Lead Clinical Research Nurse - Night

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

• Responsible for coordinating, supervising and monitoring study activities, following adverse events and administering study medications
• 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 provide leadership and guidance to the clinical team
• To ensure subject safety at all times
  
  

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
• Organizing training and conducting training, when applicable) for both new and existing members of the clinical team
• Understands resource (staffing) requirements for assigned studies
• Responsible for supervising staff and study events on the unit according to protocol requirements.
• Responsible for making staff adjustments during absences or others unanticipated work circumstances
• Responsible for monitoring study schedules and reviewing study activities as they progress
• Responsible for administering study medication to study participants
• Familiar with intravenous infusion techniques including pumps
• Responsible for timely reviewing, recording and following adverse events
• Responds to medical emergencies in clinic and to adverse events requiring urgent attention
• Responsible for confirming that a complete screening chart containing informed consents, lab results and Investigator approval is available on the day of admission for every admitted subject
• Responsible for monitoring clinical results, compliance, and/or safety issues which would trigger the exclusion or discontinuation of a participant
• Ability to effectively interact with pharmaceutical company representatives (monitors) and clinical research organizations (CRO) in response to queries during the course of the research study
• Participates in key study meetings – SIV, Clinical Kick-off, paperwork review, dummy run, and as required
• Assures that all necessary source documents are available on the unit on a timely basis
• Reviews and performs quality control checks on study source documents for completion, accuracy, and compliance to GCP and protocol
• Facilitates clinical training and reassessment of core clinical competencies (e.g. venipuncture, cannulation, safety assessments, holter monitoring, etc.)
• Ensures all members of clinical team are fully trained and signed off in relevant SOP/competency before working unsupervised or on a study
• Familiarity with crash cart emergency procedures
• Troubleshooting and problem solving as directed by Clinical Lead/Clinical Manager
• Assists with other nursing duties as assigned
  
  

The Candidate

• BSN or RN with at least 6 months experience of working in a clinical research environment or equivalent experience in another role
• Current/valid Florida nursing license
• Current Advanced Cardiac Life Support (ACLS) certification
• Fluent in English/Spanish preferred
• Computer proficient in Microsoft Office products (e.g. Outlook, Word, Excel, PowerPoint)
• High attention to detail
• Excellent communication and interpersonal skills
  
  

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation 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 organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, 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.