Clinical Research Assistant

We are looking to add a full time Clinical Research Assistant to our growing team.We promote from within, have a great company culture and value work life balance. Competitive salary, great benefits package and bonus eligible.

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.

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

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
• 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
• 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

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