Clinical Research Assistant

North Carolina Retina Associates; Wake Forest (NC); On-site; USD 42,000 - 62,000; Full time

Job summary

NC Retina Associates is seeking a Research Assistant to support clinical research visits in accordance with ICH-GCP guidelines and IRB-approved protocols. The role involves coordinating visits, preparing documentation, and recording data for follow-up, with emphasis on ophthalmic study procedures.

The position requires strong communication and patient care skills, and opportunities to gain experience in ETDRS testing, ECGs, and data management within investigator-initiated trials.

Qualifications

• High School diploma or equivalent with relevant experience.
• College degree preferred.
• Ophthalmic experience preferred.
• Effective oral and written communication.
• Delivers safe and appropriate care per study protocols.

Responsibilities

• Coordinate and schedule subject visits within study/protocol windows.
• Prepare visit documentation for Clinical Research Coordinator.
• Observe Coordinator in patient care and management.
• Assist Coordinator in monitoring subject flow and management.
• Observe, assist, collect and record data for follow up (e.g. adverse events, concomitant medications).
• Transcribe study information from source documents to the Electronic Case Report Forms.
• Administer all mandatory questionnaires to study subjects.
• Set up, prepare subject, and conduct ECGs on subjects as required per protocol.
• Request medical records for Serious Adverse Event Reporting.
• Process and ship laboratory samples for analysis.
• Perform intraocular pressure checks after injections.
• Observe and assist scribe in ocular exams and confirm treatment per protocol.
• Perform other duties as assigned.
• Obtain sponsor training and/or certifications as needed.

Skills

Communication

Patient care

Data collection

Education

High School diploma or equivalent

College degree

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.