Lead Clinical Research Nurse (Night Shift)

Quotient Sciences: Molecule to Cure. Fast.
We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics® , shortens timelines by 9-12 months on average.

Arcinova , our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept.

Why join us?
Because 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.

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

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.