Deputy Lead Nurse

Quotient Sciences•Miami, FL

About The Position

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 roleTo ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standardsTo 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 studiesResponsible for supervising staff and study events on the unit according to protocol requirements. Responsible for making staff adjustments during absences or others unanticipated work circumstancesResponsible for monitoring study schedules and reviewing study activities as they progressResponsible for administering study medication to study participantsFamiliar with intravenous infusion techniques including pumpsResponsible for timely reviewing, recording and following adverse eventsResponds to medical emergencies in clinic and to adverse events requiring urgent attentionResponsible 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 subjectResponsible 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 studyPaticipates 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 basisReviews and performs quality control checks on study source documents for completion, accuracy, and compliance to GCP and protocolFacilitates 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 responsibilitiesEnsures all members of clinical team are fully trained and signed off in relevant SOP/competency before working unsupervised or on a studyFamiliarity with crash cart emergency proceduresTroubleshooting and problem solving as directed by Clinical LeadAssists 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 roleCurrent/valid Florida nursing licenseCurrent Advanced Cardiac Life Support (ACLS) certification Fluent in English/Spanish preferredComputer proficient in Microsoft Office products (e.g. Outlook, Word, Excel, PowerPoint)High attention to detail Excellent communication and interpersonal skills Job DemandsThe job may involve the following: Very high concentration of workStrict and tight deadlinesHaving to juggle a range of tasks/issues simultaneouslyWorking in a hazardous environment with high requirement to follow safety proceduresWorking outside normal working hoursNeeding to respond to client demands

Requirements

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
Computer proficient in Microsoft Office products (e.g. Outlook, Word, Excel, PowerPoint)
High attention to detail
Excellent communication and interpersonal skills

Nice To Haves

Fluent in English/Spanish preferred

Responsibilities

Coordinating, supervising and monitoring study activities
Following adverse events
Administering study medications
Complying & adhering to GCP guidelines and regulations
Ensuring study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards
Ensuring subject safety at all times
Supporting the Clinical Leads by providing leadership, encouragement, support and positive reinforcement within the clinical team
Deputizing for the Clinical Lead during periods of absence in all aspects of the role including line management
Understanding resource (staffing) requirements for assigned studies
Supervising staff and study events on the unit according to protocol requirements
Making staff adjustments during absences or others unanticipated work circumstances
Monitoring study schedules and reviewing study activities as they progress
Administering study medication to study participants
Reviewing, recording and following adverse events
Responding to medical emergencies in clinic and to adverse events requiring urgent attention
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
Monitoring clinical results, compliance, and/or safety issues which would trigger the exclusion or discontinuation of a participant
Effectively interacting with pharmaceutical company representatives (monitors) and clinical research organizations (CRO) in response to queries during the course of the research study
Participating in key study meetings – SIV, Clinical Kick-off, paperwork review, dummy run, and as required
Assuring that all necessary source documents are available on the unit on a timely basis
Reviewing and performing quality control checks on study source documents for completion, accuracy, and compliance to GCP and protocol
Facilitating clinical training and reassessment of core clinical competencies (e.g. venipuncture, cannulation, safety assessments, holter monitoring, etc.)
Supporting 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
Ensuring all members of clinical team are fully trained and signed off in relevant SOP/competency before working unsupervised or on a study
Troubleshooting and problem solving as directed by Clinical Lead
Assisting with other nursing duties as assigned