Jobs · Research

Clinical Research Laboratory Assistant [Bilingual]

Y-axis Global · Miami, FL · 4 days ago
ResearchFull-time

About the role

The Clinical Research Laboratory Assistant is responsible for collecting, preparing, and processing patient samples for testing in accordance with study protocols, ICH/GCP guidelines, sponsor requirements, and Rovia SOPs. This role partners closely with site teams to support study startup, enrollment, data quality, and overall study success.

Responsibilities

  • Conduct and coordinate patient visits in accordance with study protocols.
  • Perform clinical tasks such as vital signs, ECGs, specimen collection/processing, and phlebotomy.
  • Process samples for testing including centrifugation, storage, and shipping.
  • Ensure informed consent is properly obtained and documented.
  • Educate and guide participants throughout the study, ensuring a positive patient experience.
  • Monitor subject safety, report adverse events, and escalate concerns as appropriate.
  • Complete timely and accurate source documentation and EDC data entry.
  • Resolve data queries and ensure data integrity.
  • Maintain investigational product accountability and proper storage/handling.
  • Prepare for and support monitoring visits, audits, and inspections.
  • Collaborate with site staff and investigators to ensure protocol adherence and efficient visit flow.
  • Perform other duties as assigned.

Requirements

Strong knowledge of medical terminology and clinical procedures. Understanding of ICH/GCP and regulatory requirements. Excellent organizational skills and attention to detail. Strong interpersonal and patient-facing communication skills. Ability to multitask and manage competing priorities in a fast-paced environment. Proficiency in Microsoft Office, EDC, and CTMS applications. Ability to work both independently and collaboratively. High level of professionalism and commitment to patient confidentiality.

Qualifications

A high school diploma required, bachelor’s degree in related field preferred. Lab experience required. Experience with patient-facing activities (phlebotomy, vital signs, EKGs, etc.) required. Clinical research experience preferred.

Skills

  • Phlebotomy
  • Specimen Processing
  • Vital Signs
  • ECG
  • ICH/GCP Guidelines
  • Medical Terminology
  • EDC
  • CTMS
  • Patient Communication
  • Data Integrity
  • Microsoft Office
  • Clinical Research Industry
  • Biotechnology Research

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