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.
