Cedars-Sinai Clinical Research Associate I - Innovation in Imaging / Department of Medicine / Division of AIM - Slomka Lab in Los Angeles, California
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:
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
High School Diploma/GED, required
Bachelor of Art or Sciences degree, preferred
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,Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.