discrepancies and incorporates suggestions.
• Complete Advance Set Up requests to establish funding accounts for clinical trials.
• Participates in negotiations with industry sponsors and CRO's to process new and amended clinical trial budgets.
• Analyzes sponsors' budget proposals to determine if the proposed funding is adequate to cover costs associated with trials depending on their complexity, the frequency of patient visits, and the reporting requirements.
• Counters proposals if required and finalizes budgets with the sponsor.
• Ensures a quick turnaround time to complete budgets and activate studies in a timely manner to meet industry standards.
• Creates, updates, and maintains files which include all pertinent correspondence and information regarding pre-award activities for ICT clinical trials.
• Assists in maintaining the ICT Timelines database to ensure all pre-award information is verified and updated in a timely manner to allow the tracking of contract activation timelines.
• Assists in maintaining a database that will provide up-to-date financial information about all department sponsored trial and investigator-initiated funding.
• Ensures compliance with Good Clinical Research Practice standards.
• Attends in-services, departmental meetings, applicable trainings and/or events to remain abreast of new policies and procedures affecting the conduct of protocols.
• Maintains knowledge of clinical trial process.
• Identifies opportunities for process improvement within the Contracts and Budgets team and contributes to the development and implementation of best practices.
• Provides training and support to team members on budget-related processes and procedures.

Requirements

• Demonstrated proficiency in OnCore, ePRTCL, RCTS, MS Excel, and other institutional financial systems.
• Demonstrated thorough working knowledge of institutional and state guidelines, which include purchasing, check requests, petty cash, and travel.
• Ability to practice independently, have strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with patients and co-workers.
• Strong attention to detail.
• Strong organizational skills.
• Ability to work with personal computers using standard word processing software, spreadsheets, and programs for database and graphics usage.
• Demonstrate the ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions.
• May be required to lift up to 15 pounds.
• Requires use of computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc.
• Requires the use of push-button, multiple line telephone set.
• Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
• Be clearly understood by verbal communication in face-to-face encounters and by telephone.

Nice-to-haves

• Master's degree in Business Administration or related business specialty.
• Five or more years experience in accounting or financial data analysis to include one-year supervisory experience.

Benefits

• Relocation Assistance Available