Summary

The Senior Research Administration Associate will be responsible for managing the financial aspects of clinical research studies operating out of the Department of Pediatrics and Pediatric-Genetics. Key responsibilities will include overseeing internal and external vendor payments, tracking expenses and invoices, invoicing and collecting payments, account reconciliations, reporting on expenses, revenues, and receivables. Additional responsibilities include cost assessment, budget negotiations and development, financial set-up, and resource allocation.

This position will be working with complex clinical trials that involve rare diseases in Pediatrics and Pediatric-Genetics.  The clinical trials involve multiple BCM/TCH collaborators including labs, other departments, TCH Investigational Pharmacy, and Radiology.  The Senior Research Administration Associate works with larger complex studies that are subject to FDA study audits.

This position has a hybrid work arrangement, but may require time in an office setting for trainings, PI and leadership meetings, and related activities.

Employees with CRA certification are eligible for certification pay.

Job Duties

• Manage post-award financial management activities of clinical research studies.
• Responsible for invoicing sponsors, affiliated vendors, and payment tracking.
• Creates and submits invoices for protocol-related items, study visits, pass through cost, patient-related expenses per the completed contract, internal invoices for staff time and effort allocation into study accounts.
• Works with sponsors and clinical teams to resolve inquiries regarding invoices and payments.
• Track all billed invoices, follow up with study sponsors, and enter the payments in the CTMS Finance Module.
• Oversee account status, including all payments and invoices, of all active, pending, and closed RRO clinical trials.
• Prepare monthly reports using SAP accounting software, BRAIN, CTMS and/or contract tracking data.
  • Review research expenditures to ensure accuracy and appropriateness prior to billing sponsor.
  • Invoice industry sponsors in a timely manner to ensure payment.
  • Maintain budget section in Clinical Trial Management System (CTMS) - Generates reports.
• Track all revenue and expenditures related to studies in CTMS.
• Create and maintain with creation and reconciliation of internal/external billing policy, ensuring compliance with applicable federal regulations.
• Assist with developing and maintaining SOP's and procedural guides/guidelines.
• Evaluate and review clinical trials ready for financial closure. Review study progress and perform comprehensive final billing reconciliation.
• Additional duties including pre-award study set up activities such as coverage analysis, cost assessment, budget negotiations and planning.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's degree.  Certified Research Administrator certification through the Research Administrators Certification Council (RACC) may substitute for the degree requirement.
• Four years of relevant experience.

Preferred Qualifications

• Clinical trial billing experience.
• Clinical trial finance, budgeting, and negotiation experience.