Research Coordinator III - Child Health Research Institute
About The Position
The Department of Pediatrics, Child Health Research Institute, is accepting applications to fill the position of Research Coordinator III . The successful incumbent will perform both regulatory compliance and clinical trial administrative activities. Divisional Administrative support for The Child Health Research Institute (CHRI) and the Powell Gene Therapy Center (PGTC): Maintain confidentiality of sensitive information, handles confidential and non-routine administrative tasks, manages inventories, equipment, facilities, and security measures, participates in special projects and inter-departmental teams. Process travel for this program, including creating and processing travel authorizations, expense reports, and all travel related items including booking and paying for flights, lodging, registration, etc. for the CHRI staff. Reconcile PCARDs assigned in accordance with institutional / department policy. Process reimbursements for PDA related expenses. Clinical Trials Research Administration: Work closely with Study Coordinators to ensure that all appropriate study related expenses are negotiated into the budget. Negotiate budgets and contract terms for industry sponsored clinical trials and review study clinical trial regulatory compliance packets for completeness and accuracy. Coordinate the submission of applicable materials to the College of Medicine Research and Compliance Office and ensure that all studies are completed and submitted in a timely manner. Ensure the proper and timely submission of clinical trial invoices to industry sponsors and act in accordance with institutional policies. Monitor and track program progress in relation to developed timelines. Present regular program updates to PI and others as appropriate. Track invoices and payments from study sponsors within OnCore and my Investigator to ensure correct and timely payments are received and applied to the appropriate accounts. Ensure the proper and timely submission of clinical trial invoices to industry sponsors. Clinical Trial Regulatory Management: Initiate and maintain a current regulatory file with preparing and submitting documents related to clinical trials to both internal (UF-IRB, UF-OCR, UF-IBC, etc.) and external (FDA, RAC, WIRB, etc.) organizations as required. Draft and maintain Standard Operating Procedures. Monitor and track 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 of sensitive information
- Handles confidential and non-routine administrative tasks
- Manages inventories, equipment, facilities, and security measures
- Participates in special projects and inter-departmental teams
- Process travel for this program, including creating and processing travel authorizations, expense reports, and all travel related items including booking and paying for flights, lodging, registration, etc. for the CHRI staff
- Reconcile PCARDs assigned in accordance with institutional / department policy
- Process reimbursements for PDA related expenses
- Work closely with Study Coordinators to ensure that all appropriate study related expenses are negotiated into the budget
- Negotiate budgets and contract terms for industry sponsored clinical trials and review study clinical trial regulatory compliance packets for completeness and accuracy
- Coordinate the submission of applicable materials to the College of Medicine Research and Compliance Office and ensure that all studies are completed and submitted in a timely manner
- Ensure the proper and timely submission of clinical trial invoices to industry sponsors and act in accordance with institutional policies
- Monitor and track program progress in relation to developed timelines
- Present regular program updates to PI and others as appropriate
- Track invoices and payments from study sponsors within OnCore and my Investigator to ensure correct and timely payments are received and applied to the appropriate accounts
- Initiate and maintain a current regulatory file with preparing and submitting documents related to clinical trials to both internal (UF-IRB, UF-OCR, UF-IBC, etc.) and external (FDA, RAC, WIRB, etc.) organizations as required
- Draft and maintain Standard Operating Procedures
- Monitor and track research personnel’s mandatory training
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
