Job Description

The research coordinator is responsible for coordinating research patient visits according to the ICH-GCP guidelines and 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. Responsibilities:

• Coordinate and schedule subject visits within study/subject-specific windows per protocol guidelines
• Prepare visit-specific documentation and charts for the Clinical Research Coordinator
• Observe the Coordinator in patient care and management
• Assist the 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 subjects, and conduct electrocardiograms (ECG) on subjects as required per the 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 regarding ICFs
• Perform other duties as assigned
• Obtain any applicable additional/required sponsor training and/or certification

Qualifications:

• Possess high energy, and have a positive, professional attitude
• Strong communication skills with a team-player approach
• Critical time management skills
• Certifications/Trainings
• ICH GCP Training/Certificate
• IATA Certification
• Adhere to ongoing training and education
• Demonstrate effectiveness by showing courtesy, diligence, integrity, and teamwork
• Other functions may be assigned, and management retains the right to add or change the duties at any time

About Company: Benefits: Paid Time Off + Holidays, Medical Insurance, Vision, Dental, 401(k), Life InsuranceTravel within 120 miles is required (company-provided transportation, day trips only), which can mean early mornings and long daysSchedule varies depending on the assigned role and/or assigned physicianPhysical Demands and Abilities: Ability to stand and walk for long periods, ability to lift more than 30 lbs

Job Tags

Early shift,

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