Heart Institute Clinical Research Associate I - per diem/ Cheng Lab

Cedars Sinai • Los Angeles, CA

111d • $19 - $32

About The Position

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.

Requirements

• High School diploma/GED required.
• BA/BS degree in Science, Sociology or related degree preferred.
• Understanding of general research objectives.
• 1 year of clinical research related experience preferred.
• Excellent language skills and understanding of Grants, Manuscript, and Abstract guidelines.
• Strong verbal and writing ability as well as communication, computer, organization, personnel and time-management skills.
• Proficiency in Word, PowerPoint and Excel.
• Ability to work independently, set priorities, and handle multiple tasks requiring attention to detail.
• Previous experience in research environment preferred.

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 and 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.

What This Job Offers

• Career Level: Entry Level
• Industry: Religious, Grantmaking, Civic, Professional, and Similar Organizations
• Education Level: High school or GED