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 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 in regard to ICF’s • 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 Compensation: $19 hourly
• 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 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 in regard to ICF’s • Perform other duties as assigned • Obtain any applicable additional/required sponsor training and/or certification