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!

We invite you to consider this phenomenal opportunity!

As a Clinical Research Associate I / CPT, Per Diem, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. You will be responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Additionally, you will provide limited contact with research participants as needed for study and assists with study budget and research participant billing. You will be expected to comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Essential job duties and responsibilities:

• Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse or Principal Investigator 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 contact with research participants or contact for long term follow-up research participants 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.


• Assists with patient research billing.


• 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.

Educational Requirements:

• BA/BS Degree is strongly preferred

License/Certification/Registration Requirements:

• Phlebotomy certification (LPT, CPT I or CPT II) within the state of California from an accredited agency is required

Experience:

• Understanding of general clinical research objectives. Clinical research experience, preferred.


• Previous experience as a phlebotomist, highly preferred.

Working Title: Clinical Research Associate I/CPT - Per Diem - Cheng Lab
Department: Heart Institute Operations
Business Entity: Cedars-Sinai Medical Center
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Per Diem
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$18.00 - $29.87