Clinical Research Coordinator II - Kidney/Pancreas Transplant

Company: CEDARS-SINAI
Location: Alhambra
Posted on: May 27, 2023

Job Description:

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai, and it's just one of the many reasons why we rank as one of the top hospitals in the nation by U.S. News & World Report.When you join Cedars-Sinai, you become part of a team that is at the forefront of medical advancements. Working alongside physician-scientists and researchers, you will be a part of life-saving medical and scientific breakthroughsAre you ready to be a part of breakthrough research?The 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 ResponsibilitiesIndependent 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.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; 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 involve 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 Qualifications:

• High School Diploma/GED required
• SOCRA or ACRP certification preferred
• Bachelor's Degree Science, Sociology or related degree preferred
• 2 years Clinical research related experience required Working Title: Clinical Research Coordinator II - Kidney/Pancreas TransplantDepartment: Home Dept-Hepatology&CTCPrgmsBusiness Entity: Cedars-Sinai Medical CenterJob Category: Academic/ResearchJob Specialty: Research Studies/Clinical TrialsPosition Type: Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay:$64,500.00 - $100,000.00

Keywords: CEDARS-SINAI, Alhambra , Clinical Research Coordinator II - Kidney/Pancreas Transplant, Healthcare , Alhambra, California