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Cedars-Sinai Clinical Research Coordinator I - Gastroenterology/Hepatology in Los Angeles, California

Do you have a passion for helping human kind?

We are seeking a Clinical Research Coordinator I to 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. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; presents 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). Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

  • 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; presents this information at regular research staff meetings

  • Notifies direct supervisor about concerns regarding data quality and study conduct

  • Independently works with external study monitors and/or auditors

  • 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

  • May supervise Clinical Research Associates on data entry, data query and resolution

  • 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 Duties and Resposibilities:

  • Responsible for all site coordination of U01 clinical trial investigating treatment of liver disease

  • Serves as primary support for PI, co-investigators and fellows on the study

  • Coordinator will screen, refer and coordinate patient enrollment, assist PIs with informed consent process, biosample collection/ and shipping coordination

  • Maintain informational and human specimen databases and follow-up on study participants

  • Assists in preparation for site monitor visits and external/internal audits, will be expected to collaborate with pharmacists to maintain accountablity of investigational products

Education Requirements:

  • Bachelor of Arts or Sciences degree, required

Licenses/Certifications:

  • ACRP/SoCRA (or equivalent) certification, preferred

Experience:

  • Two (2) years of directly related experience, required

  • Experience with NIH funded clinical trials is highly preferred

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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