Clinical Research Nurse (Night)

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