1+ months
2018-06-132018-09-07

Clinical Research Coord I

Cedars-Sinai
The Clinical Research Coordinator I works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Summary of Essential Job Duties: - Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. - Scheduling of patients for research visits and procedures. - In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug. - Maintains accurate source documents related to all research procedures. - Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. - Schedules and participates in monitoring and auditing activities. - Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. - Notifies direct supervisor about concerns regarding data quality and study conduct. - Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. - May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. - Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. - Maintains research practices using Good Clinical Practice (GCP) guidelines. - Maintains strict patient confidentiality according to HIPAA regulations and applicable law. - Participates in required training and education programs. Experience: Two (2) years minimum of directly related experience. Educational Requirements: BA/BS degree License/Certification/Registration Requirements: ACRP/SoCRA (or equivalent) certification preferred. Physical Demands: (e.g., lifting, standing, walking) Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

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Clinical Research Coord I

Cedars-Sinai

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