Experience

University of Florida Jacksonville Physicians, Inc.

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Clinical Research Coordinator

  • Feb 2016 - Present

  • Seek and retain new sources of funding, becoming an integral member of an interdisciplinary team including medical faculty, pharmacists, and nursing staff • Manage site qualification, regulatory start-up, contract and budget negotiation for fourteen studies, including five Phase 3 trials, two Phase 3b trials, three Phase 2 trials, and four Phase 4 studies • Administer operations for above studies within the UF system, including patient care costs, vendor payments, human subject… Show more • Seek and retain new sources of funding, becoming an integral member of an interdisciplinary team including medical faculty, pharmacists, and nursing staff • Manage site qualification, regulatory start-up, contract and budget negotiation for fourteen studies, including five Phase 3 trials, two Phase 3b trials, three Phase 2 trials, and four Phase 4 studies • Administer operations for above studies within the UF system, including patient care costs, vendor payments, human subject payments, payroll, and invoicing sponsors • Manage regulatory aspects of studies in which acting as coordinator, consisting of consenting, ensuring timely data input, staff training, and IRB approval • Operate studies in accordance with ICH GCP, CFR 21, CMS guidelines, and local regulatory and accounting guidelines • Represent principal investigator at investigator meetings and in communication with sponsors, CROs, and collaborators • Mentor and assist with day to day management of one junior level coordinator and one post-doctoral associate/research assistant while consenting subjects, performing data abstraction, and communicating with internal and external sponsors Show less



University of Florida

• United States
• Higher Education
• 700 & Above Employee

• Research Coordinator

  • Sep 2008 - May 2013

  Gainesville, Florida Area •Maintained communication with all project teams and facilitated progress toward project launch, conduct of research, and project close-out •Acted as main liaison for principal investigators in communications with sponsors, including coordination of quarterly site visits and progress reports •Developed and negotiated clinical trial budgets with industry sponsors (ranging from $25K to $1M each) •Reviewed and/or negotiated clinical trial agreements and sub-contracts in collaboration with… Show more •Maintained communication with all project teams and facilitated progress toward project launch, conduct of research, and project close-out •Acted as main liaison for principal investigators in communications with sponsors, including coordination of quarterly site visits and progress reports •Developed and negotiated clinical trial budgets with industry sponsors (ranging from $25K to $1M each) •Reviewed and/or negotiated clinical trial agreements and sub-contracts in collaboration with UF Division of Sponsored Research with special attention to budget, subject cost/injury, intellectual property and potential for clauses related to Federal Acquisition Regulations •Acted as a resource to departmental fiscal staff maintaining post-award budgets (approximately $1M cumulative total) •Completed all research regulatory documents required by local and national ethics and compliance panels and maintained files of same (65 total studies, five clinical trials) •Maintained knowledge of and implemented Code of Federal Regulations for protection of human subjects, Food and Drug Administration policies and procedures for investigational new drugs and devices, and Center for Medicare and Medicaid Services policies related to research subject billing •Monitored all studies for compliance with Health Insurance Portability and Accountability Act (HIPAA) •Assisted investigators with database construction and data mining •Provided leadership to two full-time fellows and a total of eight part-time students conducting regulatory submissions, subject enrollment, and/or medical record review •Completed and submitted competitive grant applications to agencies such as National Institutes of Health •Developed budgets for competitive grant applications (largest in excess of $18M) •Utilized and implemented OMB Circulars A-21 and A-110 when developing pre-award budgets and monitored charges post-award in collaboration with UF Contracts and Grants and departmental staff Show less



University of Florida

• United States
• Higher Education
• 700 & Above Employee

• Graduate Research Assistant

  • Aug 2001 - May 2007

  Department of Pharmacology and Therapeutics Dissertation Title: A Preclinical Study of Flavopiridol in the Treatment of Acute Lymphoblastic Leukemia. Purpose of this project was to study novel agents and new combinations of existing therapies for their potential clinical use in relapsed acute lymphoblastic leukemia (ALL). Skills and techniques utilized: • Cell culture • Modified methyl-thiazol-tetrazolium (MTT) assay to assess cell viability post drug… Show more Department of Pharmacology and Therapeutics Dissertation Title: A Preclinical Study of Flavopiridol in the Treatment of Acute Lymphoblastic Leukemia. Purpose of this project was to study novel agents and new combinations of existing therapies for their potential clinical use in relapsed acute lymphoblastic leukemia (ALL). Skills and techniques utilized: • Cell culture • Modified methyl-thiazol-tetrazolium (MTT) assay to assess cell viability post drug treatment • Sodium dodecyl sulfate-polyacrylimide gel electrophoresis (SDS-PAGE) and subsequent Western blotting • Flow cytometric analysis of Annexin V/Propidium Iodide stained samples for detection of apoptosis and cell cycle kinetics • Direct deoxynucleotidyltransferase dUTP nick end labeling (TUNEL) for confirmation of apoptosis • Median-effect analysis in determination of drug synergy Key Findings: • Determined that cell lines were an adequate disease model for ALL by measuring the sensitivity of six unique cell lines to four agents typically used in the treatment of ALL, and flavopiridol. Established that none of the cell lines expressed p16. • Determined that flavopiridol induces transient G1-S arrest and modest apoptosis at low clinically achievable concentrations and sustained G1-S and G2-M arrest and substantial apoptosis at higher clinically achievable concentrations. • Established that flavopiridol treatment decreases the phosphorylation of retinoblastoma protein on specific serine residues; an indication of a reduction in endogenous cyclin dependent kinase activity. • Showed that there is not a substantial difference in flavopiridol activity in the presence of human serum when compared to fetal bovine serum and that primary ALL cells are sensitive to flavopiridol. • Determined that combining flavopiridol with paclitaxel resulted in a greater effect than single agent treatment. Show less



St. Vincent's HealthCare

• United States
• Hospitals and Health Care
• 400 - 500 Employee

• Medical Technologist

  • Jan 2001 - Jul 2001

  Jacksonville, Florida Area • Acted as a “float” between the departments of Clinical Chemistry and Microbiology assuring the proper accession, processing, testing and reporting of results from clinical specimens collected from inpatients or outpatients visiting an affiliated clinic in the five county greater Jacksonville area. • Utilized automated specimen handling equipment, multiple chemistry analyzers, STAT lab testing, ova and parasite exams, and urinalysis.