Clinical Research Nurse at Nemours in Jacksonville, Florida

Job Description:

The Clinical Research Nurse is responsible for implementing an achondroplasia natural history study by recruiting study participants, obtaining parental permission/assent/informed consent, educating parents/participants, collecting and recording study data, maintaining study records, interfacing with study sponsors, as well as assisting in data analysis and manuscript/abstract preparation.

PRIMARY RESPONSIBILITIES

• Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned;
• Develops source documents, parental permission and assent documents for submission to IRB. Coordinates IRB submissions for assigned studies, maintains regulatory documents during conduct of study; develops and utilizes study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.
• Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
• Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains study databases
• Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.
• Assists in identifying, reporting and following-up on Serious Adverse Events.
• Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
• Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.

• Bachelor's degree required
• RN required
• Research experience preferred
• Effectively uses Microsoft computer software;
• Demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing