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Cedars-Sinai Clinical Research Associate I Hand Surg. in Los Angeles, California

Job Summary:

•Attend monthly research meeting

•Email weekly updates regarding the active research projects

•Act as patient liaison for clinical studies and be present in OR/clinic for necessary parts of the study.

o Identify patients eligible for studies

o Assist in consenting process

o Ensure appointments are scheduled and fulfilled in accordance with study protocol

•Ensure delivery of research materials to OR and availability for surgery

•Keep data from clinical studies up-to-date and available to research team

•Facilitate the IRB submission, revision process, and follow up on any questions from IRB staff in a timely

manner.

•Promptly report issues with research team so that they can be addressed in a timely manner.

•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.

•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.

•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:

Bachelor of Arts or Bachelor of Science degree required

Licenses:

Not Applicable

Experience:

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

Physical Demands:

Standing, walking, sitting at a desk

Working Title: Clinical Research Associate I Hand Surg.

Department: Dept of Orthopaedics

Business Entity: Academic / Research

Job Category: 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.

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