NC Retina Associates is looking for a Research Assistant to join our team! 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 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 Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing (For Investigator Sponsored Trials (IST)s only, at selected sites).
Inform subjects and obtain written re-consents in regard to Informed Consent Form (ICF)’s (selected studies)
Observe and assist scribe in ocular exams for doctors and confirm appropriate treatment per protocol.
Perform other duties as assigned.
Obtain any applicable additional/required sponsor training and/or certifications.
Minimum Qualifications:
High School diploma or the equivalent, with significant relevant experience.
College degree preferred.
Ophthalmic experience preferred.
Effective oral and written communication.
Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols.