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.
In the Slomka Lab, the primary role of the Clinical Research Associate I is to coordinate and help implement research study activities and perform other tasks directly supporting the projects and the program. Job duties and responsibilities include research data management of NIH-sponsored cardiac imaging registry, manipulations with Excel and feature extraction from image data using image analysis programs, extracting data from medical record review, entering clinical research data, maintaining study documentation, and assisting with reporting results.
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
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Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study
- Evaluates and abstracts clinical research data from source documents
- Ensures compliance with protocol and overall clinical research objectives
- Completes Case Report Forms (CRFs)
- Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors
- Provides supervised patient contact or patient contact for long term follow-up patients only
- Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines
- Assists with clinical trial budgets as needed
- Assists with patient research billing as needed
- Schedules patients for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- 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
- Participates in required training and education programs
Education:
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High School Diploma/GED, required
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Bachelor of Art or Sciences degree, preferred
Experience:
- Understanding of general clinical research objectives. Clinical research experience, preferred.
- 1 year of clinical research related experience, preferred.
Working Title: Clinical Research Associate I – Innovation in Imaging / Department of Medicine / Division of AIM – Slomka Lab
Department: Home Dept – Noble
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:$18.00 – $29.87