Clinical Research Coordinator

Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed.Identifies and recruits eligible study subjects; conducts informed consent/assent process.Arranges and conducts clinical research visits.Conducts site qualifications, study initiation, monitoring and/or close-out visits.Attends investigator meetings.Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis.Creates and/or updates case report forms and/or source document templates.Coordinates reimbursement of subjects.Maintains inventory of supplies/equipment.Prepares lab kits and requisitions prior to visits.Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly.