Clinical Research Associate I, Per Diem
- Cedars Sinai
- Location: West Hollywood, CA
- Job Number: 7171780 (Ref #: HRC1282713)
- Posting Date: Jul 26, 2023
- Application Deadline: Open Until Filled
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. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. 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. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary 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) including submission of 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.
- May assist with screening and consenting patients
- May assist with biological sample coordination, collection, transportation, and storage. Can include but not limited to blood products, tissue, etc.
- May process biospecimen (e.g. blood, stool)
- Assists with chart review and data mining from a variety of Cedars-Sinai systems including but not limited to EPIC, DEEP 6, and PowerPath Client.
- Monitors inventory levels, orders materials and supplies in accordance with established policies and procedures, and conduct quality and assurance on orders upon receipt.
- High School Diploma/GED
Working Title: Clinical Research Associate I, Per Diem
Department: Cancer Institute
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:$19.50 - $29.87