Coordinates, directs, and implements the nursing care functions within a research project. Provides direction to assure optimal compliance with research protocols
Additional Summary Specific to Job
SENIOR RESEARCH NURSE
Coordinates and directs one or more aspects of clinical trial research. Including data collection, analysis, or monitoring; case management of protocol participants; recruitment and enrollment of human subjects; protection of subjects and subjects' rights through IRB relations and hospital research department; development of informed consents; preparation of adverse event experience reports; construction and monitoring of case report forms; maintenance of drug accountability records; grant and budget development; report preparation; education of other health-care professionals, patients or families regarding clinical trials, protocol development, program administration; IND, IDE and HDE regulations; creation of data base and data entry; research program audit. Coordinates and administers the nursing care functions within a research project in accordance with research protocols and the daily administration and staff supervision of the project.Conducts physical assessment and educates research participants regarding the overall research objectives and potential benefits and/or risks for participants.Coordinates and maintains contacts with patients, physicians, pharmaceutical companies, and/or other related parties to recruit participants and gain continuing support for the studies. Asists in developing and implementing research protocols, case report forms, regulatory binders and all other research documentation. Collects, logs, and verifies research data; interprets results; produces interim reports, presentations and publications; participates in the writing of scientific papers, reports, manuscripts, and/or grant proposals.Keeps the principle investigator and administrator informed of research and administrative progress through progress reports and other communications on a regular basis. Maintains inventories of investigational drugs and devices, and other research supplies. Identifies problems and trends, recommending procedural changes to the principle investigator and administrator. Directs the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high quality results and adherence to research protocols.Recruits and screens patients, collects specimens as necessary for research project and in accord with research protocols. Enrolls suitable candidates, ensuring all necessary documentation is collected and processed. Provides basic background and education to participants regarding the research project, and potential risks or benefits of participation.Inputs data and maintains research databases and related records needed for research. Schedules follow-up visits and maintains contact with patients, patient's families, department staff, pharmaceutical company representatives, other faculty members and researchers.Distributes research information to faculty, research staff, principle investigator, and others as requested. Oversees all aspects of the clinical trial. Identifies, develops, and maintains suitable site(s) for on-going trial visits.Develops and implements presentations/recruiting initiatives for clinical trials including presenting to potential trial subjects.
Maintains regular communication with clinical sites, investigators, subcontractors, and/or pharmaceutical companies. Interacts with project teams and provide required/necessary training.Interacts with and builds good working relationships with research investigators and staff and with departmental personnel on an ongoing basis.Prepares IRB documents and assists with answering IRB Committee questions, under the guidance of the PI, for final approval. Documents approval of IRB and contract(s).Completes all study forms, study protocols, informed consent and others as needed by agency.Schedules and coordinates pre-site visits, site visits, and coordinates study initiation
Graduation from an accredited nursing program with a minimum of three years related experience. Registered Nurse (State of Texas).
Registered Nurse (State of Texas)
Working knowledge of MS Office.
Effective analytical skills.
Good communication, both verbal and written.
Graduation from an accredited nursing program.
This position requires at least three years of experience in hospital research. The position requires knowledge of hospital and research processes (CPHS) and excellent interpersonal and management skills.
BLS and PALS certification preferred.
Bilingual spanish speaking preferredPHYSICAL REQUIREMENTS:
UT Health Science Center at Houston - 20 months ago