JOB SUMMARYThe Clinical Research Budget Specialist Senior coordinates and manages multi-site investigator-initiated clinical trials from study startup through activation, ensuring regulatory compliance, operational efficiency, and timely execution. Key responsibilities include facilitating pre-study activities such as CDA submissions, feasibility assessments, CTCA requests, IND/IDE support, and study entry into institutional systems. Oversees PRMC, IRB, and PSR submission processes, resolving delays and coordinating document translation and regulatory requirements. Leads budget development, coverage analysis review, pricing coordination, contract negotiations, and finalization of site and sub-site budgets. Reviews and processes Clinical Trial Agreements (CTAs) and supports study activation by ensuring completion of open-to-accrual requirements. Provides ongoing study status updates, escalates activation barriers, and manages sub-site startup, contracts, monitoring plans, and cross-functional collaboration with stakeholders.
Preferred Qualifications:7+ years of experience in:
o Formal IND submissions
o FDA documentation preparation and follow-up
o Protocol review, revisions, and summary of changes
o Budget development across multiple PIs
o Coverage analysis alignment
o Subsite monitoring plans
o CTS agreements
o eAgreement follow-ups
o NDA execution
o PRMC template updates
o Risk language incorporation into ICF
BENEFITSUT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
- PPO medical plan, available day one at no cost for full-time employee-only coverage
- 100% coverage for preventive healthcare-no copay
- Paid Time Off, available day one
- Retirement Programs through the Teacher Retirement System of Texas (TRS)
- Paid Parental Leave Benefit
- Wellness programs
- Tuition Reimbursement
- Public Service Loan Forgiveness (PSLF) Qualified Employer
- Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATIONRequired- Education
Bachelor's Degree In Business Administration, Health Care Administration, Education/Social Science, or related field
- Experience
7 years Experience in appropriate field and
May consider additional years of experience in lieu of education.
Preferred- Experience
2 years in supervisory capacity
JOB DUTIES- Directs, analyzes, coordinates, and evaluates program operation and procedures.
- Develops and/or oversees development of budget for program.
- Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from program.
- Establishes program goals and objectives and directs program evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals.
- Recommends new policies and procedures for improvement of program activities.
- Plans and coordinates special events. Participates in conferences. Presents data and program information.
- Responsible for design, execution, and effectiveness of system of internal controls, which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable.
- Ensures compliance with applicable laws, regulations, policies, and procedures.
- Coordinates training and development of staff as necessary.
- Reads literature and attends functions to keep abreast of relevant scientific and technical developments related to program.
- Serves on committees as representative of assigned program as appropriate.
- May provide supervision to staff members.
- Performs other duties as assigned.
