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Clinical Research Assistant-235861

Clinical Research Assistant-235861

MedixSouthaven, MS, US
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SEEKING A CLINICAL RESEARCH ASSISTANT IN MADISON, MISSISSIPPI

The research assistant is primarily responsible for assisting in research patient visits according to International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and according to the Institutional Review Board (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.

Duties :

  • 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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    Clinical Research • Southaven, MS, US