Clinical Research Coordinator I_Thoracic

Company: CEDARS-SINAI
Location: Alhambra
Posted on: May 26, 2023

Job Description:

The Clinical Research Coordinator I works independently providing study coordination, 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. Presents study 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).What will you be doing:

• 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.
• Schedules 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 perform 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.Department-Specific Responsibilities
  • Performs phlebotomy services according to CSMC policies and procedures. Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely.
  • Reports test results to appropriate individuals and exercises professional discretion with patient information Requirements:
    • High School Diploma/GED
    • 1 year of Clinical research related experience#Jobs Working Title: Clinical Research Coordinator I_ThoracicDepartment: SOCCI Clinical Research OfficeBusiness Entity: Cedars-Sinai Medical CenterJob Category: Academic/ResearchJob Specialty: Research Studies/Clinical TrialsPosition Type: Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay:$23.39 - $39.76

Keywords: CEDARS-SINAI, Alhambra , Clinical Research Coordinator I_Thoracic, Healthcare , Alhambra, California