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Open nowPosted 9 days ago

Lead Clinical Research Nurse - Evening

quotientsci25 open roles

Where
Miami, FL, USA
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Your applicationOpen nowLead Clinical Research Nurse - Eveningquotientsci · Miami, FL, USA

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The clock on this job

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Share of postings closed within
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  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 9 days ago

The posting

The Role

Overall responsibility for quality of laboratory processing for assigned studies  To ensure delivery of clinical studies on time and to a high quality by managing and coordinating staff to maximize operational efficiency  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  To provide leadership and guidance to the clinical team  To ensure excellent clinical standards within the clinic 

Main Tasks and Responsibilities

Provides leadership, encouragement, support, positive reinforcement and job enrichment opportunities to direct reports by undertaking regular 1:1s, objective setting and regular team meetings   Effectively manages assigned clinical team to ensure the smooth delivery of studies  Completes study resource allocations and attend clinical scheduling meetings to ensure co-ordination of the clinic team to maximize operational efficiency. Works with Clinical Scheduling Manager and ensures studies are scheduled and staffed to maintain subject safety  Organizing training (and conducting training, when applicable) for both new and existing members of the clinical team  Ensures all members of the clinical team are fully trained and signed off in the relevant SOP/competency before working unsupervised or on a study  Troubleshooting and problem solving on assigned studies or as needed   Administration of medication and recording of adverse events as required by resource allocations   Clinical duties as needed e.g. collection and processing of blood samples, taking blood pressure, ECGs etc. in accordance with ICH-GCP  Ensures timely and proper follow up of adverse events  Responds to medical emergencies in the clinic and adverse events requiring urgent attention accordingly  Oversight of compliance and delivery of the study when in clinic ensuring source document completion is to a high standard and performing quality checks accordingly   Ensures study KPIs (PDs and Query metrics) are within the set targets ensuring regular feedback to the team on trends/issues/learnings throughout the study and on completion. Feed improvements into the data quality workstream to drive continual improvement within the clinic  Works with the Deputy Lead(s) and technicians within the team to ensure that all study paperwork and training (dose/protocol etc.) for the clinical team is accurate and in place for the study   Attends and effectively participates in all key study meetings – SIV, Clinical Kick-off, paperwork review, dummy run, post lock review meeting for assigned studies  Ensures all study specific equipment is validated prior to first dose where applicable   Ensures all study specific consumables are ordered in time for the study start   Assists in assigned study specific client audits, regulatory inspections, and site visits  When allocated acts as a shift lead to ensure effective management of shifts/study days   Monitors compliance and support audit readiness at all times   Coordinates BLS/ACLS training/scenarios to ensure compliance with Quotient SOPs  Supports QA with general audits   Supports PM and commercial team in general site visits to promote new business opportunities  Ensure clinical equipment is maintained in good working order, ensure logbooks for clinical equipment are completed timely and archived appropriately  Writing, updating and reviewing clinical SOPs and working instructions where required   Proactively promote working in a safe and responsible manner at all times   Interviewing and appointing new staff to assigned clinical team   Investigate quality issues and identify appropriate CAPAs  Identify opportunities for change and assist with implementation of process change  Support screening activities via Nurse Led Information sessions, Informed Consent and medical histories according to the needs of the business 

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 

The Candidate

Active Florida Registered Nurse License  At least 2 years of clinical experience  At least 2 years experience of working in a clinical research environment or equivalent experience in another role   High attention to detail   Excellent communication and interpersonal skills   Current Advanced Cardiac Life Support (ACLS) certification 

 

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