Background: The Nursing Core was initiated in 1996 with the first trials coming into this Clinical Research Center. From 1996 to 2000 there was one nurse coordinator. At this present time, there are four nurse coordinators, two research coordinators, and two medical technicians.
These professionals have several years of experience in areas such as Cardiology, Urology, Critical Care, Gerontology, Pediatrics and Medical-Surgical Nursing.
Mission: The primary objective of the core is to provide trained research nurse/coordinators to manage each clinical study.
Clinical Trials Manager: Patricia Jackson, BSN
Personnel: Margaret McBride, BSN; Phyllis Martin, LPN; Frances Grant, LPN; Jolita Dorsett, MS; Kenneth Handspike, CMT; Natasha Williams, CMT
The primary responsibility of the research nurse/coordinator is to manage all aspects of the study protocol. The research coordinators 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 act as liaison between the investigators, primary care providers, the institutional review board (IRB), and the funding sponsor. Along with the investigator, the research nurse/coordinator screens, enrolls and follows study subjects, ensuring protocol compliance and close monitoring while the subjects are in the CRC. In addition, the nurse/coordinator is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.
Facilities and Equipment: This core utilizes all areas of the CRC, with the exception of private office space and the analytical lab. The basic equipment used include sphygmomanometers, stethoscopes, thermometers, etc.
Several of the protocols require additional equipment and detailed inservices for the core, such as the HDI pulsewave (external measurement for vascular elasticity), a Doppler ultrasound (monitoring pulses), tilt-table with continuous hemodynamic monitoring and a telemonitor (used to measure hemodynamics of participants via the internet).
Functions: This core facilitates sound conduct of the clinical trial, including:
- Recruitment and screening
- Enrollment and follow-up of eligible subjects
- Maintenance of accurate and complete documentation
- Facilitating informed consent and relevant IRB approvals
- Source documentation
- Maintaining drug dispensing logs, and subject logs
- Managing study-related communications
- Organizational management of all aspects of the trial, including timeliness in completing case report forms
- Data entry
- Reporting adverse drug experiences (ADEs)
Managing caseload and managing study files