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 

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