SEEKING A CLINICAL RESEARCH ASSISTANT IN MADISON, MISSISSIPPI
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 CoordinatorObserve Coordinator in patient care and managementAssist Coordinator in monitoring subject flow and assist in subject care and managementObserve, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitantmedications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)
Transcribe subject study information from source documents to the Electronic Case Report FormsAdminister all mandatory questionnaires to study subjectsSet up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per studyprotocol
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 ICF'sPerform other duties as assignedObtain any applicable additional / required sponsor training and / or certifications