Clinical Research Assistant

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 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