Clinical Research Budget Specialist Senior

Clinical Research Budget Specialist Senior (954477) Job Summary

The 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.

• Facilitate pre‑study activities such as CDA submissions, feasibility assessments, CTCA requests, IND/IDE support, and institutional system entry.
• Oversee PRMC, IRB, and PSR submission processes, resolve delays, and coordinate document translation and regulatory requirements.
• Lead budget development, coverage analysis review, pricing coordination, contract negotiations, and finalization of site and sub‑site budgets.
• Review and process Clinical Trial Agreements (CTAs) and support study activation by ensuring completion of open‑to‑accrual requirements.
• Provide ongoing study status updates, escalates activation barriers, manage sub‑site startup, contracts, monitoring plans, and cross‑functional collaboration.

• 7+ years of experience in formal IND submissions, FDA documentation preparation and follow‑up, protocol review, revisions, and summary of changes.
• Experience in budget development across multiple PIs, coverage analysis alignment, sub‑site monitoring plans, CTS agreements, eAgreement follow‑ups, NDA execution, PRMC template updates, and risk language incorporation into ICF.

• PPO medical plan, available day one at no cost for full‑time employee‑only coverage.
• Paid Time Off, available day one.
• Retirement programs via Teacher Retirement System of Texas (TRS).
• Paid parental leave benefit.
• Wellness programs.
• Tuition reimbursement.
• Public Service Loan Forgiveness (PSLF) qualified employer.

Education
Bachelor's Degree in Business Administration, Health Care Administration, Education/Social Science, or related field.

Experience
7 years of experience in an appropriate field; may consider additional years of experience in lieu of education.

Preferred Experience
2 years in supervisory capacity.

Security
This position is security‑sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal‑opportunity employer, UT Southwestern prohibits unlawful discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.