Clinical Research Assistant

Clinical Research Assistant

The Research Assistant position is responsible for all research-related lab duties, such as collecting and shipping biological samples, and for providing administrative research support and direct patient care activities while following strict protocols and directives from leadership.

Essential Functions

Protocol and Regulatory Compliance

• Ensure that procedures are conducted according to each individual IRB-approved clinical trial protocol; sponsor instructions; established company policies and procedures; applicable state and federal regulations; Good Clinical Practices (GCPs); and ICH/FDA guidance documents.
• Acknowledge and sign regulatory documents in accordance with applicable timelines and study requirements.
• File and maintain appropriate documentation associated with assigned clinical studies, including investigational product storage and accountability.

Patient Recruitment & Enrollment Execution

• Identify, screen, schedule, and enroll eligible participants into IRB-approved clinical trials in a timely and compliant manner.
• Explain study protocols and requirements clearly to prospective participants and obtain informed consent following ethical and regulatory standards.
• Carry out delegated duties ensuring adherence to the study schedule to support enrollment goals and minimize dropout rates. 
• Participate in site recruitment efforts.

Clinical & Patient Care Proficiency

• Draw, prepare, process, and package blood and other biological specimens according to study protocols and IATA shipping regulations.
• Record and maintain temperature logs to ensure specimen integrity and equipment compliance.
• Perform or assist with direct patient care activities as delegated, including:
  • Informed consent process
  • Physical assessments and medical history intake
  • Vital signs measurement (BP, pulse, temperature, respiration, height, weight)
  • Blood draws and handling of biological specimens
  • FibroScans and ECGs 
  • Identify potential abnormalities in 6 standard vital signs and escalate findings appropriately.

Data Integrity and Documentation Accuracy

• Ensure that study data is complete, accurate, and entered promptly into the sponsor’s Electronic Data Capture (EDC) system according to protocol timelines and expectations.
• Create and maintain up-to-date and compliant source documentation (paper-based and/or electronic) for each study participant visit and study-related task.