Clinical Research Associate I, PER_DIEM - Dept of Orthopaedics

$40,560 - $68,349/Yr

Cedars-Sinai

Full-time - Entry Level

Hospitals

About the position

The Clinical Research Associate I (CRAI) at Cedars-Sinai plays a vital role in coordinating and implementing clinical research studies. This position involves evaluating and abstracting research data, ensuring compliance with research protocols, and maintaining patient confidentiality. The CRAI will work closely with various research professionals and assist in regulatory submissions, patient scheduling, and data entry, contributing to the advancement of medical research in orthopaedics.

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.

Requirements

• High School Diploma/GED required.
• Bachelors degree in science or related degree preferred.
• 1-year clinical research related experience preferred.

Nice-to-haves

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

Benefits

• Base Pay: $19.50 - $32.86