Clinical Research Nurse - Per diem

Quotient Sciences•Miami, FL

2d•Onsite

About The Position

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

Requirements

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
Must be aged 18 years or over
Must not have been debarred by the FDA

Responsibilities

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 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
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