Research Coordinator III - Child Health Research Institute

University of Florida•Gainesville, FL

1d•$60,000 - $68,000

About The Position

The Department of Pediatrics, Child Health Research Institute, is seeking a Research Coordinator III to perform regulatory compliance and clinical trial administrative activities. The position provides divisional administrative support to the Child Health Research Institute (CHRI) and Powell Gene Therapy Center (PGTC), including handling confidential administrative matters, managing inventories, equipment, facilities, and security measures, processing travel, reconciling PCARDs, and processing reimbursements for PDA-related expenses. The role supports clinical trial research administration by working with study coordinators on study budgets, negotiating budgets and contract terms for industry-sponsored trials, reviewing regulatory compliance packets, coordinating required submissions, and ensuring timely sponsor invoicing and payments. The coordinator monitors progress against timelines and provides updates to the principal investigator and others as appropriate. The position also manages clinical trial regulatory requirements by preparing and submitting documents to internal and external regulatory organizations, maintaining regulatory files, drafting and maintaining standard operating procedures, and monitoring research personnel’s mandatory training.

Requirements

Bachelor’s degree in an appropriate area and three years of relevant experience, or an equivalent combination of education and experience.

Nice To Haves

Experience with clinical trials in an academic research setting.
Regulatory management experience.
Experience drafting and editing SOPs.

Responsibilities

Maintain confidentiality and handle sensitive and non-routine administrative tasks for CHRI and PGTC.
Manage inventories, equipment, facilities, and security measures; participate in special projects and inter-departmental teams.
Process staff travel authorizations, expense reports, bookings, payments, registrations, and related travel items.
Reconcile assigned PCARDs according to institutional and department policy and process PDA-related expense reimbursements.
Work with study coordinators to ensure appropriate study-related expenses are negotiated into budgets.
Negotiate budgets and contract terms for industry-sponsored clinical trials and review trial regulatory compliance packets for completeness and accuracy.
Coordinate submission of applicable materials to the College of Medicine Research and Compliance Office and ensure timely completion and submission of studies.
Submit clinical trial invoices to industry sponsors in a proper and timely manner, in accordance with institutional policies.
Monitor and track program progress against timelines and present updates to the PI and others as appropriate.
Track sponsor invoices and payments in OnCore and my Investigator to ensure payments are received and applied to the appropriate accounts.
Initiate and maintain current clinical trial regulatory files and prepare and submit documents to internal and external organizations as required.
Draft and maintain Standard Operating Procedures.
Monitor and track research personnel’s mandatory training.