Clinical Trials Compliance

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Location: The Clinical Trials Compliance Office is located in the Health Science Center in Gainesville, Medical Science Building-First Floor, Room M113.
 
Phone: 352-273-5946

Fax: 352-273-5960

UF Mail:
Clinical Trials Compliance
PO Box 100215
Gainesville, FL  

Mailing Address:
Clinical Trials Compliance - M113
University of Florida
1600 SW Archer Road
Gainesville, FL.  32610-0215

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Clinical Trials Compliance Team

Yvonne B. Brinson, RN, MHSc, Director - Contact Information

Yvonne launched the new office of Clinical Trials Compliance in December, 2005.  As the Director, she is charged with ensuring that the conduct of clinical trials complies with the laws and regulations that pertain to clinical trial fiscal activities.

Yvonne began her nursing career in 1980, first as a critical care nurse and later as an air ambulance flight nurse. She transitioned to clinical trial research in 1986, as a study coordinator for industry-sponsored studies as well as NIH funded research.  She served as the Project Director for the UF Clinical Center for the Women’s Health Initiative (WHI), which was an NIH funded, $14M, 11-year study of postmenopausal women. Two clinical sites were established, in Gainesville and Jacksonville, and over 4800 study participants were enrolled. Her responsibilities included the overall management of operations, budget, facilities, and personnel for over 36 team members.  She received her Masters in Health Science from NOVA Southeastern University in 2004. Yvonne’s experience in clinical trials provides a broad perspective of the entire research process within the Health Science Center. This perspective includes being knowledgeable about clinical trial needs of multiple departments, clinics and hospitals, as well as keeping up with the overriding state and federal regulations. Yvonne has maintained a working relationship with a variety of research administrative areas throughout the University of Florida. 

Felicia Fitzgerald, Auditor - Contact Information

Felicia joined the Clinical Trials Compliance Office in September, 2006. She is responsible for developing tracking and monitoring procedures for clinical trial fiscal activities and conducting routine compliance reviews to ensure institutional compliance policy and standards are met. 

Felicia began working at the University of Florida in 1999 in the Department of Molecular Genetics and Microbiology.  She then held positions as a Grant Specialist for the UF Shands Cancer Center Clinical Trials Office, and as a Senior Grants Specialist in the Office of Engineering Research, College of Engineering.  She is experienced in creating clinical trials budgets, negotiating with sponsors, handling fiscal activities in People Soft as well as reviewing and paying invoices involving hospital services. She is also experienced in originating new IRB submissions, preparing continuing renewals and managing the closeout of research studies.

Leslie McElvey, BSBA, MS, Document Coordinator - Contact Information

Leslie came to the Clinical Trials Compliance Office in September 2007.  As the Document Coordinator, her job is to ensure that the payment and subject injury language in the study documents is consistent.  This includes reviewing the contract, consent, protocol and other documents and helping draft any revisions needed.

She received her Bachelor of Science in Business Administration in 2000 and a Master of Science in 2002, both from the University of Florida.  Her undergraduate major was Computer Information Science and her graduate work was in Decision Information Science, giving her a complete IT background.  She began her career as a Program Assistant at the UF Shands Cancer Center in the Clinical Trials Office where she worked on regulatory paperwork and served as the IRB Coordinator for several years.  From there, she went to work in Payroll Services at UF as an Administrative Services Coordinator.  After many fulfilling years supervising a great staff that handled employee adjustments and vendor disbursements, she decided to return to clinical trials work.

Idella Philman, Program Assistant - Contact Information

Idella joined the Clinical Trials Compliance Office in December, 2007. She is responsible for the general well being of the office. She manages all of the daily office functions and services including managing the CTC website and coordinating the CTC Information Management Project activities.

Idella began working at the University of Florida in May, 2006 in the department of Molecular Genetics and Microbiology. She has since held a position as secretary for the Associate Dean of Research Development. Her work for the Clinical Trials Office brings proficiency in fiscal operations, maintaining regulatory office needs, and assisting faculty and staff with any Clinical Trial related functions.

Kimberly Snyder, BA, Auditor - Contact Information

Kimberly joined the Clinical Trials Compliance Office in August, 2007. She is responsible for developing tracking and monitoring procedures for clinical trial fiscal activities and conducting routine compliance reviews to ensure institutional compliance policy and standards are met. 

Kimberly received her Bachelors Degree in Interdisciplinary Social Sciences in 1999 from the University of South Florida, and is currently pursuing her Masters Degree in Social Work from Florida State University. In 2001, she began working at the University of Florida Contracts and Grants office. She was responsible for coordinating administration of non-federal contracts and grants awarded to the University of Florida from inception to closure to assure compliance with the terms and conditions of the respective agreements. She was also responsible for federal quarterly reporting and the bi-weekly drawdown of funds from various federal agencies. In 2006, Kimberly was assigned to People Soft reconciliation, where she was responsible for interpreting administrative and fiscal regulations and policies for Contracts and Grants accounting and assisting university administrators and inter-institutional groups in resolving specific administrative/fiscal problems.

Deborah Townsend, MS - Education and Training Coordinator - Contact Information

Deborah joined the Clinical Trials Compliance Office in January, 2008.  She is responsible for organizing clinical trials billing compliance information and presenting it to any investigator and their research teams utilizing clinical services while conducting these trials. She is also available to meet one-on-one with investigators, coordinators, or any other research staff who have questions regarding CTC processes.

Deborah received her Bachelor of Science and Master of Science degrees from UF in 2002 and 2004, respectively.  She began working on child development research as a student at Florida International University in Miami, Florida, and continued that work after transferring to the Department of Psychology at the University of Florida.  She has also gained experience working on clinical trials, grants, IRB submissions, and research billing while employed at the Department of Neurology as a study coordinator, assisting physicians in the Comprehensive Epilepsy Research Program (CERP) from 2004-2007. 

Clinical Trial Compliance Team Reports to:

M. Peter Pevonka, MS, RPh, Senior Associate Dean for Research - Contact Information

Legal Support Provided by the Office of General Council:

Susan B. Collingwood, Senior Associate General Counsel – Contact Information

B. Dianne Farb, Associate University Counsel – Contact Information

Theresa Sanchez, Program Assistant – Contact Information

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CTC Process - Start to Finish, Defining Clinical Trials, Triad of Clinical Trial Documents, Policy & Standards

Overview, First Steps, Medicare Coverage, Budget Building, RAC & DSR - What to Send, Final Steps, Frequently Used Forms & Resources

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