Clinical Research Coordinator I - RI Pulmonary

Job description

Overview: Job Description Summary: The Clinical Research Coordinator I manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities. Job Description: Essential Functions: - Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate. - Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination. - Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures. - Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed acco...