Summary

The Research Administration Specialist will lead the data collection and reporting efforts of regulatory requirements within the Department of Pediatrics, Research Resource Office (RRO). Primary responsibilities will include using source communication to draft and route critical documents to the regulatory and clinical trial financial groups. The candidate will also contribute to the implementation of pre-award and/or post award activities and programs, including successful cost assessment, research budget development, sponsor billing, vendor payments and account reconciliations.

Job Duties

• Ensures compliance with sponsor, institutional, and federal regulation under IACUC, COI, RCR, FDA, NIH, etc.
• Leads Department efforts in transitioning all hard copy clinical trial regulatory documents into electronic databases.
• Prepares, manages, and updates all clinical trial regulatory requirements in department databases.
• Manages and updates database of credentials and trainings for all faculty and staff involved with the research office.
• Processes and submits clinical trial documents to study personnel for completion: delegation logs, training logs, 1572s.
• Develops and performs audits and compliance reports. 
• Completes cost assessments and study budgets, and enters into the financial module of BCM CTMS. 
• Monitors and maintains clinical trial payments in BCM CTMS. 
• Processes Medicare coverage analysis for qualifying clinical trials through BCM. 
• Reconciles industry sponsored clinical trials including invoicing to sponsors. 
• Communicates with sponsors for outstanding revenue and payments. 
• Develops and prepares clinical trial finance reports for payment activities. 
• Prepares monthly reports using SAP accounting software, CTMS, and other internal databases.
  • Reviews research expenditures to ensure accuracy and appropriateness prior to invoicing sponsor. 
  • Invoices industry sponsors in a timely manner to ensure payment. 
  • Maintains budget section in Clinical Trial Management System (CTMS)
     

Minimum Qualifications

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

Preferred Qualifications

• Bachelor’s degree. No experience required with Bachelor’s degree or Certified Research Administrator certification through the Research Administrators Certification Council (RACC).
• Prior experience working in an academic research setting strongly preferred.
• Familiar, or have existing knowledge, of clinical trial regulatory work, clinical trial financial operations, or grants and contracts administration.
• Able to operate independently with little or minimal guidance in both regulatory and clinical trials finance offices with support from the higher levels of employees.