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