Deputy Lead Nurse

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  Supports the Clinical Leads by providing leadership, encouragement, support and positive reinforcement within the clinical team   Deputizes for the Clinical Lead during periods of absence in all aspects of the role including line management  Understands resource (staffing) requirements for assigned studies 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 administering study medication to study participants Familiar with intravenous infusion techniques including pumps Responsible for timely reviewing, recording and following adverse events Responds to medical emergencies in clinic and to adverse events requiring urgent attention 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 Paticipates 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 and performs quality control checks on study source documents for completion, accuracy, and compliance to GCP and protocol Facilitates clinical training and reassessment of core clinical competencies (e.g. venipuncture, cannulation, safety assessments, holter monitoring, etc.) Supports training for both new and existing members of clinical team; assists with new full time and per diem employee training by providing orientation to general study procedures and responsibilities Ensures all members of clinical team are fully trained and signed off in relevant SOP/competency before working unsupervised or on a study Familiarity with crash cart emergency procedures Troubleshooting and problem solving as directed by Clinical Lead Assists with other nursing duties as assigned  The Candidate BSN or RN with at least 6 months experience of working in a clinical research environment or equivalent experience in another role 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, Excel, PowerPoint) High attention to detail   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