Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery is seeking a Research Administration Specialist to coordinate clinical trials pre- and post-award activities. The Research Administration Specialist will report directly to the Research Administration Manager and will focus on CDAs and CTAs submissions, renewal, monitoring and closeout. This position requires regular interaction with faculty and sponsors delivering high-quality customer service. Excellent communication skills and attention to detail skills are essential, as is adherence to quality standards and all relevant policies and award regulations.

Under the direction of the Research Administration Manager, the Research Administration Specialist plans and executes pre‐award and/or post- award activities including, but not limited to, clinical trials contracts submissions, amendments, renewal and closeout, compliance, and/or financial reporting and tracking for 12 divisions of the Michael E. DeBakey Department of Surgery. Assists the Research Administration Manager in the operational and financial activities of clinical trials management, in addition to assisting principal investigators with administrative guidance pertaining to clinical trial management. Supports the Research Administration Manager on various administrative duties required to reach OSR’s goals and objectives.

This is a hybrid role requiring onsite work two days per week.

Job Duties

• Prepare and maintain reports for all industry-sponsored studies belonging to assigned PIs that show the financial status of each study, including both current revenue and expenses along with anticipated revenue and expenses. 
• Regularly review all invoices for accuracy and ensure that they are paid in a timely manner. 
• Review all sponsored contracts and invoices as appropriate on a routine basis to ensure invoicing occurs as outlined in the sponsored contract. 
• Track payments to ensure they have been received and reflected in the study account as expected. 
• Review hospital billing records, study accounts, and coordinate with study teams to be sure that all invoices listed on the contract are properly invoiced to the sponsor. 
• Prepare clinical trial submissions internally (BRAIN). 
• Submit CDAs, CTAs, NDAs. 
• Contribute to the preparation of budgets for clinical trials for quarterly/biannual/annual reporting purposes. 
• Maintain knowledge of all the relevant billing rules and guidance. 
• Assist with preparing and maintaining standardized research service pricing with affiliated hospitals and clinics. Updates pricing lists as needed. 
• Participate in budget and billing configurations in commercial CTMS, and utilizes CTMS functionality for financial management. 
• Assist with ongoing quality improvement for clinical research financial management. 
• Review accounts and identifies charges billable either to insurance or to the clinical research study.

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Education Preferred: Bachelor’s degree. No experience required with Bachelor’s degree or Certified Research Administrator certification through the Research Administrators Certification Council (RACC).