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Clinical Research Coord II/S.Cheng Lab

Company: CEDARS-SINAI
Location: Montebello
Posted on: November 17, 2022

Job Description:

Job Summary: Key Job ResponsibilitiesThe Clinical Research Coordinator II works 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. Presents 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).Primary 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.--- 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.--- May coordinate training and education of other personnel.--- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.--- May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.--- May identify quality and performance improvement opportunities and collaborate with staff in the development of action -plans to improve quality.--- May identify new research opportunities and present to investigators--- Participates in required training and education programs
Educational Requirements:- Highschool diploma/GED required- Bachelor's degree in related field preferredLicenses:- SOCRA or ACRP certification preferredExperience:- 2 years clinical research or related experience requiredPhysical Demands: - Able to perform moderate lifting. -- Able to sit, stand and walk for prolonged periods of time. -- Able to read papers and online documents. -- Able to operate standard office equipment. -- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Working Title:Clinical Research Coord II/S.Cheng Lab
Department:Heart Institute Operations
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, Montebello , Clinical Research Coord II/S.Cheng Lab, Healthcare , Montebello, California

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