UNIV - Finance Pre-Award Financial Coordinator - Hollings Cancer Center

UNIV - Finance Pre-Award Financial Coordinator - Hollings Cancer Center

The Finance Pre-Award Financial Coordinator serves as a key member of the Clinical Trials Office (CTO) and is responsible for managing the financial startup and amendment processes for sponsored clinical trials conducted through Hollings Cancer Center. This position collaborates closely with Principal Investigators (PIs), study teams, sponsors, regulatory staff, ancillary departments, the Office of Research and Sponsored Programs (ORSP), and other institutional partners to ensure clinical trials are financially viable, compliant with applicable regulations, and activated efficiently. The coordinator develops and negotiates study budgets, supports research contract workflows, and maintains financial documentation. This position may be eligible for hybrid-remote after an orientation period.

This position plays a critical role in ensuring that sponsored clinical trials are financially sound, compliant with institutional requirements, and activated in a timely manner. Through effective budget development, contract coordination, and stakeholder partnership, the Finance Pre-Award Financial Coordinator supports the successful execution of the Clinical Trials Office research mission.

35% Study Budget Development and Financial Feasibility

• Review research protocols, Clinical Trials Management System (CTMS) clinical study calendars, prospective reimbursement analysis (PRA) information, and sponsor documentation to identify procedures and all study-related costs.
• Revise SPARC system study calendar structure and complete Current Procedural Terminology (CPT) code input.
• Develop comprehensive clinical trial budgets that accurately capture personnel effort, patient care services, ancillary department costs, startup activities, invoicing requirements, and indirect costs.
• Collaborate with investigators, study teams, ancillary departments, and institutional partners to ensure complete budget development.
• Review information provided through feasibility and startup review processes to identify financial concerns that may impact study participation.
• Assess study financial viability and provide recommendations regarding participation when proposed funding does not adequately cover anticipated expenses.
• Negotiate budgets with sponsors and contract research organizations (CROs) to secure appropriate reimbursement.
• Ensure alignment between study protocols, prospective reimbursement analysis, budgets, contracts, informed consent language, and study calendars to support research billing compliance.
• Track budget development milestones within the CTMS and maintain communication with sponsors, investigators, and study teams regarding status and next steps.
• Maintain complete and organized budget documentation in accordance with CTO policies and institutional requirements.

30% Trial Amendment and Budget Maintenance

• Review protocol amendments, revised prospective reimbursement analysis, and updated CTMS clinical study calendars to assess financial impact.
• Analyze amendments to determine necessary updates to study budgets, contracts, and financial tracking systems.
• Develop revised budgets and negotiate additional funding when sponsor-proposed changes increase study costs.
• Collaborate with study teams and investigators to evaluate amendment-related financial implications.
• Ensure budget modifications are incorporated into related contracts, calendars, and study documentation.
• Monitor amendment review timelines to support timely implementation of protocol changes.
• Maintain amendment records and supporting documentation according to CTO standards.

20% Contract and Startup Financial Management

• Prepare and submit study startup and amendment packages through institutional system Cayuse.
• Coordinate contract review activities with ORSP and other institutional stakeholders.
• Monitor contract and startup milestones and communicate status updates to stakeholders.
• Support resolution of budget and contract discrepancies during startup.
• Ensure final internal budget information is consistent across all final documents, including prospective reimbursement analysis, sponsor budget, and informed consent materials.
• Maintain accurate records of contract submissions, negotiations, approvals, and finalized agreements.

15% Team Support, Training, Reporting, and Continuous Improvement

• Participate in startup review meetings, amendment review meetings, staff meetings, investigator office hours, and other operational discussions.
• Provide budget and startup status updates to investigators and leadership as requested.
• Generate and maintain reports related to startup performance metrics and workload management.
• Participate in departmental workgroups, special projects, and strategic initiatives.
• Maintain knowledge of clinical trial regulations, billing compliance requirements, sponsor practices, and institutional policies.
• Attend educational programs and training opportunities to enhance professional development.
• Serve as a resource for study teams regarding budget development and financial startup processes.

Preferred Qualifications

• Experience working in a clinical research environment.
• Clinical trial budget development and negotiation experience.
• Knowledge of sponsored research administration.
• Experience with Medicare Coverage Analysis (MCA) or Prospective Reimbursement Analysis (PRA) processes.
• Knowledge of research billing compliance requirements.
• Experience working with sponsors, CROs, and academic medical centers.
• Experience using CTMS, SPARC, Cayuse, OnCore, or similar research administration systems.
• Advanced Microsoft Excel skills.

Knowledge, Skills, and Abilities

• Strong financial analysis and budgeting skills.
• Ability to interpret complex research protocols and study documents.
• Excellent negotiation and relationship management skills.
• Strong organizational and project management abilities.
• Ability to manage multiple competing priorities in a fast-paced environment.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively with diverse stakeholders.
• Strong problem-solving and critical-thinking abilities.
• High level of accuracy and attention to detail.

Key Stakeholder Relationships

• Principal Investigators (PIs)
• Clinical Research Coordinators
• Regulatory Staff
• Clinical Trials Office Leadership
• Office of Research and Sponsored Programs (ORSP)
• Grants and Contracts Accounting
• Ancillary Clinical Departments
• Sponsors and Contract Research Organizations (CROs)
• Institutional Compliance and Legal Offices

Systems and Technology

• Cayuse
• SPARC
• Clinical Trial Management Systems (CTMS)
• Microsoft Excel
• Microsoft Office Suite
• Institutional financial and reporting systems

Additional Job Description

Minimum Requirements: A high school diploma and three years professional experience in a related area such as accounting, auditing, finance or commercial lending. A bachelor's degree with multiple accounting courses may be substituted for two years of the required work experience.

Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work in confined/cramped spaces. (Infrequent) Ability to bend at the waist. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to fully use both hands/arms. (Continuous) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry up to 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Continuous) Ability to see and recognize objects at a distance. (Continuous) Ability to match or discriminate between colors. (Continuous) Ability to determine distance/relationship between objects; depth perception. (Continuous) Good peripheral vision capabilities. (Continuous) Ability to hear and/or understand conversations. (Continuous) Ability to perform gross motor functions