Ref No.

QUO00592

Location

US ~ Miami

Clinical Lead - Nurse

Clinical Lead (Nurse)       

Company Overview

Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

The Role

Due to growth and expansion, we have an exciting opportunity for a Clinical Lead - Nurse to join the Clinical Department. As a Clinical Lead - Nurse, you will primarily be responsible to ensure delivery of clinical studies on time and to a high quality by managing and coordinating staff to maximize operational efficiency.  To ensure study data is collected to a high quality in accordance with ICH-GCP, subject safety at all times, provide leadership and guidance to the clinical team and ensure excellent clinical standards within the clinic.

Other tasks and responsibilities will include:

  • 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 coordination of the clinic team to maximize operational efficiency
  • 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 on the relevant SOP/competency before working unsupervised or in a study
  • Troubleshooting and problem solving on assigned studies or as shift lead
  • 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 continuous 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 the 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
  • 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 the assigned clinical team
  • Investigate quality issues and identify appropriate CAPAs
  • Identify opportunities for change and assist with the 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:

  • A very high concentration of work
  • Ability to prioritize, delegate and make decisions
  • Strict and tight deadlines
  • Having to juggle a range of tasks/issues simultaneously
  • Ability to remain focused
  • Ability to work to a high specification 

The Candidate

The successful candidate will have an active Florida Registered Nurse License with at least 2 years of clinical experience, and 2 years of working in a clinical research environment or equivalent experience in another role.

Other essential skills and experience are:

  • High attention to detail
  • Excellent communication and interpersonal skills
  • Current Advanced Cardiac Life Support (ACLS) certification

Company benefits:

In return, you will receive a competitive salary, a generous benefits package, excellent training, and development, as well as an exciting career within a fast-paced and dynamic business.

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