Clinical Research Assistant (Project Management)

Clinical Research Assistant
Our 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.

Responsibilities
Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines.Prepare visit-specific documentation and charts for Clinical Research CoordinatorObserve 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 ReportingProcess and ship laboratory biological samples for analysisPerform intraocular pressure checks after injectionsPerform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)Inform subjects and obtain written re-consents in regard to ICFsPerform other duties as assignedObtain any applicable additional/required sponsor training and/or certifications