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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 vital liaison for study participants, the Principal Investigator (PI), the Clinical Study Manager (CSM), and departmental leaders regarding all aspects of study execution and participant interactions within the clinical research unit.

Key Responsibilities

  • Conducts procedures in strict adherence to study protocols, Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOPs), and relevant regulatory guidelines.
  • Monitors and ensures the safety and well-being of study participants through continuous assessment and by being an accessible point of contact.
  • Facilitates communication between the PI and study participants, ensuring clear instructions and follow-through.
  • Assists the PI in evaluating laboratory data for participant selection and monitoring safety during the study.
  • Continuously assesses study subjects for Adverse Events (AEs), ensuring proper documentation and follow-up care as necessary.
  • Maintains open communication with the PI, CSM, and clinical study team regarding study progress.
  • Immediately reports Serious Adverse Events (SAEs) to the PI and CSM, initiating necessary documentation.
  • Enforces study regulations with participants and addresses complaints effectively to maintain satisfaction.
  • Ensures accurate and compliant documentation of study charts and all reported AEs.
  • Acts as a mentor and leader in the absence of the CSM, supporting research staff as needed.
  • Demonstrates professionalism and leadership within the clinical study team.
  • Administers study medications according to protocols, maintaining accurate records of the process.
  • Coordinates with scheduling to ensure adequate coverage for clinical activities.
  • Collaborates with the CSM and Training Manager to provide training on study protocols and performance feedback.
  • Oversees the completion of all study termination activities, ensuring follow-up on outstanding items post-discharge.
  • Provides administrative and operational support to facilitate successful study protocol execution.

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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