Clinical Research Assistant - 246616

Job Title : Research Assistant

Position Type : Part-Time

Schedule : We will discuss this - This is a PART TIME position.

• Approximately 3 days per week (Monday, Wednesday, Friday), 8-hour shifts (8 : 30 / 9 -5pm).
• Some flexibility required depending on active clinical trials — occasional Tuesday / Thursday coverage or half-day mornings (8 : 30–9 : 00 AM start) may be needed.
• Schedule typically finalized 1–2 months in advance so you would get the schedule ahead of time to plan.
• Please note -This job is part-time so there are not typical benefits. The benefit is flexibility!

Reports To : Clinical Trials Supervisor

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 :

Minimum Qualifications :

• Education : High School diploma or the equivalent, with significant relevant experience
• College degree preferred
• Ophthalmic experience preferred

Experience / Knowledge / Skills :

• 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