Clinical Research Coordinator I - Phase 1 - Cancer Clinical Trials Office

Company: CEDARS-SINAI
Location: Anaheim
Posted on: November 16, 2022

Job Description:

At Cedars-Sinai, we're motivated by a collective spirit of innovation and the challenge to continuously improve. Above all, we share a real dedication for helping others. Day after day, from department to department, our people give their all to create a community unlike any other. This is just one of the many reasons U.S. News & World Report has named us one of America's Best Hospitals-and now we invite you to join us and make a difference every single day in service of this outstanding work - excellence and innovation in patient care, research, and community service. From working with a team of committed professionals to using state-of-the-art facilities, you'll have great resources to do something incredible-for yourself, and for others!Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.Are you looking to contribute to groundbreaking research? We look forward to having you come and join our team!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).Duties and Responsibilities

• 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.
• 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.
• Performs phlebotomy services according to CSMC policies and procedures.
• Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing
  
  • High School Diploma/GED required
  • Bachelor's Degree Science, Sociology or related degree preferred
  • One year of Clinical Research Related experience required
  • Certification in clinical Research: SOCRA or ACRP certification preferred
    Working Title:Clinical Research Coordinator I - Phase 1 - Cancer Clinical Trials Office
    Department:SOCCI Clinical Research Office
    Business Entity:Academic / Research
    Job Category:,Academic/Research,Academic/Research
    Job Specialty:Research Studies/Clinical Trials
    Position Type:Full-time
    Shift Length:8 hour shift
    Shift Type:Day

Keywords: CEDARS-SINAI, Anaheim , Clinical Research Coordinator I - Phase 1 - Cancer Clinical Trials Office, Other , Anaheim, California