Deputy Lead

Quotient Sciences•Miami, FL

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. 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 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 ensure subject safety at all times

Requirements

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
Computer proficient in Microsoft Office products (e.g. Outlook, Word, Excel, PowerPoint)
High attention to detail
Excellent communication and interpersonal skills

Nice To Haves

Fluent in English/Spanish preferred

Responsibilities

Supports the Clinical Leads by providing leadership, encouragement, support and positive reinforcement within the clinical team
Deputizes for the Clinical Lead during periods of absence in all aspects of the role including line management
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
Paticipates 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.)
Supports training for both new and existing members of clinical team; assists with new full time and per diem employee training by providing orientation to general study procedures and responsibilities
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
Assists with other nursing duties as assigned