Clinical Research Assistant
Summary:
The 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.
Role &
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
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