Clinical Research

The mission of the Clinical Research Unit (CRU) is to support Clinical Investigational Research by monitoring patients and administering investigational agents in an outpatient setting. The outpatient area consists of seven private treatment rooms, nine infusion chairs and two exam rooms. In addition to these treatment areas, the CRU also has an area dedicated to blood draw and ECG monitoring. The current hours of operation for the unit are 7 a.m. through 7 p.m. daily and 8 a.m. to 5 p.m. on weekends as necessary. On a daily basis, the unit sees between 30 and 50 patients, and between 19 and 30 investigational treatments ranging from 30 minutes to 12 hours are conducted on the unit. Nursing interventions range from simple blood sampling to complex medication administration. When a protocol requires an overnight stay, the patient is moved to an inpatient bed. Phase I and Phase II trials requiring Investigational treatments in all forms of chemotherapy as well as vaccines are administered in the CRU. The CRU is a self-contained treatment center in which most monitoring tests or procedures are performed on the unit. These include ECGs, Pk blood sampling and physical assessments.

Infusion Registered Nurse

The clinical research infusion nurse facilitates clinical research activity at Moffitt Cancer Center by administering nursing care and protocol-related therapy to patients enrolled on clinical trials. The clinical research infusion nurse will provide direct patient care, perform ongoing assessments, deliver patient education and document in accordance with standards and regulatory guidelines pertaining to specified research patients enrolled onto Moffitt-run clinical trials. As a member of the research team, the clinical research infusion nurse will provide protocol-required therapy and procedures, ensuring protocol compliance and close monitoring while the subjects are on study.

Nurse Practitioners

Nurse practitioners practice medicine within the scope of authority and privileges granted by Moffitt Cancer Center. They provide patient care under the auspices of Moffitt Medical Group, and serve as members of the academic medical enterprise, advancing the institutional mission of contributing to the prevention and cure of cancer.

As a medical provider that is not a physician, but is licensed to diagnose and treat patients under the supervision of a physician, the midlevel assists physicians in the evaluation, management and treatment of patients. The midlevel is involved in a wide spectrum of patients with different medical problems, procedures and co-morbidities. The midlevel works independently within a defined scope of practice and under the authority of supervising physician(s) or by specific protocol(s).

Clinical Trials Office

Clinical Research Nurse Specialist

The mission of the Clinical Trials Office is to support clinical investigators in the development and implementation of clinical studies at the Moffitt Cancer Center by:

• Assisting clinical investigators in screening and enrolling patients for clinical studies
• Providing data management support for clinical studies
• Assisting the principal investigators in the compliant conduct of clinical studies, including assisting in the submission of required regulatory documents, annual reviews, and adverse event reporting
• Providing staff training and education pertaining to clinical studies
• Coordinating and implementing protocol related orders for study patients
• Preparing medical and research records for audits

Research Nurse

The research nurse assists with new patient evaluation, registering eligible patients and coordinating protocol-related care of patients enrolled on clinical studies. The research nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the research nurse/coordinator acts as liaison between the investigators, primary care providers, Cancer Center regulatory staff and the sponsor. Along with the investigator, the research nurse screens, enrolls and follows study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. Research nurses are expected to coordinate the high intensity Phase I, Phase I/II and Phase III trials. Each research nurse coordinates between two and four trials with a total accrual between 30 and 40 patients per year.