Division Assignments and roles

Pre-award Team

Dimitra Koutsantoni, Pat Seraphin, Judy Safran (for Molecular Genetics)
Support with:

  • Grant submissions and initiations of clinical trials
  • Just in Time (JIT) submissions (NIH)
  • Negotiation and execution of research/clinical trials agreements
  • Project account set up and chartstring
  • Set up of subawards
  • Research progress reports (RPPRs), IP/patent reports
  • Award modifications/amendments; Subaward modifications/amendments
  • Continuations (competitive and noncompeting)
  • No cost extensions
  • Rebudget approvals
  • Award transfers
  • Close out technical/final invention reports
  • Effort reporting

Clinical Research Support Team 

Fiona Sanders and Kimberley Telesford

  • Review and approval of human subjects research protocols
  • Support with initiation and implementation of externally-sponsored clinical trials, specifically:
    • feasibility questionnaires, pre-study visits, IRB approvals, and compilation of regulatory documentation
    • patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials.
  • Liaison for Pediatric Investigator Networks (linking sponsors with CUMC investigators)
  • Quality Assurance Monitoring for:
    • Sponsor-Investigator Investigational New Drug (IND)/Investigational Device Exemption (IDE) trials
    • Other high risk clinical trials

Post-award Team

Rosario QuinonesArleen Lee, Judy Safran (for Molecular Genetics)

  • Allocation/processing salary distributions
  • Cost transfers
  • Project account monitoring/review of grant expenditures/reconciliations
  • Quarterly attestations
  • Subaward account monitoring
  • Payment of subaward invoices
  • Patient care invoicing
  • Close out of awards and subawards
  • Effort reporting