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The Clinical Research Coordinator I works independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This position presents this information at research staff meetings and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
This position supports Pancreatic Biliary clinical research, which focuses on improving outcomes in pancreatic cancer through development of interventions focused on quality of life, reducing tumor burden, improving early detection, and enhancing imaging techniques. We are involved in several international and national research consortium focused on pancreatic cancer and cancer cachexia.
Primary Duties and Responsibilities:
- Schedules research visits and procedures for enrolled participants.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
Department-Specific Responsibilities:
- Collects and documents specimens for translational studies.
- Performs study assessments.
- Collects wearable device data.
- Assess lean body mass.
- Acquires quality of life data.
Education:
- High School Diploma/GED is required.
- Bachelor’s degree is preferred.
Licenses/Certifications:
- ACRP/SoCRA (or equivalent) certification is preferred.
Experience:
- One year of clinical research or coordinating clinical research trials experience is required.
Physical 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 Coordinator I – Pancreatic Biliary
Department: Home Dept – Medicine Research
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$23.39 – $39.76