Clinical Research Specialist

2 weeks 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 Department Managers regarding all aspects of study execution and participant-related inquiries within the clinical research unit.

Key Responsibilities

  • Conducts procedures in strict adherence to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOPs), QA/QC protocols, OSHA regulations, and applicable state and local laws.
  • Monitors and ensures the safety and well-being of study participants through proactive assessments and by being a constant point of contact.
  • Facilitates communication from the Principal Investigator (PI) to study participants and clinical study staff, ensuring proper execution of directives.
  • Assists the PI in reviewing laboratory data for participant selection, randomization, and ongoing safety monitoring.
  • Continuously evaluates study subjects to identify Adverse Events (AEs), ensuring thorough documentation and reporting, including follow-up on unresolved AEs, and providing necessary clinical care as directed.
  • Maintains open communication regarding study progress with the PI, CSM, and clinical study team members through various communication methods.
  • Immediately alerts the PI, CSM, and clinic management team of any Serious Adverse Events (SAEs) reported by study participants and initiates the necessary documentation.
  • Enforces compliance with study regulations and efficiently addresses participant concerns to maintain satisfaction.
  • Ensures accurate and compliant study documentation, including charts of all reported AEs and Concomitant Medication usage throughout the study.
  • In the absence of the Clinical Study Manager, assumes the role of floor leader and mentor, supporting research technicians, clinical research nurses, clinical research paramedics, and laboratory technicians as needed.
  • Exhibits professionalism and leadership among the clinical study team members.
  • Administers study medications in accordance with the study protocol, demonstrating a comprehensive understanding of the medications involved, and maintains accurate documentation of these processes.
  • Coordinates with scheduling departments to guarantee coverage for clinical activities.
  • Collaborates with the CSM and Training Manager to provide protocol training to the clinical study team and offers real-time performance feedback as necessary.
  • Oversees the completion of all End of Study or Early Termination activities by study participants, including follow-up for any outstanding items post-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 in-state licensure are mandatory.
  • Advanced Life Support (ALS) certification is required.

EOA/ADA

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