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Clinical Trial Nurse

2 months ago

Miramar, Florida, United States Staffing Resource Group, Inc Full time
Job Overview

The Clinical Research Nurse serves as a key liaison for study participants, the Principal Investigator (PI), the Clinical Study Manager (CSM), and departmental supervisors in all matters related to study execution and participant engagement within the clinical research environment.

Key Responsibilities

  • Conducts procedures in strict adherence to study protocols, Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOPs), Quality Assurance/Quality Control (QA/QC) protocols, OSHA regulations, and applicable local and state laws.
  • Monitors and ensures the safety and well-being of study participants through active assessments and by being a consistent point of contact.
  • Facilitates communication between the Principal Investigator (PI) and study participants or clinical staff, ensuring clear and effective follow-through.
  • Assists the PI in reviewing laboratory data for participant selection and randomization, as well as monitoring safety parameters throughout the study.
  • Continuously assesses study subjects to identify Adverse Events (AEs), ensuring accurate documentation and reporting, including follow-up on unresolved AEs, and providing necessary clinical care as directed.
  • Maintains ongoing communication regarding study progress with the PI, CSM, and clinical study team members through various communication methods.
  • Immediately informs the PI, CSM, and clinic management team of any Serious Adverse Events (SAEs) reported by study participants and initiates necessary documentation.
  • Enforces compliance with study regulations and effectively addresses participant concerns to maintain satisfaction.
  • Ensures accurate and compliant study documentation, including records of AEs and concomitant medication usage throughout the study duration.
  • In the absence of the Clinical Study Manager, acts as the floor leader, providing guidance to research technicians, clinical research nurses, and laboratory staff as needed.
  • Exhibits professionalism and leadership to all members of the clinical study team.
  • Administers study medications in accordance with study protocols, demonstrating a thorough understanding of the medications involved, and maintains accurate documentation of these processes.
  • Coordinates with scheduling teams to ensure adequate coverage for clinical activities.
  • Collaborates with the CSM and Training Manager to deliver protocol training to the clinical study team and provides real-time performance feedback as necessary.
  • Oversees the completion of all End of Study or Early Termination activities, including follow-up for outstanding items after participant discharge.
  • Provides administrative and operational support to facilitate the successful execution of study protocols.

Qualifications

  • 1-2 years of experience in a clinical research setting.
  • A nursing degree and valid state licensure are mandatory.
  • Advanced Life Support (ALS) certification is required.

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