Requisition #: 26695
Working Title: Clinical Research Coord II
Business Entity: CSMC - Cedars-Sinai Medical Center
Cost Center # - Cost Center Name: 0739052 - Anesthesia Pain Ctr-Procedures
City: Los Angeles
Job Category: Research/Research Admin
Job Specialty: Research
Position Type: Regular-F/T
Shift Length: 8hr
Hours: 8am - 4:30pm
Days: Monday - Friday
Shift Type: Day
Weekends: As Needed
Job Posting: Summary of Essential Job Duties:
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. 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, p 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 involved 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.
Protocol development, initial IRB submissions, IRB continuing review submissions, IRB amendment submissions, budget development, budget negotiations, project management and development, informed consent development, SOP development, source document development, Financial Tracking (IRB fees, Admin fees, patient visits, PI fees), specimen (processing, shipment, and transport), supply ordering/accountability, maintain patient research records/binders, processing patient payments, tracking patient compliance, equipment calibration/safety review, etc.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
EEO / AA / F / M / Veteran / Disabled
Education Certifications/Licensure Experience Physical Abilities Educational Requirements:
ACRP/SOCRA (or equivalent) Certification preferred
Four (4) years minimum of directly related experience.
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 physicial ability and perspective acuity to satisfactorily perform essential job functions.