Lead Clinical Research Nurse - Evening
Quotient Sciences
Quotient Sciences: Molecule to Cure. Fast.
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.
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
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
- 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.
Our Approach to AI in Recruitment
At Quotient Sciences, we use technology, including AI-enabled tools, to support parts of our recruitment process and help create an efficient, consistent, and inclusive candidate experience. Any use of AI is subject to human oversight, and hiring decisions are made by people, not technology.
While we embrace innovation, our recruitment process remains deeply human. Candidates who progress through our recruitment process are supported by a dedicated recruitment contact, and many of our selection processes include in-person interviews. We believe the best hiring decisions come from real conversations, giving candidates the opportunity to meet future colleagues, experience our culture and showcase their strengths beyond their application.
We recognize that candidates may choose to use AI tools when preparing applications. We encourage the responsible use of technology to support research, preparation, and drafting. However, applications should reflect your own skills, experiences, and perspectives. Throughout the recruitment process, we assess authenticity, critical thinking, technical capability, and the unique contribution you can bring to Quotient Sciences. Content generated entirely by AI may not provide an accurate representation of your suitability for the role.
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