Clinical Research Assistant

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.
• Aid 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.