Clinical Research Associate

3 days ago


Orlando, Florida, United States ELIXIA LLC Full time
Job Summary

We are seeking a highly skilled Clinical Research Coordinator to join our team at ELIXIA LLC. The successful candidate will be responsible for planning, directing, and coordinating clinical research projects, as well as evaluating and analyzing clinical data.

Key Responsibilities
  • Conduct study subject visits, including screening and recruiting subjects, dosing and administering study drugs, and collecting and shipping specimens.
  • Communicate with subjects and medical group providers, including the Principal Investigator and Sub-Investigators.
  • Enter patient and research data in designated systems and maintain patient charts.
  • Monitor study activities to ensure compliance with study protocols and regulatory requirements.
  • Assess eligibility of potential subjects and oversee subject enrollment.
  • Record adverse events and side effect data and confer with Investigators regarding reporting.
  • Prepare for or participate in quality assurance audits and create source documents as assigned.
  • Review proposed study protocols and instruct research staff in scientific and procedural aspects of studies.
  • Collaborate with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions.
Requirements
  • Knowledge of medical terminology and understanding of principles of administration and management.
  • High School Diploma or degree in nursing or health-related field, with 1-5 years of on-the-job training as a clinical research assistant or research study coordinator.
Continuing Education
  • IATA (dangerous goods handling) and GCP (good clinical practice) training.
  • BLS/Phlebotomist course and CPR course, as arranged by the Company.
  • Stericycle Trainings, first week of start date.
Physical Requirements
  • Prolonged periods of sitting and standing, with occasional lifting of 20 pounds.
  • Travel to sponsor required meetings as needed.
  • Exposure to human bodily fluids.
  • Occasional night and weekend work schedules, with overtime as required.


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