DRUG and CLINICAL RESEARCH STAFF
NURSING STAFF: Drug Evaluation Clinic research nurse specialists have an experienced coronary care or intensive care background and are specialized in the area of research.
Research nurse responsibilities include the following: screening for new study patients, patient assessment and teaching, evaluation of study participants for possible adverse effects, and precise and accurate documentation in study case report records. They also have several technical duties such as processing laboratory specimens and computer entry.
Research nurse specialists consult with the patient's physicians(s) and also work closely with hospital nursing staff in maintaining the study protocol requirements. Various educational inservices are conducted in order to keep hospital staff appraised of study protocols.
The nurse coordinator of clinical research section evaluates and coordinates all clinical research studies carried out at the Cardiac Center. He/she supervises personnel with the section and oversees day to day procedures for all investigational and research studies. The coordinator is also responsible for planning and developing potential new research projects as well as maintaining regulatory documents and providing various reports to the pharmaceu- tical company and the Creighton Institutional Review Board in order to comply with FDA regulations.
PHARMACY STAFF: The pharmacy staff includes a chief clinical research pharmacist and a research pharmacy fellow. The chief clinical pharmacist is responsible for overall pharma-ceutical services for the clinical research area. This includes the following: development of potential research projects, serving as a pharmaceutical consultant, and providing various educational programs.
The pharmacist is also involved in drug accountability and drug dispensing. He/she assists the nurses and staff cardiologists in admission to clinical drug studies. In addition, he/she participates in statistical data analysis and the preparation of presentations and publications of drug study data. The research pharmacy fellowship program was designed to train the fellow for successful clinical drug research careers in either the pharmaceutical industry or academia. The fellowship provides knowledge and experience in study design and related clinical drug research methodology, expertise in proper conduct of clinical drug trials, appropriate acquisition of study funding, analysis, presen- tation, and publication of study results, and exposure to ethical legal and regulatory issues in drug research. The fellow also contributes to the education of pharmacy and medical students, internal medicine residents, and cardiology fellows.
BIOSTATISTICAL STAFF: One full-time biostatician is available to aid in study design, data analysis, and in the preparation of results for presentation and/or publication.
Outside departments also have the opportunity to contract for biostatistical services through the Cardiac Center.
RESEARCH SUPPORT STAFF: Three technical research assistants are an important part of the research team. Although their primary goal is to perform data collection and data entry on retrospective studies, they also provide many miscellaneous duties. These include the following: reviewing patient medical records and interviewing patients by phone, assisting nursing staff with scheduling, preparation of study materials, and preparation of study documents for long-term storage.