Job Description

Clinical Research Associate I, Per diem - Dept of Orthopaedics at CEDARS-SINAI summary:

The Clinical Research Associate I supports clinical research studies by coordinating with research staff and ensuring adherence to study protocols and regulatory requirements. Responsibilities include data evaluation and abstraction, completing case report forms, managing patient scheduling and follow-up, and assisting with regulatory submissions and budget management. The role maintains compliance with FDA, IRB, and HIPAA regulations while supporting clinical trial operations in the Department of Orthopaedics.

Job Description

Dr. Sean Rajaee and Dr. Mark Wu are looking for a motivated Clinical Research Associate I to join their team!

The Clinical Research Associate I (CRAI) will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists with study/long term follow-up research participants only.

Primary Duties & 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

Qualifications

Educational Requirements:

High School Diploma/GED
Bachelors degree in science or related degree preferred

Experience:

1-year clinical research related experience preferred

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

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

Req ID : 8888
Working Title : Clinical Research Associate I, Per diem - Dept of Orthopaedics
Department : Dept of Orthopaedics
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $19.50 - $32.86

Keywords:

clinical research, data abstraction, case report forms, regulatory compliance, clinical trials, patient scheduling, Good Clinical Practice, FDA regulations, HIPAA compliance, orthopaedics research

Job Tags

Local area, Shift work,

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