Clinical Research Nurse - Evening Shift

Quotient Sciences•Miami, FL

11d

About The Position

The Clinical Research Nurse coordinates, supervises, and monitors study activities, follows adverse events, and administers study medications. The role requires compliance with Good Clinical Practice (GCP) guidelines and regulations, high-quality study data collection, and continuous attention to participant safety. The nurse supervises staff and study events on the unit according to protocol requirements, monitors study schedules and activities, reviews and documents adverse events, and monitors clinical results, compliance, and safety issues that could lead to participant exclusion or discontinuation. The role also includes coordinating with pharmaceutical company monitors and clinical research organizations (CROs), participating in study meetings, ensuring source documents are available and complete, responding to medical emergencies, and helping orient new employees to general study procedures and responsibilities.

Requirements

BSN or RN; experience preferably in a critical care setting and/or clinical research environment.
Current, valid Florida nursing license.
Current Advanced Cardiac Life Support (ACLS) certification.
Proficiency with intravenous infusion techniques, including pumps.
Computer proficiency with Microsoft Office products, such as Outlook and Word.
High attention to detail.
Excellent communication and interpersonal skills.

Nice To Haves

Fluency in English and Spanish.

Responsibilities

Administer study medication to study participants.
Supervise staff and study events on the unit according to protocol requirements.
Adjust staffing in response to absences or other unanticipated work circumstances.
Monitor study schedules and review study activities as they progress.
Review, record, and follow adverse events.
Confirm that each admitted subject has a complete screening chart—including informed consents, lab results, and Investigator approval—available on the day of admission.
Monitor clinical results, compliance, and safety issues that could trigger participant exclusion or discontinuation.
Respond to queries from pharmaceutical company representatives (monitors) and clinical research organizations (CROs) during research studies.
Participate in key study meetings, including SIV, Clinical Kick-off, paperwork review, and dummy runs, as required.
Ensure necessary source documents are available on the unit in a timely manner and review them for completion.
Respond to clinic medical emergencies and adverse events requiring urgent attention, using familiarity with crash cart emergency procedures.
Assist with other nursing duties as assigned.
Assist with training new regular and per-diem employees by orienting them to general study procedures and responsibilities.
Comply with applicable GCP guidelines and regulations and ensure study data is collected to GCP standards.
Maintain participant safety at all times.