Clinical Research Nurse - Per Diem

About the Role

Responsible for coordinating, supervising and monitoring study activities, following adverse events and administering study medications. To comply & adhere to GCP guidelines and regulations as required of this role. To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards. To ensure subject safety at all times.

Main Tasks and Responsibilities

• Responsible for administering study medication to study participants
• Familiar with intravenous infusion techniques including pumps
• Responsible for supervising staff and study events on the unit according to protocol requirements
• Responsible for making staff adjustments during absences or others unanticipated work circumstances
• Responsible for monitoring study schedules and reviewing study activities as they progress
• Responsible for reviewing, recording and following adverse events
• Responsible for confirming that a complete screening chart containing informed consents, lab results and Investigator approval is available on the day of admission for every admitted subject
• Responsible for monitoring clinical results, compliance, and/or safety issues which would trigger the exclusion or discontinuation of a participant
• Ability to effectively interact with pharmaceutical company representatives (monitors) and clinical research organizations (CRO) in response to queries during the course of the research study
• Participates in key study meetings – SIV, Clinical Kick-off, paperwork review, dummy run and as required
• Assures that all necessary source documents are available on the unit on a timely basis
• Reviews study source documents for completion
• Familiarity with crash cart emergency procedures. Responds to medical emergencies in clinic and to adverse events requiring urgent attention
• Assists with other nursing duties as assigned

Additional Tasks and Responsibilities

• Assists with new employee (regular and per diem) training by providing orientation to general study procedures and responsibilities

Job Demands

The job may involve the following:

• Very high concentration of work
• Strict and tight deadlines
• Having to juggle a range of tasks/issues simultaneously
• Working in a hazardous environment with high requirement to follow safety procedures
• Working outside normal working hours
• Needing to respond to client demands

Qualifications

• BSN or RN with experience preferably within a critical care setting and/or clinical research environment
• Current/valid Florida nursing license
• Current Advanced Cardiac Life Support (ACLS) certification
• Fluent in English/Spanish preferred
• Computer proficient in Microsoft Office products (e.g. Outlook, Word)
• High attention to details
• Excellent communication and interpersonal skills