Clinical Research Budget Associate

Clinical Research Budget Associate

The Clinical Research Budget Associate plays a key role in supporting clinical research by developing, analyzing, and negotiating budgets for industry-sponsored and alliance clinical trials. This position provides financial and accounting support for clinical trial programs, contributes to strategic and long-range planning, and ensures that budgets accurately reflect the complexity and operational requirements of oncology studies. The role helps drive efficient financial stewardship, workflow management, and informed business decision-making in a mission-driven environment focused on advancing cancer research and patient care.

Responsibilities

• Provide financial administrative support for clinical research programs, focusing on the development and management of budgets for industry-sponsored clinical trials and alliance studies.
• Collaborate with the Director of Research Planning and Development to prepare detailed budgets for clinical trials, ensuring all trial-related costs are accurately captured.
• Manage and create budgets for all alliances coming into the clinical trials portfolio, aligning funding with protocol requirements and institutional standards.
• Complete Advance Set Up requests to establish funding accounts for clinical trials and ensure accounts are configured correctly for timely study activation and financial tracking.
• Review protocols, amendments, and ancillary documents to identify discrepancies or lack of clarity and work closely with principal investigator teams and sponsors to resolve issues.
• Work collaboratively with regulatory, budget, principal investigator teams, and clinical research finance (CRF) staff to review preliminary and final coverage analyses, report discrepancies, and incorporate recommended changes.
• Assist with strategic and long-range planning for the clinical trials program by attending weekly clinical research review meetings and ad hoc meetings to evaluate new protocols for potential participation.
• Partner with department clinical faculty to support clinical trial goals, providing financial insight and budgetary guidance to help optimize trial feasibility and sustainability.
• Conduct quality assurance reviews on budgets created by pre-award staff to ensure all budgetary items are captured accurately and consistently.
• Train new employees on pre-award budgeting duties and provide ongoing training to existing staff on updates and changes to budget processes implemented by CRF and the institution.
• Assist in maintaining training manuals and documentation for the budget team to ensure processes are clearly defined and up to date.
• Help manage team workload and efficiency by overseeing assignment lists and supporting equitable distribution of tasks.
• Collaborate with the protocol processing team to streamline protocol schema and maximize efficiency of charges and billing workflows.
• Participate in negotiations with industry sponsors and contract research organizations (CROs) to process new and amended clinical trial budgets.
• Analyze sponsor budget proposals to determine whether proposed funding adequately covers trial-related costs, considering trial complexity, visit schedules, and reporting requirements.
• Prepare and present counter proposals when needed, and finalize study budgets and payment terms with sponsors in a timely manner.
• Ensure quick turnaround times for budget completion and study activation to support timely initiation of industry-sponsored trials.
• Create, update, and maintain pre-award files that include all pertinent correspondence and information related to clinical trial budgeting activities.
• Assist in maintaining the timelines database to verify and update pre-award information, enabling accurate tracking of contract activation milestones.
• Support the maintenance of databases that provide up-to-date financial information on department-sponsored trials and investigator-initiated funding.
• Ensure compliance with Good Clinical Research Practice standards in all budgeting and pre-award activities.
• Attend in-services, departmental meetings, trainings, and relevant events to stay current on policies and procedures affecting the conduct and financial management of protocols.
• Maintain a strong working knowledge of the clinical trial process and its financial implications, including budgeting, billing, and coverage analysis.
• Utilize MS Excel, MS Access, Hyperion, OnCore, and other institutional financial systems to support data analysis, reporting, and budget management.
• Use word processing, spreadsheet, database, and graphics software to prepare financial reports, audit reports, cost analyses, and documentation for departmental and institutional use.
• Organize and maintain files and records, including redistributing and updating documentation, which may involve bending, stooping, reaching, walking, extended standing, sitting, and repetitive motions.
• Operate standard office equipment such as computers, facsimile machines, calculators, printers, photocopy machines, and multi-line telephones to perform daily work functions.
• Communicate clearly and professionally in person and by telephone, ensuring that information is conveyed accurately to team members, investigators, and sponsors.
• Demonstrate and promote core values of caring, integrity, and discovery by fostering teamwork and inclusiveness, communicating openly and reliably, modeling safe behaviors, encouraging learning and new ideas, and supporting problem-solving and personal growth.
• Build and maintain effective relationships and networks across clinical, regulatory, financial, and sponsor teams, showing sincere interest in others and their concerns.
• Apply analytical thinking to gather relevant information systematically, break down complex financial and protocol issues into manageable components, and support sound decision-making.
• Approach challenges with curiosity and open-mindedness, offering innovative ideas, solutions, and options to improve budget processes and operational efficiency.
• Perform other related duties as needed to support the financial and operational success of the clinical trials program.

Essential Skills

• Demonstrated proficiency in MS Excel, MS Access, Hyperion, and institutional financial systems used for budgeting, analysis, and reporting.
• Strong understanding of accounting principles, financial management, and data analysis in a healthcare or research setting.
• Thorough working knowledge of institutional and state guidelines related to purchasing, check requests, petty cash, and travel.
• Working knowledge of mainframe access programs and related systems used to monitor cost center or company center activities.
• Ability to work independently, exercise sound judgment, and manage responsibilities with minimal supervision.
• Strong verbal and written communication skills, with the ability to interact effectively with clinical staff, sponsors, and co-workers.
• Excellent attention to detail and accuracy in financial analysis, documentation, and data entry.
• Strong organizational skills, including the ability to manage multiple budgets, timelines, and priorities simultaneously.
• Ability to use personal computers with standard word processing software, spreadsheets, and programs for database and graphics usage.
• Capability to master new software and systems by leveraging available resources such as colleagues, manuals, and training classes.
• Ability to maintain a satisfactory work environment through effective organization of files, records, and documentation.
• Physical ability to perform tasks that may require bending, stooping, reaching, manual handling, walking, visual inspection, extended standing, sitting, repetitive motions, and lifting up to 15 pounds.
• Ability to operate standard office equipment, including computers, facsimile machines, calculators, printers, photocopy machines, and multi-line telephone sets.
• Clear and understandable verbal communication in face-to-face encounters and by telephone.
• Demonstrated analytical thinking skills, including the ability to gather information systematically, break down problems into simple components, and support sound decisions.
• Ability to build and maintain relationships, initiate and develop networks, and show sincere interest in others and their concerns.
• Innovative thinking skills, including approaching problems with curiosity and open-mindedness and offering new ideas, solutions, and options.
• Knowledge of oncology clinical research budgeting, including clinical research budgets, industry trials, and budget development and negotiation activities.
• Experience working with study teams to review protocol documents and communicating with sponsors to finalize study budgets and payment terms.
• Familiarity with OnCore or similar clinical trials management systems used to support financial and operational workflows.

Additional Skills & Qualifications

• Experience in clinical research finance or pre-award budgeting for industry-sponsored trials is highly beneficial.
• Background in oncology or exposure to cancer-related clinical research environments is an advantage.
• Understanding of technology systems used to support financial stewardship, workflow management, operational efficiency, and business decision-making.
• Knowledge of Good Clinical Research Practice standards and their application to budgeting and financial processes.
• Ability to participate effectively in sponsor and CRO negotiations and to advocate for appropriate funding based on trial complexity and requirements.
• Comfort working in a remote, technology-enabled environment and collaborating with distributed teams.
• Interest in contributing to mission-driven work focused on advancing cancer research, patient care, and prevention.
• Commitment to core values of caring, integrity, and discovery, including teamwork, reliability, accountability, safety, responsiveness, and personal leadership.