Clinical Research Assistant-235861

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