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Clinical Research Assistant- 229351

2 months ago

West Columbia, United States Medix™ Full time

The research assistant plays a key role in supporting research patient visits, ensuring adherence to ICH-GCP guidelines, and following the IRB-approved study protocol and/or manual of procedures. Daily responsibilities may vary based on individual experience and organizational needs, which can change over time.


Responsibilities:

  • Schedule and coordinate subject visits according to protocol guidelines and study-specific windows.
  • Prepare visit-related documentation and charts for the Clinical Research Coordinator.
  • Observe and support the Coordinator in patient care and management.
  • Assist the Coordinator in monitoring subject flow and providing care.
  • Collect and record necessary data for follow-up during study visits (Phase 2 & 3; excluding Gene Therapy), including adverse events and concomitant medications.
  • Transcribe study information from source documents to Electronic Case Report Forms.
  • Administer all required questionnaires to study subjects.
  • Set up, prepare subjects, and conduct electrocardiograms (ECGs) as needed according to the study protocol.
  • Promptly request and manage medical records for Serious Adverse Event Reporting.
  • Process and ship biological samples for laboratory analysis.
  • Perform intraocular pressure checks following injections.
  • Conduct trial frame refraction and ETDRS visual acuity testing (for ISTs only, at designated sites).
  • Inform subjects and obtain written re-consent for Informed Consent Forms (ICFs).
  • Perform other duties as assigned.