Research Assistant
2 weeks ago
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
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