Lead Clinical Research Nurse - Evening

• 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

• 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 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

• 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…