Cedars-Sinai Clinical Research Coordinator II in Los Angeles, California

Job Posting: The Cedars-Sinai F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute (IBIRI) is searching for a Clinical Research Coordinator II. IBIRI is a multidisciplinary basic, translational and clinical research program devoted to Inflammation Bowel Diseases. Under the direction of Dr. Gil Melmed, the institute is seeking a talented and highly motivated candidate to join the group as a Clinical Research Coordinator II. The Clinical Research Coordinator II 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. 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. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board IRB). Essential Job Duties and Responsibilities, but no limited to: Works closely with regulatory coordinator or directly with the Institutional Review Board (1RB) to submit initial study/protocol applications (investigational drugs, devices, repositories. and placental-derived cells), consent forms and sub-study consents, amendments, continuation reviews. Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. - Interactions with 1R13 analyst, industry sponsors, SRFA, and monitors. - Coordinating and maintaining clinical trial regulatory documents and binders (

  1. Financial disclosures. licenses, study and amendment approvals) on site and communicating changes to the sponsor. - Laboratory kit/supply ordering, processing and shipping. Transportation of Dangerous Goods Certification (1ATA). - Performs other related duties as assigned or required.

Qualification Requirements/Preferences:

Education Certifications/Licensure Experience Physical Abilities

Educational Requirements:

BA/BS degree

License/Certification/Registration Requirements:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

Four (4) years minimum of directly related experience in clinical research coordination.

Physical Demands: (e.g., lifting. Standing, walking)

Able to perform moderate lifting. May require occasional driving to offsite location. Able to sit, stand, and walk for prolonged periods of time. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions