Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements. Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of researchers develop some of the most advanced clinical trials in the world. Here, you will be a part of leading-edge cancer research history that improves and enhances our patients' treatment options, one trial at a time.
The Breast Oncology Research Program is looking for a strong Clinical Research Coordinator to join their team. The Breast Oncology Program atthe Samuel Oschin Comprehensive Cancer Institute is a multidisciplinaryprogram, conducting early and late-phase clinical trials to improve the livesof patients with breast cancer. Our research program focus is wide-ranging andincludes, innovative surgical techniques, novel treatments, and cutting-edgetranslational research to develop new treatment options and improve clinicaloutcomes.Do you have a passion for helping human kind?
As Clinical Research Coordinator (CRC) I for the Breast Oncology Program, you will work 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. You will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
As a Clinical Research Coordinator I, you will also be responsible for the following:
-Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information
-Document thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
-Maintain accurate source documents related to all research procedures.
-Schedule patients for research visits and procedures.
-Schedule and participate in monitoring and auditing activities.
-Notify direct supervisor about concerns regarding data quality and study conduct.
-Work with regulatory coordinators 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 assist with other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
-Maintain research practices using Good Clinical Practice (GCP) guidelines.
-Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
-Participates in required training and education programs.
This position is eligible for the Employee Referral Program. See website for details: http://careers.cedars-sinai.edu/working-here/employee-referrals/Educational Requirements:
BA/BS degree, requiredLicense/Certification/Registration Requirements:
ACRP/SoCRA (or equivalent) certification, preferredExperience:
Two (2) years of directly related experience
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