Job Description Summary
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.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC001332 HCC CTO Administration
Pay Rate Type
Hourly
Pay Grade
University-GEN08
Pay Range
46,206.00 - 62,322.00 - 78,540.000
Scheduled Weekly Hours
40
Work Shift
Job Description
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.
Position Impact
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
Lead the budget development process for all new clinical trials conducted through the Clinical Trials Office.
Key Responsibilities
- 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
Manage the financial review and budget revision process for protocol amendments and ongoing study changes.
Key Responsibilities
- 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
Support contract review processes and study startup activities to facilitate efficient study activation.
Key Responsibilities
- 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
Contribute to departmental initiatives and support the continuous improvement of CTO operations.
Key Responsibilities
- 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
This position regularly collaborates with:
- Principal Investigators (PIs)
- Clinical Research Coordinators
- Clinical Trials Office Leadership
- Office of Research and Sponsored Programs (ORSP)
- Grants and Contracts Accounting
- Ancillary Clinical Departments
- Sponsors and Contract Research Organizations (CROs)