Clinical Research Assistant

Description

Minimum Qualifications:

• Education:
o High School diploma or the equivalent, with significant relevant experience
o College degree preferred
o Ophthalmic experience preferred

• Experience / Knowledge / Skills:
o Effective oral and written communication
o Delivers safe and appropriate care to patients in addition to the requirements outlined by
study protocols

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