Research Center Profile:
University of South Florida-Morsani College of Medicine

Center Information

Dawn L. Carnegie
Assistant Director, Operations
Office of Clinical Research
University of South Florida-Morsani College of Medicine
12901 Bruce B. Downs Blvd., MDC28 – Tampa, FL 33612
Tampa, FL 33618
USA
813-974-8558
813-905-9997 (fax)
dcarnegie@health.usf.edu
USF Health Office of Clinical Research
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Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Genetic Disease
Healthy Volunteers
Hematology
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Obstetrics/Gynecology (Women’s Health)
Ophthalmology
Orthopedics/Orthopedic Surgery
Otolaryngology (Ear, Nose, Throat)
Pediatrics/Neonatology
Plastic Surgery
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)
Urology
Vaccines

Center Overview

The University of South Florida (USF) is one of the 40 public research universities nationwide with a very high research activity that is designated as a community engaged institution by the Carnegie Foundation for the Advancement of Teaching. At this institution, research is considered as an ongoing collaboration between faculty, researchers, administrative staff, business and academic partners, and the community.

The USF Health, Office of Clinical Research within the Morsani College of Medicine plays an integral role in facilitating the efficient and effective performance of clinical research studies by using a multi-faceted approach to the provision and support of services vital to the clinical research infrastructure. The OCR operates with a service orientation that addresses the needs of Principal Investigators and other key stakeholders, and builds the research portfolio at USF Health. The staff at the OCR oversees the management of its research studies through a Clinical Trials Management System (CTMS), assists investigators in successful completion of trials, promotes interdisciplinary research and manages awards- from proposal development through financial administration and award closeout. The OCR conducts regular education and training sessions on the requirements and procedures related to the conduct of clinical research and developing new training programs. It also serves as the point of contact for any questions or issues related to clinical trials.

The OCR is further committed to adding new staff and facilities to ensure steady growth of our research office into the future.

Performance Metrics

Regulatory Submission Turn-Around Time: 50 Business Day(s)

Clinical Research Experience

The USF faculty, investigators, and OCR staff at USF Health have extensive experience in conducting clinical trials and evaluating investigational products and devices. We have experience in conducting Phase I through IV sponsor and investigator-initiated trials.

The OCR assists research teams in assuring that research at USF Health sites are:

  • Safe and effective
  • Integrated with clinical operations
  • Compliant with federal and ethical guidelines
  • Fiscally sound and transparent and streamlined, sustainable and responsive to sponsors and patients

The OCR directly communicates with sponsors, CROs and other entities on behalf of the institution, researchers and departments. We continue to develop and implement new programs based on monitoring and assessment to enhance the quality of clinical research at the institution. The OCR has established a close working relationship with the IRBs and ethics committees so that research protocols can be reviewed and implemented in a timely manner. We have the availability of full time coordinators, nurses and regulatory specialist who are expert in conducting trials.

Areas of specialty include:

  • Allergy and Immunology
  • Cardiology
  • Dermatology
  • Endocrinology
  • Gastrointestinal
  • General Internal Medicine
  • Hematology
  • Infectious Diseases
  • Neurology
  • Obstetrics and Gynecology
  • Ophthalmology
  • Otolaryngology
  • Pediatrics
  • Psychiatry
  • Rheumatology
  • Sleep Medicine

Facility Description

The Clinical Research Center (CRC) located at the Morsani Center for Advanced Healthcare is an outpatient facility that provides an infrastructure to assist seasoned and novice investigators in the implementation and conduct of clinical research and trials from Phase I through IV of both drugs and devices. A key attribute of the CRC is that it provides patients and their families with a variety of amenities to encourage retention in clinical research projects. These features include convenient free garage parking adjacent to the clinic building, friendly concierge service upon arrival, private exam rooms for study visits, infusion rooms, Phlebotomy room, investigational pharmacy, on-site nurse manager and free guest wireless internet access. Located in the same building is the diagnostic imaging center to allow patients to move easily from an exam room to receive an MRI, CT scan, mammography, ultrasound, fluoroscopy, bone densitometry, nuclear medicine or basic X-ray.

Investigator Experience

The Morsani College of Medicine is a part of USF Health, which includes College of Public Health, College of Nursing, and Schools of Pharmacy and Physical Therapy so that physicians, nurses, public health workers, researchers and educators can work together to create a community of good health and conduct interdisciplinary research. Research is carried out in Departments, Institutes, Centers and Affiliate partners (Veterans Hospitals and Tampa General Hospital). The University of South Florida-Morsani College of Medicine researchers are well trained and experienced and have a worldwide reputation for excellence in healthcare. Investigator’s expertise ranges across all disciplines of medicine and health. Additional research education and training is available to investigators through the OCR.

Staff Expertise

We conduct multifaceted research with highly skilled and experienced researchers and staff. The OCR provides a dedicated staff of research coordinators, project liaisons, laboratory personnel and regulatory staff to researchers to conduct and manage research studies. The OCR also serves as an educational resource for researchers and staff regarding human subject protection training, good clinical practices and FDA regulations. Our employees have expertise in law, nursing, research compliance, research misconduct, nursing, GCP, HIPAA, regulatory, education, contracts and budgets, and fiscal management.

Patient Demographics

The State of Florida has the highest percentage of its population above the age of 65 of any state in the country and is expected to continue to grow significantly by the years 2015 and 2030. As the baby boomer generation continues to age, a significant pressure is placed upon the healthcare system to provide diagnosis, treatment and prevention therapies. The Tampa Bay area also comprises a unique demographic of a large geriatric population combined with an increase in the growth of adults with 35-55 years of age with a very diverse socioeconomic, racial and ethnic backgrounds. The demographic in Tampa Bay closely matches the national demographic making Tampa a strategically desirable location for sponsors to conduct clinical trials.

Other Information

Our site utilizes the following local and commercial IRBs:

  • USFIRB
  • WIRB
  • Quorum
  • Schulman
  • JCU/ACH

Main email intake: OCR@health.usf.edu

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.