Clinical Research Specialist

2 weeks ago

Miramar, Florida, United States Cynet Systems Full time
Job Description

We are seeking a Clinical Research Specialist to join our team at Cynet Systems.

Position Overview:

The Clinical Research Specialist will play a crucial role in ensuring the integrity and compliance of clinical studies.

Key Responsibilities:

  • Conducts clinical procedures in accordance with study protocols, Good Clinical Practice (GCP) standards, and applicable regulations.
  • Monitors the safety and well-being of study participants, serving as a primary contact throughout the study.
  • Facilitates communication between the Principal Investigator (PI) and study participants, ensuring clear instructions and follow-through.
  • Assists the PI in reviewing 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 ongoing communication with the PI and clinical study team regarding study progress.
  • Immediately reports Serious Adverse Events (SAEs) to the PI and relevant team members, initiating necessary documentation.
  • Enforces study regulations and addresses participant concerns effectively to maintain satisfaction.
  • Ensures accurate and compliant documentation of study charts and all reported AEs.
  • In the absence of the Clinical Study Manager, leads and mentors the clinical research team on the conduct floor.
  • Demonstrates professionalism and provides guidance to team members.
  • Administers study medications as per protocol and maintains thorough documentation of the process.
  • Coordinates with scheduling to ensure coverage for clinical activities.
  • Collaborates with the Clinical Study Manager and Training Manager to provide protocol training and performance feedback.
  • Oversees the completion of study termination activities, ensuring follow-up on outstanding items post-discharge.
  • Provides administrative support to facilitate the successful execution of study protocols.

Qualifications:

  • A nursing degree and valid state licensure are required.

Experience:

  • 1-2 years of experience in a clinical research setting is preferred.
  • Equivalent combinations of education and experience may be considered.

Skills and Abilities:

  • Strong leadership and customer service skills.
  • Effective verbal and written communication abilities with diverse populations.
  • Ability to work independently while managing multiple priorities.
  • Excellent organizational skills and attention to detail.

Physical Requirements:

  • Ability to lift up to 50 pounds with assistance and to perform various physical tasks associated with the role.
Company Overview

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