Clinical Research Associate I
3 weeks ago
Cedars-Sinai is seeking a Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study.
The Clinical Research Associate I 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.
Working Title: Clinical Research Associate I - Surgery Chair
Department: Research - Surgery Chair
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 - $29.87
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