Job Details
Position Summary
The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP
guidelines and according to the 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.
Job Description
Level I
Minimum Qualifications:
Education:
o High School diploma or the equivalent, with significant relevant experience
o College degree preferred
o Ophthalmic experience preferred
Experience / Knowledge / Skills:
o Effective oral and written communication
o Delivers safe and appropriate care to patients in addition to the requirements outlined by
study protocols
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 ETDRS visual acuity testing (For ISTs only, at selected sites)
Inform subjects and obtain written re-consents in regard to ICF s
Perform other duties as assigned
Obtain any applicable additional/required sponsor training and/or certifications
Level II
Minimum Qualifications:
Experience / Knowledge / Skills:
o RA Level I >3 months 1 year
Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job
requirements
Duties:
All duties included in RA Level I in addition to:
Assist Coordinator in CTMS management
Review and resolve data management queries as needed
Inform subjects and obtain written consent in regard to ICF s (on selected studies)
Observe and assist scribe in ocular exams for doctors and confirm appropriate treatment per protocol
Submit images to CRCs as needed
Level III
Minimum Qualifications:
Experience / Knowledge / Skills:
o RA Level II > 6months - 1 year
Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job requirements
Duties:
All duties included in RA Level II in addition to:
Assist and perform unmasked duties for ISTs and Phase 1 studies, including maintaining IP and
shipping logs
Perform Serious Adverse Event reporting, initial & follow up reporting, including the prompt
request of all necessary medical records, review of medical records and updated reporting
Train and understand all aspects of regulatory compliance
Assist Coordinator in regulatory management, including training and monitoring visits
Transcribe and perform query resolution regarding subject study information from source
documents to the Electronic Case Report Forms
Minimum Demonstrated Skills/Qualifications:
Efficiently and accurately interviews patients and documents histories
Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications
Accurately performs: labs, ECG, tonometry, pupil exam, data entry, and other specified duties
Possesses excellent organizational skills to independently manage workflow
Pays meticulous attention to detail
Takes initiative
Possesses insight and energy to prioritize quickly
Demonstrates high-level critical thinking skills
Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive,
energetic, and professional manner
Demonstrates excellence in communication skills, both personal and written
Abounds in organizational and time-management skills