Clinical Research Coordinator (Onsite)
Comrise Technology
Major Responsibilities:
Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”During your employment with HRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.Performs routine operational activities for multiple research protocolsLiaise between site research personnel, industry sponsors, and SupervisorCollaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicableCoordinates schedule of assessments from initial submission of feasibility until study closeoutReviews the study design and inclusion/exclusion criteria with physician and patientEnsures the protection of study patients by verifying informed consent procedures and adhering to protocol requirementsEnsures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible dataCreates study specific tools for source documentation when not provided by sponsorCollects, completes, and enters data into study specific case report forms or electronic data capture systemsGenerates and tracks drug shipments, device shipments, and supplies as neededEnsures timely and accurate data completionTracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violationsCommunicates all protocol-related issues to appropriate study personnel or managerAttends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as requiredReviews and responds to any monitoring and auditing findings
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