Clinical Research Assistant

1 month ago

Wildwood, United States Medix Full time
Summary:

The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

Role & Responsibilities:
  • Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.
  • Prepare visit-specific documentation and charts for Clinical Research Coordinator
  • Observe Coordinator in patient care and management
  • Assist Coordinator in monitoring subject flow and assist in subject care and management
  • Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)
  • Transcribe subject study information from source documents to the Electronic Case Report Forms
  • Administer all mandatory questionnaires to study subjects
  • Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol
  • Promptly request all necessary medical records for Serious Adverse Event Reporting
  • Process and ship laboratory biological samples for analysis
  • Perform intraocular pressure checks after injections
  • Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)
  • Inform subjects and obtain written re-consents in regard to ICF's
  • Perform other duties as assigned
  • Obtain any applicable additional/required sponsor training and/or certifications

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