What are the responsibilities and job description for the Clinical Research Assoc II - Smidt Heart Institute - Dr. Raj Makkar Lab position at Cedars-Sinai?
As a Clinical Research Associate II, you will work 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. You will be responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provide limited patient contact as needed for study and assist with study budget and patient research billing. Will 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 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.
- 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.
Qualifications:
Education requirements:- BA/BS degree required
Experience:
- Minimum two (2) years of directly related experience
Heart Institute Clinical Research Associate I Makkar Group
Marina Del Rey Hospital -
Los Angeles, CA
Heart Institute Clinical Research Associate I - Makkar Group
Marina Del Rey Hospital -
Los Angeles, CA
Research Admin Coordinator - Smidt Heart Institute
CEDARS-SINAI -
Los Angeles, CA
