Setting Up Your Award

Rush University research awards come from one of two funding streams: grants (National Institutes of Health and other federal funding awards) or contracts (industry sponsored funding). Your award will be governed by separate divisions of the Office of Research Affairs, depending on its source, and have different requirements under SPA and CRA, as outlined below.

Industry sponsored funding

The Clinical Research Administration process helps you set up your industry-sponsored award through:

1. Contract negotiation of legal terms with the Rush Office of Legal Affairs, including, but not limited to:

  • Confidentiality disclosure agreements
  • Clinical trial agreements
  • Subaward agreements for clinical trials
  • Service agreements for research
  • Registry agreements
  • Data-use agreements
  • Material-transfer agreements
  • Research consulting agreements
  • Amendments

2. Clinical research core support, such as:

  • Clinicaltrials.gov application support
  • Quarterly new-hire training sessions
  • Monthly continuing education sessions
  • Regulatory coordinator support
  • Research nursing support
  • Research coordinator support
  • Synchronization of protocol-related documents prior to contract execution

3. Clinical trial management system (CTMS) support through OnCore, (a relational database used to support key startup activities and subject management within research), including:

  • System training
  • Upgrades, enhancements and troubleshooting
  • Vendor liaisons
  • Reporting

Pre-study activities (Study start process)

Study Start-up for Industry Sponsored Clinical StudiesCRA facilitates key components of this study start-up process (click diagram to enlarge):

  1. Documents from sponsor
  2. Confidentiality disclosure agreement (CDA) processing
    • The Rush Office of Legal Affairs will negotiate your agreement with study sponsors on behalf of the institution and obtain the appropriate signatures.
  3. Submit regulatory documents
  4. IRB review
  5. Coverage analysis
  6. Budget negotiation
  7. Contract negotiation
    • The Office of Legal Affairs will negotiate the legal terms of Contracts with the study sponsor and obtain the appropriate signatures.
  8. Potential research revenue
  9. Synchronization
    • Research Revenue Cycle will complete an internal review of all study documents prior to calendar release to ensure that all documents for research subjects are consistent.
  10. Final budget upload
  11. Final coverage analysis
  12. Contract modification
    • This occurs during Office of Research Affairs synchronization
  13. Signed contract
  14. Calendar release
  15. Open to accrual
  16. Enroll subjects (OnCore)

Contact us

Clinical Research Administration

Linda Bond, MSN, BSN, CNP
Associate Vice President, Clinical Research and Regulatory Operations
Phone: (312) 563-2780
Email: linda_bond@rush.edu

Grant funding (NIH and other federal awards)

Sponsored Programs Administration can help you set up your National Institutes of Health (NIH) or other federally funded award through:

  1. Assistance in interpreting, negotiating and accepting grants
  2. Preparing and negotiating subawards for collaborative research
  3. Requesting activity setup

Contact us

Sponsored Programs Administration

Jennifer Garcia
Director, Sponsored Programs Administration
Phone: (312) 942-3554
Email: jennifer_garcia@rush.edu

Yvonne Harris
Senior Grant and Subaward Specialist
Phone: (312) 563-1990
Email: yvonne_harris@rush.edu

Jennifer Stadler
Grant and Subaward Specialist
Phone: (312) 563-1989
Email: jennifer_a_stadler@rush.edu