Clinical Research Assistant

Job Description

Job Description

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.