Ref No.

CO-21-14

Location

US ~ Miami

Clinical Lead

Company Overview

Our growing and successful business comprises of over 900 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, specialising 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

  • To ensure delivery of clinical studies on time and to a high quality by managing and    co-ordinating 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 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 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 preferred; Bachelors degree in scientific discipline required
  • 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

 

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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