Research Assistant
: Job Details :

DescriptionThe 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 certificationQualifications•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